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News from the world of GMP

58707739 - grunge gmp (good manufacturing practice) stamp

EU and FDA Readiness

The quality management system (QMS) used in the pharmaceutical, medical devices, cosmetics and food industries contributes to the product safety and quality of your products.

We can help you with everything from design and planning to preparing for audits and inspections. Our portfolio also includes adapting your documents to your changing environment.

Our diverse and practical expertise spans the traditional pharmaceutical, API, medical device, biotechnology, biomedical, food and cosmetic industries.

All pharmaceutical quality systems must be at a high level at all times. And the best way to do this is without extensive preparation for an FDA inspection. Although the aim is to achieve a consistently high level of GMP outside the USA, most pharmaceutical companies prepare individually for an FDA inspection. This is because inspections in Germany are announced, whereas in the USA they are regularly unannounced.

The targeted preparation for the inspection only begins after the announcement, often at great expense. This leads to enormous tension and stress for everyone involved.

That is why we take care of your QM standards in advance, as a prerequisite for your company’s successful market access. Let our experts show you how to organise your QM system so that you can meet all the different requirements and successfully pass audits and inspections.

In co-operation with you, we want to achieve or maintain a consistently high GMP level so that you are audit-ready at all times.

But when are you ready for an FDA inspection? There are many questions, such as

    • Have you identified and assessed all possible internal and external compliance risks?
    • Are you aware of current inspection trends and possible focal points that relate to your product?
    • Have you already involved customers, partners and service providers?
    • Have you prepared the employees involved? Are their roles clearly allocated?
    • Do you know how to make your documents available efficiently?

We will answer these and other questions for you, and with you, so that you will be more than ready for your audit.

YOUR USE

  • We will look at your processes with a critical and unbiased eye, just as an auditor or inspector would do.
  • Your company then fulfils the QM requirements
  • Gain the tools to design your QM system to best meet the relevant requirements of standards/regulations
  • You know how to successfully pass an audit/inspection

OUR ORDER

  • Identifying, evaluating and managing potential internal and external compliance risks
  • Wir formen die Struktur, sowie den Inhalt und die Dokumentations-anforderungen Ihres QM-Systems
  • We integrate the QSR requirements into your company’s existing QM system
  • We work together with you to prepare for auditing/inspection by
    1. Document review
    2. Practical tips and tricks
    3. Clarification of terms and their meaning in implementation
  • We train correct behaviour during audits/inspections – formulating your answers
  • We prepare you for the procedures of the auditors/inspectors
  • We show you how to deal with deviations identified during audits/inspections
  • We will inform you about deadlines and sanctions in the event of deviations

Further services for the introduction of a quality management system etc. can be found here QMS and Hygienic.

Questions? Contact us:
Head of QMS
Mail: bettina.ernst@pitzek-consulting.de
Mobil: +49 151 146 112 93

Data Integrity – Requirements in the pharmaceutical industry

The EU GMP guidelines require detailed documentation of transfer plans and reports.

Data Integrity

The Automation

Automation increases process efficiency and system availability, while also improving quality and safety in the pharmaceutical industry.

A seamless, digitally recorded and legally compliant workflow is perfect for traceability and counterfeit protection. The error rate is significantly reduced by the automatic recording of production data. Relevant production data and resources are available at the right time. The smallest deviations are recognised, so that early, controlled intervention by the operating personnel is guaranteed.

In addition, recorded data from various systems is included in a performance check and potential for improvement is uncovered. The optimisation of process automation enables user-specific and predictive maintenance. For Pitzek GMP Consulting, it is very important to consider the entire life cycle of a system and to identify solution-orientated proposals.

Automatisierung

COMPUTER SYSTEM VALIDATION PLAYS A MAJOR ROLE IN THIS

Computer validation is the documented testing of software or a computer system and provides manufacturers of pharmaceutical products with documented proof that computer-controlled or automated systems deliver consistent performance in compliance with specified regulations.

The software is tested for practical suitability and reliability. It is then verified that the computer system used functions correctly after modifications, modernisation or new planning and is suitable for the purpose for which it is used. Automated systems are generally tested and validated in accordance with US and EU regulations. This gives you inspection security through documented measures and various tests with a 100% life science focus.

Contact at Pitzek GMP Consulting
Head of Automation/CSV
Julian Lösch
Mobil: +491719028741

Mail: julian.loesch@pitzek-consulting.de

 

Extraordinary Sabbatical

Manuel Klein
Interview with our colleague Manuel Klein

Kickboxtraining Thailand

“The option of a sabbatical should ideally be part of every working model. I think that’s important to our generation. But I know that Pitzek is one of the exceptional companies here.”“, says Manuel Klein, Project Engineer, Pitzek GMP Consulting.

Sonnenuntergang


Asia

From the Middle East to the Far East, the fascination of a new and unknown world – foreign cultures, historical sites, social commitment
Interview with Manuel Klein, Project Engineer, Pitzek GMP Consulting, with an extraordinary sabbatical in Asia
The word “Sabbath” comes from the Hebrew and refers to the seventh day of the week when no work is to be done and rest is to be taken. A mini-break, so to speak. Later it was even applied to the university context. Every seventh year, researchers were allowed to take a break from university life and devote themselves to their own research projects. The sabbatical itself is a working model for a longer period of special leave. As a modern company, we promote NEW WORK and the time off it offers our employees. Of course, this is assessed on an individual basis and must also be compatible with work. This brings us to the first question.

Pitzek:
Hello Manu, you once called your sabbatical a “modern sabbatical”. This could be a classic sabbatical year, unpaid special leave, time off, a gap year between A-levels and university or something similar. The term is pretty open.
What do you mean by that?

Manuel:
I see it primarily as an opportunity to broaden my horizons, not as an extended holiday to escape my problems. Some personal projects require more time than statutory or contractual annual leave, and a ‘modern sabbatical’ is great for that.

Pitzek:
What motivated you to take a sabbatical?

Manuel:
A thirst for adventure and wanderlust. Travelling has fascinated me for as long as I can remember and, if you can call it that, it’s also a passion for me. In the evenings, I often find myself on Google Maps studying countries, watching wildlife documentaries or playing a travel and geography quiz with my girlfriend.

During the coronavirus pandemic, I drew up a bucket list of things I still want to experience and see in my life. There was also a list for travelling. This included, among other things: Volunteering in a developing country or getting a diving licence and diving with sharks and much more.
When travelling was possible again without restrictions and one of the items on my bucket list just fitted in with the workload of my project, I jumped at the chance. After a few discussions with the management, it was clear that it was possible and I could go on my personal journey.

Pitzek:
The pictures speak volumes. Nevertheless, the question “Why Asia”?

Manuel:
There are several routes around the world on my bucket list. Central America and Africa in particular, which I would also have been very interested in. The nice thing is that the other routes don’t travel by themselves!
I was in Indonesia at the start of the pandemic, but then had to cut my trip short prematurely, so I still had unfinished business. Asia offers beautiful landscapes, delicious mangoes (I remember them) and lots of adventures.

Pitzek:
What inspired you the most there?

Manuel:
I was most impressed by the simplicity of things. Life is not simpler in terms of living conditions, but in terms of approaches. Moving with a lorry, van and 3 helpers? No! Everything with your own Honda Wave (scooter). People in Laos, Vietnam and the Philippines, for example, were not familiar with the phrase “wasting time”.
Of course, I was thrilled by the spectacular sunsets. But what really thrilled me was something that I hadn’t expected or even looked for. The reflection of my “ordinary” everyday life and the acceptance that things simply work differently in some places and that this is okay. I am very grateful for my background and all the opportunities I have been given in my life. It has helped me to understand a lot of things and push my cultural understanding forward.
Apart from that, a video I received from my colleagues singing for me at the Christmas market made me very happy. They told me how much they missed me. That really touched me.

Pitzek:
Which countries have you travelled to?

Manuel:
The order in which I travelled was something like this: Indonesia – Thailand – Laos – Philippines – Vietnam – India.

Pitzek:
Wow, that sounds really exciting, which state do you remember the most and why?

Manuel:
Of course I remember an incredible number of things, so I’ll just say a few words about each country.
Indonesia: I did a lot of yoga here, especially acro yoga (acro for acrobatics) with my girlfriend. It was extraordinary in the jungle atmosphere. We also climbed a volcano at sunrise and had breakfast there with our guide and held a small Hindu ceremony.
Thailand:
As a long-time martial artist, there was of course one thing on the programme: Muay Thai! (Thai boxing). Hard training in almost saturated air and afterwards a delicious Pad Thai with Chang beer. I learnt a lot about the sport and the practitioners. It was as exciting as it was exhausting. A Thai boxing afterwork session was of course unavoidable.
Laos: Teaching at the Transformation Centre in Vientiane, of course. More on this later.
Philippines:
Where do I start? With the aim of seeing whale sharks in Donsol, we took a tricycle (similar to a tuk-tuk) to the diving centre. The vehicle was designed for 3 people, five of us, me suddenly at the wheel, the actual driver on the roof. I’ll be brief: the clutch was preterite, the brakes were as effective as Jägermeister on a hangover and I was suddenly totally overwhelmed – bang! Suddenly there were onlookers everywhere and I was in shock in my bright yellow T-shirt (recognisable “laughs”). In the end everything went well, I just thought everyone in Donsol would know what had happened in the days that followed. We also celebrated Christmas with the “locals” in the Philippines and I went diving with thresher sharks in Malapascua. Great experiences.
Vietnam: Motorbike tour through the north of Vietnam. It was very adventurous, right up to the border with China. Very exciting and picturesque landscapes.
India: Clearly, tiger safari in Rajasthan. After 5 days I was finally lucky enough to see the young female T-41 Laila walking about 2 metres next to me. What a beautiful animal.

Pitzek:
What special experiences did you have there or where were you particularly involved?

Manuel:
I was particularly involved in Laos. I worked there for two weeks as an English teacher in a transformation centre. The Transformation Centre is a school for teenagers and young adults who have or have had problems with drugs and are being put back on the right track there. The centre consists of a school building, dormitories and a small farm with goats, chickens, a catfish tank and a vegetable garden. Everything is very rudimentary. 
The English lessons weren’t quite so easy, as I don’t speak Lao and don’t know the script either. But with our hands, feet and Google Translator, we managed to overcome the hurdles together. The great thing was the mix of teaching, sport and living together with the boys. Even if we weren’t able to have a good and intensive conversation, we still understood each other without a lot of words and had a lot of fun together. I learnt a lot there and hopefully they learnt a lot from me too. It really was a wonderful experience that I would never want to have missed.
One small thing: they had lots of small Siamese fighting fish in little jars. I took the fish and released them in the pond while the rest of the lesson began.

Pitzek:
Let’s take a look at our company. Not every company offers the opportunity to take a longer break. As a medium-sized company, Pitzek GMP Consulting is very progressive in the area of “New Work” and open to new approaches. are such working models important for your generation?

Manuel:
First of all, I am very grateful to have had this opportunity. In discussions with other travellers, there was always a lot of admiration for my employer for allowing me to do this. I would also like to say a big thank you to my colleagues who stood in for me during this time.
By definition, I belong to Generation Y. According to my research (Chat GPT), flexibility at work, education and lifelong learning as well as work-life balance are important to them. Now I can’t speak for one generation. I think it’s important to pursue your dreams and have an open dialogue with yourself and your environment. This also includes your employer. I am very happy that we at Pitzek GMP Consulting have the opportunity to realise something like this after consultation. I have a good relationship with my superiors and so it was no problem to simply go to our Managing Director’s office and discuss it with him. His door is always open! “The option of a sabbatical should ideally be part of every working model. I think that’s important to our generation. But I know that Pitzek is one of the exceptional companies here.” In my opinion, a modern sabbatical is only feasible if it is also economically viable – for both employer and employee. Of course, if you are in the middle of a busy, challenging project, such a sabbatical is more difficult to realise, and you should always be aware of that. It was just the perfect fit for me!

Pitzek:
Thank you very much for the flowers, and it’s great for the company to hear that. OK, to summarise, you had an incredible number of adventures and learned a lot about other cultures and your own self. It’s definitely an experience for life.

Thank you very much for the fascinating interview, Manuel!

Conclusion Pitzek:
We know exactly the same Manuel as an employee and colleague. We value you as very loyal, helpful, polite, caring, passionate and with the necessary mischief in your neck! We’ve never seen you in a really bad mood – on the contrary, we know you as a cheerful person and you can see your thirst for adventure when we look into your smiling eyes.

 

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INTERVIEW HÜTHIG PUBLISHING HOUSE WITH DIRK LEUTZ

(Managing Director, Pitzek GMP Consulting)

about changes in the pharmaceutical industry

“A system must be valid”

Increasing requirements in the pharmaceutical industry also pose new challenges for GMP consulting. Managing Director Dirk Leutz from Pitzek GMP Consulting explains current developments and trends in an interview.

P+F: A provocative question: Why GMP consulting at all? Why is it necessary? What is the need for it?
Dirk Leutz: We advise customers on all aspects of GMP in many areas. This starts with a feasibility study through to the validation of a system, whether for manufacturers, plant constructors or other suppliers. GMP transparently regulates the handling of such projects over the entire life cycle of a product or system. That is the justification for GMP.

P+F: Because these regulations are so complex that they cannot be fully understood by the individual operator, so you need specialist knowledge of these regulations?
Leutz: There are various reasons for engaging our GMP heroes. On the one hand, our customers are grateful to have a partner who is familiar with the latest technology on the market, the regulations and has contacts to strong suppliers. On the other hand, the customer has the expertise, but not the necessary resources. Another reason for working with consultants is that our project managers structure different trades with complex tasks in a targeted manner and successfully bring them together in accordance with the regulations.

P+F: Is it just a question of specialist knowledge of the regulations and necessary steps, or is it also about additional security?
Leutz: It certainly makes sense to have a partner at eye level who actively supports you in the process. At the end of the day, the operator is responsible for the result and naturally also ensures that we provide the required service.

P+F: Can long-term trends in the industry be recognised behind the upheavals of the pandemic period?
Leutz: In terms of project management, the requirement for our employees to be constantly present on site has fallen to a healthy level.
We are also noticing that some customers are more hesitant to place orders and are focussing more on budget and delivering the promised service.
Some topics that used to be commissioned to accompany a project are now being scrutinised more closely, or we are being asked to present alternatives. We are happy to take on this challenge and allow ourselves to be measured against the promised services.

P+F: What new interests of the operators and what corresponding services have emerged from these changes?
Leutz: Comprehensive services that are handled in a focussed manner with clear communication and the tools of a project manager in the interests of the project. On the one hand, the area of automation has been added for us. The desire for automation is not new, but its implementation is becoming increasingly popular. On the other hand, we have expanded our portfolio to include QMS. This enables us to help our customers set up their quality management system (QMS). This is an exciting and diverse area in which we are confident and able to help our customers. We believe that strong expertise is not available everywhere, especially in the areas of automation and QMS. For example, we advise and support customers during upcoming audits and provide support so that they are well prepared for an audit appointment.

P+F: With these extensions, will operators soon have a complete solution from a single source?
Leutz: We are strongly focussed on the core processes of the pharmaceutical, food and biotech industries; building and air conditioning technology or architecture are not our core areas. For these areas, we have competent partners with whom we work and whom we trust, while remaining true to our competences.

P+F: Can automation and artificial intelligence be a solution to the skills shortage?
Leutz: Automation and AI can replace labour, but these are not independent processes, because if a robot is to take over activities that were previously carried out by humans, there will be someone who has to look after these robots. As a result, the qualifications required are increasing and the demands on skilled labour are becoming even higher.
Artificial intelligence will become more and more prevalent, and we cannot and should not deny this. But it will be some time before AI is actually used in a process. The requirement in our industry is always that a system must be valid. Until I can prove this with sufficient accuracy, AI will not be used. A current example of the use of AI is checking documents or document sets for completeness, for example in validation and qualification runs or simulating processes using complex data sets.

P+F: How are you dealing with the changes in the labour market in recent years?
Leutz: We are facing up to the challenges of today’s world and maintaining values that we are not throwing overboard. We try to create a good mix from this. Employees are demanding more flexibility and alternative working models such as remote work and working from home. However, we also say that the quality of our work must constantly improve. If this can be achieved with new models and ways of thinking, that’s great, but if not, we may have to use conservative methods to help ourselves. The pandemic has forced changes in this respect, but has also shown that it can be done without compromising quality. This has accelerated more or less unavoidable changes.

P+F: If these new working models make a lot of things possible remotely – how does that fit in with Pitzek’s company motto, “GENIAL LOCAL”?
Leutz: It fits together very well. We are with the customer when it is important and right for the project, otherwise we are always close by and ready to drop by, even if it’s just for a quick chat and nothing is concrete at first.

The questions were asked by Ansgar Kretschmer, Editorial Office Pharma+Food.

About the person:
Dirk Leutz is a trained brewer and maltster and has a degree in food technology. With professional experience in the fields of aseptics, plant engineering and process engineering, he took over the management of Pitzek GMP Consulting in 2021. He describes himself as a “down-to-earth mentor”.

Pitzek thinks future

Mission/Vision
STATEMENTS ZU VISION & MISSION

We have given a lot of thought to our mission and the journey to our vision, with the involvement of our people, and have now written them down. We live our mission statement and our journey towards our vision with “Passion on Point” and hope that you will feel this in our cooperation and partnership.

At first glance, it can be difficult to tell the difference between a mission statement and a vision statement. On closer inspection, however, it becomes clear that although the two terms describe interrelated concepts, they refer to different stages of corporate goal setting. While the mission statement describes the immediate intentions of a company, the vision statement sets out future goals. Both statements are central to a company’s mission statement.

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News from GMP

58707739 - grunge gmp (good manufacturing practice) stamp

The new EU Annex 1 and the cleanroom industry 

i-Stock

Future hygiene requirements

The new EU GMP Annex 1 will be adopted in August 2022. It becomes effective on 25 August 2023. Until then, companies can make the necessary internal adjustments to meet the requirements.

In terms of hygiene requirements, EU GMP Annex 1 has become much more comprehensive.

On the basis of EU GMP Annex 1, processes for the control of contamination will have to be considered in detail. Considering issues such as disinfection/cleaning, equipment and personnel is becoming increasingly emphasised in CCS.

We’re happy to help you implement the requirements, find the best solution for you and provide you with our expertise in QMS and hygiene!

SERVICES HYGIENE

  • Development and revision of hygiene concepts for your company
  • Technical support for pre-planning your cleanrooms and determining requirements for all ISO/GMP classes
  • Advice on your in-house cleanroom cleaning or outsourcing the service
  • Preparation and delivery of cleanroom / hygiene training to your staff at all levels of the hierarchy, including procedures for donning and doffing
  • Advice on the implementation of pest control requirements
  • Preparation for service provider qualification audits

Other services including implementing a Quality Management System can be found here QMS and Hygiene.

Questions? Contact us:

bettina.ernst@pitzek-consulting.de
Mobil: +49 151 146 112 93

donations instead of gifts

Traditions are created through time and routine. Friendships through a good togetherness and common interests

The company Pitzek GMP Consulting (short: Pitzek) from Neustadt and Lichtblick meanwhile combines both.

With its “donations instead of gifts” campaign, the Pitzek company is once again doing without christmas cards and promotional gifts for corporate customers and stakeholders this year.

Sustainability in this case is not only the renunciation of these goods, but also the social investment of the money saved. A total of €1000 was donated to the Lichtblick day centre. The money will be used to support local efforts to combat social isolation. This is not the first time the Group has shown its social commitment: In previous years, it has already made a name for itself by donating money and goods. The company has also provided manpower for food distribution and other special activities. The employees of Pitzek are very welcome at Lichtblick and their energy is highly appreciated.

We´re all united in wanting to see more social cohesion and solidarity. By donating, we at Pitzek GMP Consulting want to set a good example.

Lichtblick would like to thank you for donating and getting involved. We are all looking forward to the next actions!

 

Robin Rothe, Leiter LICHTBLICK,                               Dirk Leutz, Managing Director, Pitzek GMP Consulting

 

OUR COLLEAGUE PETER RÖCKINGER

Extraordinary hobby.
Topic “A rogue who thinks evil of it”

“Alemanic Fastnacht”

– Guggemusik, brass music and fanfare groups set the rhythm and always inspire the spectators in the beautiful Black Forest!

Interview with our colleague Peter Röckinger, Project Engineer, at Pitzek GMP Consulting with an unusual hobby: “Membership in the pranksters’ guild”.

Dear Peter, why did you decide to join a jesters’ or rogues’ guild?

Peter Röckinger (following PR): I was born in Staufen, my family has always had a strong connection with the Guild, my grandfather was a very active member, my great-grandfather was a founding member and my mother is such a carnival enthusiast that she used to carry me in her pram. There I was apparently already the born prankster ;-).

“A rogue who thinks evil of it” is what you say when you want to comment on an outwardly ambiguous action that allows for a very delicate interpretation. But to think like that, you have to be a “rogue”. In the past, active pranksters or court jesters had the freedom of the fool, which made it possible to criticise existing conditions with impunity. Would you call yourself a real prankster or jester in the sense of the freedom of the jester?
PR: Making people happy and holding up a mirror to yourself? I like to do that because it definitely loosens up a round or two, creates a good atmosphere and makes people laugh. I love happy people.

The prankster is a joker with a mischievous streak. Does that apply to you?
PR: When I was a kid I was full of nonsense, now I am more experienced and therefore more considerate towards people. When you’re a kid you don’t think about what it means to other people.

Originally, Schelm comes from the Old High German “Skelmo”, meaning death. Later, the Schelm even became an epithet for battle-hardened knights. Do you live the life of a battle-hardened knight? If so, what was your greatest knightly deed?
PR: So in terms of professional life, I’m struggling with my first projects right now. It’s my first challenge since becoming a working student. I sometimes wish I had a knight’s armour to keep some things off.*laughs

Back to the Middle Ages, here the rogue originally comes from the time of fools, rogues or fools. In the Middle Ages, a jester or rogue was the name given to a person who was supposed to provide entertainment and amusement as a joker and who was conspicuously dressed..
Does this also apply to you in private? Do you like to entertain, have fun and dress conspicuously?

PR: I mainly like it cosy and simple. I’m not the typical class clown, but I like to spread good vibes and good humour and put a smile on people’s faces, if only with my positive nature!

In the game of chess, the fool (“Fou”) has the role of the bishop. At the same time, he can only be captured if he is threatened by two parties at the same time, and the piece that captures him leaves the board together with him.
The relation between the game of chess and the real court jester is thus as follows: Whoever beat the court jester at that time assaulted a defenceless person and thereby beat himself. Is the jester’s costume therefore like a little protection for you?

PR: *smile* During fool season and when wearing the Häs (costume), you are allowed to take one or two things out, hence the common fool’s freedom. That’s part of the appeal. However, at the end of the day you are trying to influence the people who are being integrated in a positive way, so that they go home with a good feeling, which is really important to me!

The Fool emerged as a character who has no fixed place in the estates order or society, who feels no obligation to any norms and falls out of the system in his human givenness.
In real life, do you like standing for something outside the norm and would you say that’s where you fall off?strong>

PR: I actually don’t like to be pushed into grids. I try not to think too much about it, to keep my light-heartedness. I’m not a fan of seeing things only in black or white.

Which brings us back to Pitzek GMP Consulting. Somehow our company is also out of the so-called frame. We are all individual and special GMP heroes and heroines who stand a bit “out of the box” in this rather conservative industry and also live it..
Do you think similarly about Pitzek GMP Consulting?

PR: I can definitely say that everyone can be what they want to be and that individuality is encouraged. This means that we really do stand out in the industry with a slightly different and younger look.

Gut, we come back to the fool and a completely different meaning.
In the tarot cards, the Fool stands for the boundless and the new beginning.
He awakens the curious child in us to dare something exciting or even to break our own limits. All this with the necessary attentiveness. Does this describe you? Are you curious, do you like to be boundless and yet mindful?

PR: Of course I am curious, but I am not boundless. I also enjoy coming to Pitzek GMP Consulting. The respectful and attentive way we deal with each other is important to me.

For me personally, this combination of light-heartedness and mindfulness is very inspiring, because it can be the key to pure joy of life. This joie de vivre and the necessary mindfulness are attributes that are lived in the company Pitzek GMP Consulting.Can you subscribe?
PR: Definitely. We do a lot of things together – events, after-work parties, company parties, etc., where the joie de vivre is never neglected. But we always look out for each other!

May you say something in conclusion?
PR: Thank you for the warm words and the almost profound interview! Learned quite a lot about pranksters.

Summary Pitzek:
If you know Peter as a colleague, he radiates just as much joie de vivre and light-heartedness as the prankster. Many colleagues are infected with his radiant laughter. We appreciate him as a very mindful person and can rely on our sunshine 100%

Prevention Campaign KRIPO Children’s Colouring Book

Prevention campaign Kripo children’s colouring book in the greater Neustadt area – Pitzek engages GENIAL LOKAL as sponsor

Kindermalbuch BDK

Cover children’s colouring book, Quelle: BDK


The issue of prevention for school-age children is very important. Children need to be reminded that they should not go out with anyone or get into anyone’s car without parental permission! Introducing this to children playfully with a colouring book convinced us!

The Association of German Criminal Police Officers (BDK), with its professional competence and its demands on political decision-makers, stands for a modern security policy in Germany that takes the interests of citizens in effective crime fighting and prevention into account to a high degree – we think that´s good!

In order to achieve this goal, the BDK publishes, among other things, DIN A5 brochures on individual prevention topics, which are distributed nationwide. They are available in pharmacies and schools, as well as in doctors’ waiting rooms and in target groups that correspond to the topic of the brochure.

By the way, the Kripo children’s colouring book is now also available in sign language on the BDK Youtube channel!

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EMPLOYER OF THE FUTURE – Pitzek GMP Consulting

“Award ceremony in Frankfurt by DIND (German Innovation Institute for Sustainability and Digitalisation) to Pitzek GMP Consulting”

– Patron Anette Zypries, former Federal Minister of Economics

About the award:

The German Innovation Institute for Sustainability and Digitalisation (DIND) awards the “Arbeitgeber der Zukunft” prize for forward-looking, high-quality workplaces. The initiative is supported by former Federal Minister of Economics Brigitte Zypries. The award recognises innovative companies with a clear digitalisation strategy that pursue sustainability goals and offer attractive working conditions. The focus is on modern management and employee friendliness. For example, flat hierarchies, flexible remuneration models or employee benefits as well as individual training and development opportunities are part of a holistic picture that is drawn up on the basis of an evaluation matrix that has been developed with the help of experts from business and science.

Picture DIND:
From left to right: Silke Fuchs (Head of marketing&customer services, Pitzek GMP Consulting GmbH), Brigitte Zypries (former Federal Minister of Economics), Dirk Leutz (Managing Director, Pitzek GMP Consulting GmbH)

About the awarding:

As a special highlight, Pitzek GMP Consulting was able to receive the award at the award ceremony in Frankfurt on 21 March 2023 and enjoy the festivities together with the patroness Brigitte Zypries (former Federal Minister of Economics and Justice) and other award winners.

“We are delighted and very proud to have been recognised as a sustainable company. In order to receive the ‘Employer of the Future’ trophy, we have been thoroughly scrutinised. We were able to score points in the area of digitalisation with our SharePoint solution and at the same time with our website as well as the mission statement that it contains and, above all, lives by. The opinions of our employees via kununu and finally our employer branding of the future with the keyword “NEW WORK” have also contributed to this,” says Silke Fuchs, Head of Marketing & Customer Services, Pitzek GMP Consulting GmbH, Head Office Neustadt/Wstr.

About DIND:

The German Innovation Institute for Sustainability and Digitalisation (DIND) supports companies in making themselves fit for the future. To this end, DIND cooperates with experts from the business, science and political sectors, carries out studies on behalf of its partners and analyses companies with regard to important aspects of their future viability. Examples of successful transformation should provide important impulses for business.

STRONG TOGETHER – MEMBER COMPANIES OF THE BVMW


Being strong together, we are now also a member of BVMW, the network of medium-sized companies, and we are happy to support the solidarity of medium-sized companies! It’s great to be part of it! We are happy to be available to other members for questions or just to exchange ideas and look forward to networking, friendly conversations and great events.

#midsize #medium #sized companies #rhinelandpalatinate #pharma #biotechnology #consulting #qualification #quality management #validation #engineering #automation #qms #quality management system #projectsaoundyou

Publication “Karriereweg in der Pharmabranche” with Pitzek GMP Consulting

Publication of the book “Karriereweg in der Pharmabranche” by Dirk Geest

“Interview with Dirk Leutz, Managing Director, Pitzek GMP Consulting GmbH”

Careers in pharmaceuticals – 18 experts interviewed

The systemically important pharmaceutical industry is a mainstay of our healthcare system and our economy. It is a diverse industry, offering a wide range of jobs, training and study opportunities and, not least, great career prospects. However, like many other industries, it is currently suffering from a shortage of skilled workers and is concerned about attracting new talent.

The aim of this book in the “Career Paths” series, which aims to improve career and study guidance, is to give young people who are interested in working in the pharmaceutical industry an impression of the actual working day, real working conditions and career opportunities in the sector. A total of 18 experts, including Dirk Leutz, Managing Director of Pitzek GMP Consulting GmbH, have contributed to the book.

“I am personally very proud that I was able to interview our open and passionate managing director with an eye for detail and that we made it into the book. I hope that we can give a little help to all the newcomers, and perhaps to those who are looking for a change of job, in their choice of career. Of course, we are always happy to receive unsolicited applications,” says Silke Fuchs, Head of Marketing & Customer Service, Pitzek GMP Consulting GmbH (certified GMP consultancy for the pharmaceutical industry).

In a standardised interview, the experts were asked about their daily work, how they entered their profession (qualifications), what drives them (motivation), the biggest challenges in their daily work (demands & goals) and what they recommend to young people when choosing a career (tips). The aim is to avoid misunderstandings and disappointments when choosing a career, during training and especially later in professional life.

Information about the book:

Title: “Career paths in the pharmaceutical industry – insights into everyday professional life”, published by BoD, 2023,

Available in the next few weeks in around 6,000 bricks-and-mortar bookstores, in over 1,000 online bookstores

in 30 European countries and via Apple iBooks and Kobo in the USA and Canada!

About the publisher:

Dirk Geest, Diplom-Kaufmann (FH), publisher & book author, launched the book series “Karrierewege” together with Dr. Antje Wolf in 2014 to improve career and study orientation and has already published 15 books: www.dirkgeest.de

We´re proud of this – Safe fuelling in areas subject to explosion hazards

WAGO-Referenz

Reference project – Safe fuelling in areas subject to explosion hazards

 

Sicher tanken im Exbereich
“Thanks to the solution of optical process monitoring with the system integrator TTS Automation and the connected WAGO system control, nothing stood in the way of the technical implementation,” says Julian Lösch, Senior Project Manager, Pitzek GMP Consulting.

Source Image: WAGO GmbH & Co. KG


The customer
WAGO – a reliable partner for the industry. WAGO has grown continuously and today employs around 8,600 people all over the world. In the industry, in railroad, and power engineering, in marine and offshore areas, and building and lighting technology – our products and solutions ensure safety and efficiency. Nine international production and sales locations and 20 other sales companies and representatives in over 80 countries put WAGO on-site for its customers wherever they are.
 

Our project
TTS Automation, a manufacturer of explosion-proof camera solutions in process and plant monitoring, has developed a system for safe loading processes. The intelligent industrial camera allows tank loading process monitoring so that anomalies can be detected at an early stage. TTS uses WAGO’s IoT Box, the intelligent interface for image evaluation.

Detect events before they become dangerous
Back in 2009, TTS Automation developed the first camera system for areas subject to explosion hazards. The idea came about because of the special explosion protection requirements for industries involving hazardous and explosive atmospheres in the form of mixtures of air and flammable gases, vapours, or mists. In developing an explosion-proof solution for tank loading, TTS Automation, based in Neustadt an der Weinstraße, faced a major challenge: Such operations are complex because they go beyond mere process and plant monitoring. Loading irregularities must be quickly detected and corrected.”Our experience has shown that leaks at loading fittings are often preceded by events such as pipeline jerking or tanker sagging. So we wanted to develop a tank loading solution that detects hazards before they occur,” says Michelle Striegel, who is responsible for marketing and project management at TTS Automation.

It quickly became clear that the camera needed some sort of intelligence to preventively detect and evaluate potential hazards. This requires functional process control on the plant side. Searching for a suitable system, TTS Automation came across WAGO: “The WAGO IoT Box provided exactly the intelligent camera system component we needed,” recalls Wolfgang Laufmann, Global Key Account Manager Digital Plant at WAGO and contact for the TTS Automation project.

TTS Automation’s intelligent, automated industrial camera is to contribute to safe, quality-enhancing tank loading in explosive areas. It covers safety at three different levels: protecting people, the plant, and the environment. To this end, the intelligent system camera films the entire workflow at different points:

Julian Lösch, Pitzek GMP Consulting’s Senior Project Manager Automation and Computer System Validation, planned the project. He wanted to add value for hazardous areas in which loaders and unloaders no longer have to be in the danger zone: “Early event detection with an intelligent system interface between the camera and the plant ensures greater personal safety, contributes to environmental protection, and increases plant quality.”

The camera is small, so it takes up little space in the danger zone and can be mounted quickly and easily anywhere,” says Lösch. In addition to compactness, TTS Automation has focused on modular design.”The interaction of optical process monitoring and the WAGO IoT Box makes the industrial camera compatible with existing systems and retrofittable at any time,” says Lösch.

Intelligent interface between plant and camera
Das Kernstück in der Entwicklung der Schnittstelle lieferte WAGO: „Die WAGO IoT-Box machte die intelligente Industriekamera schließlich komplett und eine Verknüpfung aller Anlagenteile miteinander möglich”, erklärt Wolfgang Laufmann. Der verbaute WAGO Controller PFC200, als Komponente der IoT-Box, ist ein intelligentes Gateway, das auf Anlagenseite die Kommunikation zwischen den Systemen herstellt und auf IT-Seite die Integration durchführt. „Quasi ein intelligentes OT-/IT-System“ so Laufmann. Der Controller bietet mit seiner hohen Flexibilität zwei verschiedene Ansätze: Das skalierbare System kann entweder als Einzelkomponente bereits bestehende Schaltschränke bei WAGO erweitern oder aber als Komplettlösung für Anlagen in Form einer fertigen IoT-Box geliefert werden. „Das erspart dem Endanwender einen enormen Planungs-, Zeit- und Prüfaufwand“, Wolfgang Laufmann., Global Key Account Manager Digital Plant bei WAGO. Über potenzialfreie Kontakte aus der Anlage erfassen die Eingangsmodule an dem WAGO PFC200 die Signale und Ausgangsmodule aktivieren Signale wie Warnleuchten, Blitzer oder Hupen im Gefahrenfall bei einer Tankbeladung.

“A collaborative project has shown us that working together in partnership can be successful only if each partner is recognized on equal footing.” Wolfgang Laufmann, Global Key Account Manager Digital Plant, WAGO

Wolfgang Laufmann
Global Key Account Manager Digital Plant, WAGO

 

weiterlesen

News from GMP world

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The new Annex 1 and the effects during sterile product manufacture

About visual inspection

General questions about the biggest challenges for our sub-project manager, Arvid Duchardt.

What do you think are the biggest challenges in the operation of the new Annex 1?
Arvid D.:
The hygiene requirements have been changed from < 1 KBE to “no growth” (≙ 0 KBE). This means in practice that sterile filling can be performed only in a fully automated system. There is no human element anymore.

What effect does that have on planning systems in industry?
Arvid D.:
RABS and insulators used to be a precautionary measure. Now the situation has switched. Operators have to justify not using RABS and insulators and ensure that new systems operate fully automatically.

Who is affected by the changes?
Arvid D.:
So far, Annex 1 has been limited to parenterals. The new one is expanded to agents, sterile auxiliaries, primary packaging, biopharmaceutical products, and non-sterile products such as creams, ointments, etc.

 

Brief notes and information about visual inspection

GMP regulations
The new version has been active since 22/8/2022. There are four sections on visual inspection, and the deadline for implementation is 25 August 2023!

General Annex 1 fundamentals for visual inspection:

  • 100% inspection
  • Catalogue and classification of defects
  • Risk analysis for the defect pattern
  • Assessment and CAPA for each “critical” defect
  • There must be suitable, controlled conditions for lighting and background

Annex 1 personnel fundamentals in visual inspection:

  • Personnel must be qualified regularly – at least once per year
  • Test sets from the defect library
  • Bracketing
  • Eye test
  • Qualification in the worst-case scenario (speed, container, end of shift)
  • Reduction of distractions and establishment of inspection duration and breaks – employees should display no signs of fatigue at end of shift

Annex 1 system fundamentals:

  • Validation of automatic systems
  • Validation must be performed with defect patterns
  • System must be better than manual control
  • Knapp test set
  • Function check (dummies) at the start of a batch
  • Routine for NOK

Summary of a qualification process by an organization such as Pitzek GMP Consulting:

FUNDAMENTALS TRAINING

  • Training kits
  • Defect assessment lists
  • Photo documentation
  • On-the-job training

QUALIFICATION

  • Assessment by means of test

RE-QUALIFICATION

  • Assessment with test or AQL analysis

EYE TEST

  • Generally before personnel are hired
  • Recurring (at least once per year)

Questions? Contact:

arvid.duchardt@pitzek-consulting.de
Mobil: +49 151 511 192 24

 

Our colleague – Benjamin Peschke

Hobby & responsibility
A clean community

“We keep our community clean”

– Streets, paths, green areas – all full of litter. Everyone complains, but nobody does anything about it.

Interview with our colleague Benjamin Peschke, Sales Manager at Pitzek GMP Consulting: “We take personal responsibility for keeping our community clean!”


Benjamin, what gave you the idea of starting a private initiative to clean up litter in your community? Isn’t that excessive? Don’t you pay property taxes for that?

We always notice streets, paths, and green areas in our community that are full of litter. Everyone complains, but nobody does anything about it. That bothered me. I am for actions, not words, my family and I decided to get to work, collect the litter, and get rid of it. People litter the community, and if the municipality can’t keep up, it doesn’t matter how much property tax I pay.

You’re setting a great example. How did you get started?
The example is especially important for the kids, who we want to sensitize for later. We want them to learn that you have to get to work yourself if you want to change things. Litter is especially bad for animals, and our kids love animals.
So they got their own trash grabbers, which happened to be free gift with a children’s magazine. From the first, they had a blast making the rounds and picking up litter. They may have gotten a little bit tired after a while. 😉

How did people find out about it, and how did the municipality react?
We contacted the municipality. They were enthusiastic and gave us a sponsorship. They provide grabbers and trash bags, pick up the trash at a specific location, and haul it off. We also participate in a municipality “Take Out the Trash” day. We contribute to keeping our community clean and feel good about ourselves because we have helped the environment.

Were you able to recruit more people from the community to help you with your project?
My wife is working with the kindergarten to organize a private “Take Out the Trash” day. She is active in the parents’ group there. It is especially educational for the kids there and gives them a new way of looking at the world, so many parents were enthusiastic as well.

What do you do with the larger pieces of trash like tires and mattresses? You see things like that once in a while in our communities. You need more than a grabber for something like that.
Our solution is a great trash app. We can take a picture and send it to the municipality, and they come and pick it up. It works really well!

So what is your overall impression?
One thing is that our daily route to the kindergarten is clean. Another is that if you want something done, you sometimes have to do it yourself!

Pitzek’s conclusion:
There are parallels to the job you do for us. We know you to be a man of action. Your vigorous activity in this project reflects the personality we have seen on display in your work as sales manager at Pitzek GMP Consulting. You give it everything you’ve got, take responsibility, keep your cool, and are always in a good mood! This has been a great benefit to the company. We are very thankful.

10 years Pitzek GMP Consulting

Pitzek GMP Consulting joins customers, partners, and employees in looking back on ten years of corporate success

Many representatives and partners from the pharmaceuticals industry and greatly appreciated Pitzek GMP Consulting GmbH employees met on 23 June 2022 in one of the oldest locations in the Palatinate, in Philipp Eins in the old cathedral city of Speyer, Germany to celebrate the company’s ten-year anniversary. Managing Director Dirk Leutz and founder Thomas Pitzek delivered moving speeches not only honouring the company’s successes, but emphasising years of cooperation and partnership and the company’s corporate culture. “We all get older, but if we ultimately change, who cares?” was Managing Director Dirk Leutz’s message.

Among the highlights were the keynote address by former Bundesliga referee Knut Kircher; a very enjoyable, relaxed speech on “Continuous manufacturing” by Steven Miller, who is part of the executive management of Hecht Technologie GmbH; and refreshing cocktails, great food, and benefit goal wall shooting for the LICHTBLICK meeting place in preparation for the World Cup! The guests were also enthusiastic about the unusual location.

Unlike most corporate ten-year anniversary celebrations, this one involved customers, partners, employees, and a big party. And there was plenty to celebrate.Exactly ten years ago, Dr. Denise Pitzek und Thomas Pitzek opened the first office in their private house in the Palatinate. The headquarters has been at Neustadt an der Weinstraße for seven years. During this period, the location has seen great successes. The office in the Wallgasse in Neustadt is one of four locations and ensures that employees and companies from around the region can get together. You have to be a little bit crazy to work at Pitzek, but it also helps, as the company emphasises in its image spots and elsewhere.“Not taking ourselves too seriously and still being down-to-earth, responsible, and professional, meeting clients on an equal footing – that’s what we’re about.  There are very few people who do everything right, but we have done at least most things right – otherwise we wouldn’t be where we are,” ssays Thomas Pitzek, founder of Pitzek GMP Consulting GmbH.

Values and corporate culture were central issues at the event. In their opening remarks, the founder and the managing director, Thomas Pitzek and Dirk Leutz, emphasised the company’s special spirit. Pitzek GMP Consulting is a passionate company in which the corporate culture, respect for each individual’s personality, and long-term commitments and team-oriented cooperation are greatly valued. Another advantage that Pitzek GMP Consulting GmbH enjoys and that distinguishes it from the competition in the area of teamwork, customer orientation, and reliability is the employee philosophy:WE ARE WHAT WE PRACTICE!

Since its founding in 2012, Pitzek GMP Consulting GmbH has successfully implemented hundreds of challenging projects, initially as a family-run company. It now employs more than 40 specialists in pharmaceuticals, food, and biotechnology. Under#projectsaroundyouLeutz looks out for the team of more than 40 consultants and tracks needs and requests from employees, applicants, and life science companies  W”We are made up of very diverse regional teams and practice our identity in our own way, and we are proud of that. We are currently advertising more positions and are really looking for help constantly thanks to our continuous growth – but that help must fit perfectly with our team,”says Managing Director Dirk Leutz.

Marketing, sales, and project teams all pull together and cooperate in further promoting brand awareness.“Our in-house marketing, which we introduced almost seven years ago, has established Pitzek GMP Consulting as a special brand for high-quality consulting and services provision in the pharmaceuticals, biotech, and food industries,” says founder Thomas Pitzek. 2022 has been heavily influenced by the new “GENIAL, LOKAL” campaign, which breathes fresh air into our image.

 

About Pitzek GMP Consulting GmbH
Pitzek GMP Consulting offers holistic consulting for regionally, nationally, and globally active pharmaceuticals, biotech, and food companies – and has been doing that for ten years. The recipe for the company’s success is solidly based industry, process, and strategy knowledge; far-reaching familiarity with national and international markets; and a strong focus on the regions around the company’s locations. From new construction to comprehensive restructuring to minor adjustments, Pitzek’s goal is to develop GMP-compliant concepts, effectively optimise processes, and reduce costs, all while carefully adhering to requirements and regulations.

 

Ingeniously Global, Ingeniously Local

Consulting competence is right around the corner. As it has been for ten years..

Pitzek GMP Consulting, your pharmaceuticals, biotech, and food technology expert in the Rhine-Main-Neckar area and Berlin, Germany, and Vienna, Austria.

NNew career opportunities and consulting competence acquired by changing the location of Pitzek GMP Consulting GmbH’s GMP experts..

The Austrian subsidiary of Pitzek GMP Consulting is moving from Salzburg to Vienna.

There are a variety of factors that affect a company’s growth and thriving. The company is changing its location to be closer to the pharmaceuticals industry and thus to the customers. Vienna has established itself as the commercial hub of the Austrian pharmaceuticals industry. A strong location requires bold ideas – the kind the Pitzek GMP Consulting can provide.

All customers, partners, and advertisers should therefore note a new Pitzek GMP Consulting GmbH (Austrian subsidiary) for both appointments and correspondence.

In future, the office can be reached atPitzek GMP Consulting GmbH
Subsidiary Austria
Weihburggasse 21/13
1010 Wien

Mobil
Festnetz  +43 (0)143 800 58 

New outlook with a new managing director
Since August 2021, Dirk Leutz has been the new managing director and thus the man responsible for advancing Pitzek GMP Consulting’s business development, as he has been doing with great dedication. Says Leutz, “Previously, I was Technical Manager/Division Manager Engineering for Pitzek. So I am at home in the organisation. I am looking forward to my new challenge and to being able to provide new ideas.” Thomas Pitzek, founder of Pitzek Consulting, adds, “We are convinced that Mr Leutz, with his expertise and level-headedness, is a find for our company and our customers.” In the pharmaceuticals circles in Vienna, we intend to remain very close to our customers. This ensures efficiency with reduced costs, quick reaction times, and short travel distances.”

Pitzek GMP Consulting has been offering purposeful project management in the GMP area for pharmaceuticals, biotech, and food technology companies for ten years. Its services are customised, fast, uncomplicated, effective, and customer-oriented.

From its Location Neustadt/Weinstraße Pitzek can quickly reach customer locations in the Palatinate and the Rhein-Main-Neckar area. Pitzek offers the same services in the   from the Berlin branch , supporting customers with all its expertise. 

From new construction to comprehensive restructuring to minor adjustments, Pitzek’s goal is to develop GMP-compliant concepts, effectively optimise processes, and reduce costs, all while carefully adhering to requirements and regulations.

“Our customers in the Rhine-Neckar area and in the Northeast of Germany enjoy local proximity to our Neustadt/Weinstraße and Berlin branches. This ensures reduced costs, quick reaction times, and short travel distances. In other words, we are looking for proximity to the customer in a literal sense,” says Leutz.

CLEAN REALITY” WEBINAR – WITH IWT AND DR WEIGERT

“CLEAN REALITY” – doing it right once is enough!

On 3/3 at 3:00 PM, we started the fascinating second part of the IWT Cleaning Excellence by Tecniplast and Dr Weigert – Systematic hygiene webinar, addressing the main issue of “Cleaning in the GMP-governed environment”.

We are very pleased that the second part of the webinar was also a complete success. We started off in 2022 with almost 100 participants. The moderators addressed many interesting questions and hopefully were able to answer them satisfactorily.

We would like to express heartfelt thanks to all webinar participants and are pleased to have been able to offer 60 valuable minutes covering everything from implementation to validation.

You couldn’t find the time or got stuck in another meeting? Then we invite you retroactively to the second part of our joint webinar with IWT and Dr Weigert.

Enjoy 60 stimulating minutes on topics ranging from implementation to validation:

 

NEWS FROM THE GMP WORLD

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CLEANROOM TECHNOLOGY AND CONTAINMENT

Annex I and what to watch out for in material and/or personnel locks

The biggest contamination hazard in cleanrooms is from personnel. Transferring equipment and material into the cleanroom also involves critical contamination hazards.

All activities that could affect cleanroom classification status should be given careful attention. Suitable checks must be made regularly. Such checks include particulate and microbial monitoring. Particulate monitoring can be performed by a continuous measurement system or as spot checks at regular intervals.

Equipment and material transfer and personnel access to classified areas should be through material or personnel locks and in one direction only. Personnel must undergo washing and changing processes before entering classified areas.During the lock process, material is made cleanroom-friendly by unpacking or disinfection. For transfers to an aseptic or sterile area, a sterilisation step should be performed if possible.

If no sterilisation is possible, a suitable measure should be validated and performed so that contamination risk is minimised. Suitable measures include effective transfer disinfection, quick transfer systems for isolators, or, for gaseous or liquid materials, an anti-bacterial filter.

An innovation for personnel and material locks that has been added to Annex 1 is spatial separation between personnel and material locks. If such separation is not possible, at least a temporal separation should be considered.

We recommend using separate locks from at least Cleanroom Class B if our risk analysis indicates a heightened contamination hazard. This means separate locks for incoming and outgoing materials and separate locks for incoming and outgoing personnel.

Would you like consulting on material and personnel locks in cleanrooms? Don’t hesitate to contact us at:

juliane.schulz@pitzek-consulting.de
Mobil: +49 (0) 160 178 38 20

OUR COLLEAGUE, SABINE HELL-KUNCINGER

Sabine Hell-Kuncinger, Officemanagerin

Hobby and passion
Essential oils

“Essential Oils”

and their connection to GMP – complete purity

Synthetic or harvested from natural sources by means of steam distillation, extraction, or squeezing plants or parts of plants.

Interview with our colleague from Vienna, Sabine Hell-Kuncinger:

So, Sabine: Why essential oils?
They work at all levels (physical, mental, psychological), and a scent molecule reaches the limbic system in three seconds.

Essential oils have been used for thousands of years, and they can be found in every herb, every plant, in blossoms, and so on. They are PURE NATURE – which is why these molecules manage to penetrate our cell membranes and reach directly into the cell and its nucleus.

Essential oils can have stimulating effect and work as pick-me-ups (these include orange, lemon, lime, and grapefruit – that is, all citrus oils) – and in this form are perfect for our daily challenges at work; they can calm you and your spirit (most people are familiar with lavender); they can cool you off and stop your headache (peppermint, spearmint); they can stop or at least slow inflammatory processes (frankincense), relieve colds (hot tea with lemon, ginger, and a special “thieves” oil blend), and much more.

So, Sabine, to summarise: These oils are extremely flexible. About as flexible as we have to be in our job, right? Do you pay attention to how the oils are produced and were they come from?  Yes, I was really impressed by one company because the quality of its essential oils was absolutely pure. Starting with planting, all the production steps through to packing were carefully monitored and documented precisely.That is GMP style.

You can even visit the farms where individual plants are raised and help harvest them.

How varied are these oils? Are there special characteristics?
Each essential oil, even if it comes from the same area, smells different. Depending on the weather conditions, the essential oils have a slightly different composition each year. A single drop of rose essential oil requires about 30 petals. That comes to between three and a half and five tons for a litre of essential oil.

By the way, rose is considered a mood enhancer and is very helpful for depression.

Can I use these oils in my daily routine?
Of course essential oils can also be used for cooking. If you are baking, you can use vanilla, lemon, and so on. If you are cooking, you can use basil, sage, dill, and so on. Either way, essential oils can provide the extra kick you need.

What is the best way to use essential oils?
You can apply them to your skin, evaporate them with a diffuser, and take some of them orally.

Summary:
The thing that essential oils have in common with Pitzek GMP Consulting services is that a selection of both can be used in a targeted manner to address specific issues!

SAVE THE DATE! LOUNGES – CLEANROOM PROCESSES, 17-19/5/2022, KARLSRUHE TRADE SHOW

Ortsschild

The cooperative way – Pitzek GMP Consulting meets gat & H+E Pharma!

17 -19 May 2022
Booth No. G 2.5 | Messe Karlsruhe

Visit us at our joint booth across from Lecture Room 6

Why should you be there?

Because you are also looking forward to a live trade show. Finally seeing others in person.

Because, at our joint booth No. G 2.5shared with our parter gat, or Gesellschaft für Automatisierungstechnik mbH) and that of our guest exhibitor, H+E Pharma GmbH, which is diagonally across from Lecture Room 6, you can get answers to the general questions about our joint approaches that you have always wanted to ask.

Because the two presentations of Pitzek GMP Consulting will give you fascinating insights into “QMS & GMP” and “FDA readiness”.

We are looking forward to an attentive audience.

But that is not all: Are you looking for a contact at the booth who is dedicated to you and your concerns? Following our guiding principle, “project as service”, we would like to offer you a firm appointment for a conversation. To arrange it, please contact our marketer, +49 6321/9 26 26 10 oder silke.fuchs@pitzek-consulting.de.

REGISTER FOR YOUR FREE ONLINE VISIT at expo_lounges_besucherregistrierung with your registration code e6YXXGVD6.

After registering, you will find an option for entering your data and be able view your visitor code and other information about the schedule and the fascinating presentations.

IMPORTANT: Registering as a participant is a condition of your free entry.

 

 

 

Information about the 2022 costs:

For registration by 13 May 2022 (internet only)
• Entry with an invitation day pass: EUR 0
• Entry without an invitation day pass: EUR 15
• Discount entry day pass (official representative, public servant, student): EUR 15

No registration is possible from 14 to 16 May 2022.

For on-site registration 17 to 19 May 2022
• Entry with an invitation day pass: EUR 50
• Entry without an invitation day pass: EUR 100
• Discount entry day pass (official representative, public servant, student): EUR 50

Cancelling or changing an appointment
• by 13 May 2022 – processing fee: EUR 0
• starting on 14 May 2022
– Visitor with an invitation day pass – processing fee/day: EUR 250
– Visitor without an invitation day pass – processing fee/day: EUR 250
– Visitor with discount entry day pass – processing fee/day: EUR 250

We are looking forward to meeting and speaking with you at our Booth Nr. G 2.5

Wir freuen uns jetzt schon auf Sie und sympathische Gespräche an unserem Messestand Nr. G 2.5, diagonally across from Lecture Room 6.

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SAVE THE DATE! PHARMACONGRESS IN DÜSSELDORF/NEUSS, 31/05/ -1/6/2022



Why should you be there?

Because PharmaTechnica and PharmaCongress are returning to their familiar form this year.

Because you will benefit from more than 50 highly professional presentations by GMP inspectors and pharmaceutical companies.

Because you will also meet leading European suppliers for the pharmaceuticals and biopharmaceuticals industries at the familiar PharmaTechnica exhibition.

Because the evening and networking events are fantastic.

Because we are there for you at the PharmaTechnica exhibition.

Because, as co-sponsor, we are looking forward to seeing and speaking with YOU – at Booth No. 24!

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SAVE THE DATE! ENGINEERING SUMMIT, 20 -21/7/2022 IN THE DARMSTADTIUM

Why should you be there?

Because the latest questions about best practises, trends, and strategic developments in plant construction will be discussed and, in the areas of life sciences and pharmacy, answered by us.

Because you will benefit from hearing the best speakers and moderators.

Because you will find out what is happening in the industry in these times of crisis.

Because the schedule speaks for itself!

As co-sponsor, we are looking forward to seeing YOU at our booth!

As a participant, you can expect the following focuses:

  • How is European plant construction handling the pandemic?
  • What opportunities are to be had from industry transformation to sustainable management?
  • What role do natural gas, LNG, hydrogen, and Power2X play here?
  • How is digitalisation pushing the industry forward, and how is utility to be had from it?

What methods and processes are promising? How is personnel work changing in the face of competition for talent, and how can remote leadership work?

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New Power at the Head of Pitzek GMP Consulting

Since 1/8/2021, Dirk Leutz (left) has been the new Managing Director of Pitzek GMP Consulting GmbH. He succeeds Dr. Rainer Maué (right), who left the company of his own accord. He is facing new challenges.

We regret to announce the departure of Dr. Maué, who pursued company business with great personal dedication, moving it forward. We would like to thank him for his valuable contributions and wish him all the best for his future endeavours.

At the same time, we are very pleased to announce that Dirk Leutz, who had been serving as Technical Manager/Division Manager Engineering, will be the new Managing Director. We are convinced that Mr Leutz and the Pitzek GMP Consulting team can continue with the successful work of the founder and former Managing Director and refine it.

After his training as a brewer and maltster, Dirk Leutz studied food technology. He began his career at Krones AG. It was there that he first encountered aseptic techniques. After a few stages in his career, he took over as technical and personnel head of a large team and in 2019 joined Pitzek GMP Consulting GmbH as departmental manager in international plant construction in the beverages industry. From the very beginning, he has loved Pitzek GMP Consulting’s corporate philosophy, and he established himself quickly in the company.

“Dirk Leutz is a familiar colleague for us and a familiar point of contact for our customers. We are convinced that his expertise, empathy, and down-to-earth demeanour will enable him to make great contributions to our company’s further growth,” says Thomas Pitzek, founder of Pitzek GMP Consulting GmbH.

Leutz is greatly looking forward to his new duties and intends to continue to press forward with positive corporate development and competent services in the pharmaceuticals industry. He considers systematically orienting on customer utility and fostering customer trust to be especially important. Initially, of course, he will continue to be available to customers in his old function as Technical and Division Manager Engineering.

He describes the challenges facing him as follows: “Every day, we are tasked with finding a balance between meeting the stringent demands of our customers and transacting projects on an equal footing within the planned framework. I am looking forward to working with my team to develop and establish more innovative solutions for our customers and business partners. We want to foster exceptional trust in our customers by offering the best possible service and close, professional support on the part of our GMP experts.”

Pitzek and Leutz are excited about their future together: “Pitzek GMP Consulting has a great deal of potential for developing more specific competences and solutions for our customers in the GMP-regulated environment.”

More Manpower in Sales

A change of perspective – from project engineer to sales manager

Benjamin Peschke was previously employed at Diversey Deutschland GmbH and Co. OHG.

He has several years of experience in various areas of the chemicals, pharmaceuticals, and cosmetics industries and therefore a broad range of expertise. At Pitzek GMP Consulting, he has two more years of experience as a project engineer, some of it at the customer’s premises. His enthusiasm for collaboration with customers and colleagues in projects that are often complex and technically challenging knows no bounds.

Mr Peschke can now pursue his great passion for attractive solutions focused on customer utility in his new position: Sales Manager. He is hugely looking forward to this new challenge. “Most people think that salesmanship is the same as talking. But you have to know that listening is the most important element in my job,” Peschke says.

As someone who used to be active in handball, Peschke knows the importance of performance and teamwork very well. The new Sales Manager is looking forward to fascinating, friendly conversations with customers. “An assumed persona and canned pitches are just not my thing. If I used those techniques, I would not be half as successful as I am with relaxed, open dialogues on an equal footing with the person I am talking to. This will be an exciting time.”

Mr Peschke will pay even more attention to our customers, helping them with questions about GMP and support by our experts.

We are looking forward to his assistance and wish him all the best in his new position.

Would you like to meet Mr Peschke? Don’t hesitate to contact him directly at

Mobil: +49 171 564 76 92
E-Mail: benjamin.peschke@pitzek-consulting.de

OUR COLLEAGUE MAREN KETTNER

Maren Kettner, Projektmanagerin

Unusual hobby
Dog psychologist

“Communication with your dog“

Learn to communicate with your dog properly and analyse its behaviour. It provides lessons for other areas of life.

The magic formula is understanding behaviour and learning to communicate – two important components that are closely related in a consultant’s professional life as well.

Maren Kettner is a customer-oriented, flexible, patient, enthusiastic consultant, and she brings all these strengths to her hobby of being an animal trainer and psychologist. Maren is what you think of when you talk about capable women. She works as a consultant at Pitzek GMP Consulting and trains “problem” dogs and service dogs in her free time.

“Supposed misbehaviour on the part of the dog is often merely the result of miscommunication between the dog and its owner,” Maren says.

This is comparable to problems that occur at work. A dog psychologist provides specific tips and recommendations for improving trust between dog and owner and improving communication for the long term.

Interview with our colleague, Maren Kettner:

How did you decide to become a dog trainer and dog psychologist?
Lots of people have trouble with their dogs. That bothers me as a dog handler. Some “training methods” I have seen contribute to this problem. Besides, I have always had special issues myself, which is how I got into psychology. I like to use my knowledge and abilities to help dogs and people.

You have a companion dog yourself, and that isn’t altogether usual, is it?
That’s right. Fortunately, there are more and more service dogs. Unfortunately, there are also many trainers who capitalize on people’s distress to enrich themselves – and on top of that, they don’t work in a goal-oriented manner…
Bollernose Melwin, my dog, lets me know if my blood sugar is about to tank. This is an important job, even though I have a sensor – it always runs a bit behind real time – so I often don’t notice in time. My dog is always faster and better than technology! A four-legged life-saver.

So what exactly is the difference between a dog trainer and a dog psychologist?
I think that a good dog trainer is also a psychologist, one that serves both members of the human-dog team. My job is not just to teach the dog to sit, lie down, and heel (that is conditioning, which is what a trainer does), but also to assess the entire team and get them to communicate with each other. I have also encountered many dog owners with all sorts of depression.
In one case, I saved a marriage. The couple had been married for 20 years, and the husband moved out because of one of their three dogs. Fortunately, I didn’t know that until my visit was almost over.😉
Then there was a puppy that the vet had given up on after two weeks on drip feed. Fortunately, the family told me what was going on. As soon as I got off work, I went straight to their house. The husband told me about his wife’s depression and what it would mean if the dog didn’t survive. Bello wore a sweater at home because he was so malnourished that he was cold all the time. After a Reiki treatment, he got up, asked for food and water – and wanted to go outside and play. Today, he’s a very healthy dog. That’s all part of what I do. I could go on and on with examples.

In dog psychology, how do you communicate with a dog?
With body language. Many people have trouble reading body language.
And they often don’t even know what they even want.
And they are not clear in their communication. The dog has to guess what is expected of it and decide for itself whether to comply with the body language or the spoken language.

Why are there so many problem dogs? What’s going wrong?
Most of what’s going wrong is in people’s heads.
And unfortunately, lots goes wrong in animal protection services, too. Just the thought that animal protection services neuters or spays all the animals it gets bothers me.
The problems are endless. I could write a book about it.

What makes you an expert in this field?
My years of experience with dogs. I practically grew up with litters of puppies.
My “psychological studies” on people.
My sensitivity and analytical ability.
My adaptation to each situation and each human-dog team.
My scientific background, including in the medical area.
My ability to work energetically.
The interplay of all these factors.

Is there a generic tip you could give to any dog owner?
Lots of them. One of the most important is to let puppies go up and down stairs.

Summary

Sensitivity and patience are the most important virtues here, and they serve our colleague well at work, too. She meets misunderstandings with calm, structure, and clarity.

News about GMP-World

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GMP CLEANROOMS MUST BE QUALIFIED AND CLEANROOM PROCESSES VALIDATED. THIS QUALIFICATION CONSTITUTES DOCUMENTATION THAT CLEANROOMS ARE SUITABLE FOR THE INTENDED PURPOSE

Cleanroom classes according to the GMP Directive, Annex 1 – new 2020 version!

In pharmacy and the aseptic manufacture of pharmaceuticals, classification according to the GMP Directive Annex 1 is usual. It is imperative that the information in the Directive concerning contamination risk monitoring be adequately observed.

Annex 1 of the EU GMP Directive defines limit values for ambient air particle counts and microbiological contamination by microorganisms.

The revised version of Annex 1 was included in the 2020 release of the 12th version. It makes the absolute necessity of a contamination control strategy clear. This Annex contains the general guidelines to be used for manufacturing all products according to the principles of quality risk management in order to prevent any contamination of the end product.

Overall, there are GMP Cleanroom Classes A, B, C, and D. Class A is the cleanest, while Class D allows the maximum permissible particle concentration.

In order to operate a Class A cleanroom, all the cleanroom classes in between must be complied with and may be skipped over under special conditions only. This means that the cleanroom must first move from D to C, then C to B, and only then can A be conceptualised and implemented.

Class A is necessary for such applications as sterile filling. On the way there, each intervening cleanroom class must normally be complied with in turn and may be skipped over under special conditions only. Personnel and material sluices transition between the cleanroom zones.
Room classification according to GMP (Good Manufacturing Practice) is used in pharmacy, biotechnology, medical technology, and the food and cosmetic industries.

Cleanroom qualification and validation involve comprehensive, high-quality qualifications of all cleanroom equipment and systems according to current directives, including comprehensive, gapless, GMP-compliant documentation. Everything should work together perfectly.

We will actively support you in achieving this goal.

8. Engineering Summit, Networking-Congress, Darmstadtium

We look forward to your visit and to pleasant conversations at our exhibition stand!

Webinar “clean solutions – your advantage”

The path to GMP-compliant automated parts preparation

A GOOD DEED FOR THE REGION – DONATE AND HELP

In 2019, Pitzek GMP Consulting GmbH laid the foundation stone for a planned long-lasting partnership as a regional promoter of social projects of the Lichtblick day community centre in Neustadt an der Weinstraße. In 2021, it is also supporting Lichtblick with a donation amounting to €1.000,–- for its fight against poverty, social indifference and intolerance.

Robin Rothe, the new dedicated head of the institution, explains the social work of the Lichtblick day community centre to the team of Pitzek GMP Consulting GmbH in detail. “It isn’t easy when such institutions are primarily dependent on donations. From part of the donations, full-time staff, who day after day do more than just espouse our aims, also have to be financed”, says Rothe, head of Lichtblick in Neustadt since 1 September 2020.

The full-time staff as well as volunteers do an enormous amount of work every day and it is difficult for outsiders to imagine just how much they actually do. The signs of the times have been set: the clientele is undergoing a transformation, and this is why Lichtblick is fighting against old-age poverty and homelessness more vigorously than ever before. Every day, more than 50 people needing food come to the soup kitchen, at the moment situated in the Casimirianum; that is a lot. As breakfast is free here, many donations for coffee, milk and sugar are needed.

Nevertheless, Lichtblick does not want to complain; it is glad for every donation and all the more so for generous donations amounting to €1,000.- such as the one from Pitzek GMP Consulting in Neustadt an der Weinstraße.

In 2020, the consulting company for the pharmaceutical, food and biotechnology industries therefore decided that, in 2021, it would not give out any Christmas presents or send New Year’s greetings by post, hopefully aiming to encourage its customers and business partners to make a contribution to the region and make a donation of €1,000- to Lichtblick. “Customer satisfaction and the satisfaction of our employees are very important for us and this is why we are naturally hoping for active affirmation of this campaign”, says Dr. Rainer Maué, CEO of Pitzek GMP Consulting.

The donation cheque was handed over on Tuesday, 2.02.2021, in the new rooms of Pitzek GMP Consulting GmbH, Wallgasse 11, Neustadt, of course in compliance with all hygiene requirements.

 

“WORKING FROM HOME AS A PERMANENT CONDITION” HOW MANAGERS CONTINUE TO BE HIGHLY EFFECTIVE TOGETHER WITH THEIR TEAM

A healthy mixture of control and autonomy

Management behaviour that ensures a great deal of freedom, independence, individuality and even autonomy has proven to be especially suitable. Nevertheless, there must also be a strong focus on leadership and task allocation. According to surveys, one excellent approach is a good combination of task-oriented management and a high degree of autonomy for employees.

Task-oriented management (control):

  • Achieving company goals
  • Task supervision

Relationship-oriented management (autonomy)::

  • Self-reliance of team members
  • Cooperation of team members with each other
  • Flexibility
  • A cooperative and supportive work climate

Task-oriented management does not always have to be negative. However, individual workplace autonomy is often restricted. A purely task-oriented management style provides security and a clear structure but the performance of the employees can suffer as a result.

One of the advantages is that leading managers coordinate the tasks and clearly formulate their expectations. According to surveys, this is especially important for employees in a virtual work environment.

DBut the autonomy of the individual employee is also important and is supported above all by a relationship-oriented management style. Managers enable the employees or the team to take the initiative themselves, to learn from their own mistakes and take responsibility for them and to cope with difficult situations in their own way. This not only places demands on employees but also encourages them – and, in the end, this strengthens the cohesion of the team.

Especially in times of the virtual team, the advantages of both should be seen and placed in an appropriate healthy relationship to one’s own corporate structure.

At the end of the day, a healthy mix is always the right recipe, just as it is in real life

Whether your company has already established digital work processes in order to guarantee smooth processes plays a large role in this context. This is because, while digital transformation is already a challenge for a company, the pandemic-related circumstances can quickly cause uncertainty among employees.

“”We can confidently say that we have found the healthy mix and that our digital processes have proven to work at such an early stage, enabling us to build up a fantastic team for fantastic projects”, says CEO of Pitzek GMP Consulting GmbH, Dr. Rainer Maué.

NEVER STAND STILL – BASIC MOTIFS IN NEW CLOTHING

Do you know our Image Spot campaign 2020?
Pitzek is totally enamoured. Find out whether there is such as thing as love at first sight.
Pitzek makes short work of its challenges. Find out whether there is a shorter way.
Pitzek is straightforward. Find out how we do things – no ifs and buts.

In our new key visuals, there is now also a link to our very successful campaign. It will be exciting to see whether you discover parallels to our spots in our online campaign of the specialist Pharma and Food and Pharmind media.

We give you a small foretaste here!

NEWS FROM THE GMP WORLD

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INCREASING REQUIREMENTS FOR THE TRANSFER OF PROCESSES AND TECHNOLOGY IN ACCORDANCE WITH GMP AS WELL AS THE STRONG INFLUENCE ON PROCESS VALIDATION

Transfer of processes and technology is what happens when a pharmaceutical company wants to change from an existing production location to another or when a product that has so far been manufactured on an experimental scale is now to be produced on a larger scale for the market.

There are often reasons to move production to a different location or build up additional capacity. This is usually referred to as a “replication of existing equipment, systems and processes”.

DThat sounds simple but there is a lot more to it. Many factors influence the manufacturing process. This is why quality has to be the main concern when a tech transfer takes place. Critical characteristics of the product must be known and taken into account when technology is transferred.

Technology transfer in the pharmaceutical industry means more than “copy and paste”!

DThe EU GMP guidelines require detailed documentation of transfers, transfer plans and transfer reports, among other things.

This has recently been applied to the transfer of processes and methods in the area of qualification and validation in pharmaceutical manufacturing.

Important points include the following:

  • Qualification status of the original production facility
  • Documentation of the process changes and data changes
  • Process robustness
  • Understanding of processes
  • Clarification of the risks that can arise as a result of a transfer such as cross-
    contamination risks etc.

In the end, this has a great influence on process validation.

Batches produced with changed processes are not included in a stability programme, for example.

Items of equipment are often changed in order to avoid contamination. These changes are insufficiently evaluated or not evaluated at all with regard to the previously validated process and, in some cases, lead to a recall.
In addition, when a change is made, there is a lack of data on new manufacturing processes, whereby such data are needed to confirm the original quality of the pharmaceutical product.

For this, the FDA often requires a comprehensive, independent review of the change management system. The review should encompass the entire change management process.The change management programme should also particularly ensure that changes are taken into account in the stability programme if necessary, that arrangements for qualification and validation work are made and that the effectiveness of changes is determined. The reliability of production must also be assessed.

For this purpose, there are 4 key factors that are also required in order to ensure a successful technology transfer:

  • Packaging line tests
  • Stability indication methods
  • Cleaning validation
  • Health and safety check

For this reason, the validation plan requires that all improvements or changes regarding the design of devices and equipment be described as well as how human error is avoided/eliminated.

These are just a few of the necessary things that have to be taken into account with regard to further manufacturing purposes.

We are happy to advise you on this.

GEOGRAPHICAL PROXIMITY OT THE CUSTOMER

Geographical proximity to companies that are customers is very important in spite of increasing digitisation!

The shortest wayIn the special edition of our January 2021 newsletter, we introduced our new locations with their main contact persons.

Both “mental” and social proximity are important for us in that they enable us to understand your needs and expectations as a customer more completely and work with you in a relationship of mutual trust over the long term. This is because we need to work with each other and not for each other!

Moreover, we are thus able to reduce a simple cost factor for you:
when we are close to you geographically, a large part of the travel and accommodation costs incurred as a result of the need to work with you locally on site will be avoided in future. As a result of these considerations, we opened our north east branch office in Berlin and also our south east subsidiary (Germany/Austria) in Salzburg.

If you haven´t discovered the special edition in January, you will find your direct contact person for the different locations here again.!

Pitzek GMP Consulting GmbH germany on a continuing growth course

New structures, new competences, additional know-how, extensions, branch offices

In April 2020, we had informed you of various extension and restructuring measures carried out in our company.

IIn the course of further developments Joachim Fischer, starting on 1 Sep. 2020, has been dealing with his new challenge as Head of Business Division of the north-east branch in Berlin and will expand the office there further. We are therefore in a good position for our projects in the north and the east and are also closer to you.

Joachim Fischer, Geschäftsfeldleiter Nord/Ost

Mr Fischer possesses comprehensive knowledge of pharmaceutical process engineering and technology. Joachim Fischer joined Pitzek GMP Consulting in 2017 as head of production and the “Sterile Packaging” section and, since then, has been intensely involved in the further development of engineering projects, from concept engineering and commissioning to after sales. Joachim Fischer is thus handing over overall technical management to his colleague Dirk Leutz in Neustadt, who is simultaneously working in his new job as group leader.

Mail: joachim.fischer@pitzek-consulting.de

Contact mobile phone:
Tel.: +49 151 679 492 39

Dirk Leutz, Gesamttechnischer Leiter

After only a short time at Pitzek, Dirk Leutz is taking over the position of overall technical manager and is simultaneously working as group leader. He is therefore one of the main contact persons for all matters relating to pharmaceutical engineering projects.

After his training as a brewer and maltster, Dirk Leutz studied food technology He began his career at Krones AG. It was there that he first had to do with aseptic techniques. After a few stages in his career, he took over as technical and personnel head of a large team and, as departmental manager in international plant construction in the beverages industry in 2019, came on board of Pitzek GMP Consulting GmbH. From the very beginning, he has loved the corporate philosophy of Pitzek GMP Consulting and established himself quickly in the company.

Mail: dirk.leutz@pitzek-consulting.de

Contact mobile phone:
Tel.: +49 151 725 035 84

Eva Boller, Gruppenleiterin

On 1 July 2020, the young employee Eva Boller reached the next rung on her career ladder at Pitzek GMP Consulting and also took over as second group leader.

During her engineering studies relating to biotechnology/biopharmaceutical technology, she was fascinated by machine systems and process technology, and especially the associated areas of qualification and validation. In 2016, she started the second step of her career as a GMP Compliance Engineer at Pitzek and, since then, she has gone straight up the career ladder. Her specialist pharmaceutical studies and her profound knowledge of GMP regulations as well as her knowledge in the areas of qualification and validation make her a GMP expert and the main contact person for our customers in the area of qualification/validation.

Mail: eva.boller@pitzek-consulting.de

Contact mobile phone:
Tel.: +49 151 27006023

OUR NEW STRUCTURE SUBJECT MATTER EXPERTS WILL PACKAGE ADDITIONAL KNOWLEDGE FOR YOU

SPECIAL KNOW-HOW – ULTRA-CLEAN MEDIA PHARMA- & BIOTECH INDUSTRY in germany


NEW COMPETENCES – QMS – Technology transfer – CSV in the Headquarter germany


We´re proud of this!

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Reference project – FDA Readiness of the qualification documents

FDA Readiness der Qualifizierungsdokumente


The customer
From its facility in Wasserburg, Recipharm offers sterile manufacturing capacity in vials and ampoules. The factory is near Munich and is a competence centre for freeze-drying in bottles with highly automated devices, which are the latest state-of-the-art.
With more than 370 employees, the facility also manufactures aseptic vials and ampoules with flexible batch sizes, as well as secondary packaging and other associated services.
The new production building, which was approved by the authorities as possessing GMP conformity in April 2017, is equipped with innovative, fully automatic freeze-drying technology that can be loaded and unloaded on a large scale. This ability, which is unique to Recipharm, means that the team in Wasserburg can offer industry-leading services to its customers.
For over 40 years, the factory has been offering contract services without any batch sterility errors. It has been inspected not only by the supervisory authority of Upper Bavaria and certified to EU-GMP, also for clinical studies material, but also by the FDA, KFDA, TGA, GCC-DR, HPB Canada, ANVISA and TMMDA. The facility has been accredited according to the ISO 14001 environmental management systems, the OHSAS 18001 occupational health and safety management system and the ISO 50001 energy management system.

Our project
In its very first joint project with Recipharm, Wasserburg, Pitzek GMP Consulting GmbH was able to prove its worth. The experts were able to very effectively contribute their many years of GMP experience and qualified know-how in preparation for an FDA audit.
Documents were inspected by means of a GMP compliance check in preparation for an FDA inspection and any questionable issues were identified. All documents of the individual parts/sections of the company were checked with regard to essential elements and the respective elements such as URS, risk analysis, DQ, IQ, PQ, VR, SOPs, training list, log book, preventive/corrective maintenance schedules and much more were evaluated on the basis of criteria shown on the checklists.
Pitzek GMP Consulting then considered the most important issues and dealt with them and discussed them with regard to an impending FDA audit. Moreover, Pitzek GMP Consulting made a record of what questions, comments, unclear issues or need for discussion there were with regard to the impending inspection. Afterwards, it was used by Recipharm, Wasserburg, in a subsequent check as a direct aid and guideline.
Weak points and deficits were detected and analysed and are being dealt with according to their priority. As a result of the expert GMP advice provided by Pitzek GMP Consulting, problem tracking-down activities and rectifications of anomalies will be fully comprehensible for any inspector in future.
The close cooperation with our customer as well as the latter’s exceptionally good organisation and openness left room for lively, often controversially conducted discussions about an issue or the complexity of the task.
Last but not least, Pitzek GMP Consulting GmbH together with Recipharm, Wasserburg, was able to find a very good solution for collaboration during the pandemic. During this phase, documents were provided for editing in a so-called documented exchange procedure.

Quote: Michael Isele, Managing Director, Wasserburger Arzneimittelwerk GmbH – Recipharm:

“Pitzek GMP Consulting proved that we were able to find ways and means to work together reliably and with a great deal of mutual trust, even in such a difficult time, not least because of the perfect electronic tools of both parties.”

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News from the GMP world

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QMS and GMP

Introducing quality management or a quality management system (QMS) is a complex project. What is essential for you to consider?


Why:

  • Effective performance in production
  • Cost savings by means of fewer errors or complaints
  • Better fulfillment of customer requirements
  • Customer satisfaction/customer loyalty
  • Compliance with legal regulations
  • Involvement of the employees
  • Greater employee satisfaction

Which costs:

  • Personnel expenditure
  • External consultants
  • Certification/audit

Important milestones in the project:

  • Quality policy and quality goals
  • Definition of key data/figures
  • Stakeholder analysis and stakeholders
  • Determination of risks and opportunities
  • Creation of the documentation
  • Determination of customer satisfaction
  • Supplier evaluation
  • Definition of quality inspections

Introduction – the most important steps:

  • Clear definition of goals for the QM system
  • Information of the employees regarding introduction of the QM system by the management
  • Time schedule with main points
  • Description of the processes and the documentation by employees
  • Qualifying employees or external support by consultants
  • Monitoring of the project’s progress
  • Project manager ensuring compliance with requirements, standards and regulations
  • Selection of certification company and auditor
  • Date for certification

After successful introduction of the quality management system, it will be improved continuously. Quality management is always ongoing.

Correctly planned, implemented and successfully inspected

During your next preparations for audits and inspections, think about adaptation of altered general conditions, check your manufacturing processes (compliance check) and, above all, check your entire documentation.

We can offer you:

  • Set-up of a QMS in accordance with EU or FDA GMP guidelines
  • Development of standard operating procedures (SOPs)
  • Creation of the QM manual
  • Critical eye on checking of existing processes and of the production procedure
  • Internal and external compliance risks are identified and evaluated
  • Identification and rectification of weak points and deficiencies (gap analysis)
  • Documents are carefully checked and supplemented
  • Processes and documents are made explainable for all involved employees
  • Performance of self-inspections and accompaniment of official inspections

You have questions on the quality management system or are looking for support here. We will be happy to help you personally. 

IT challenges in corona times and successful solutions for customers

“The limitations on our pharmaceutical sales operations due to corona are a special challenge, of course”, admits Dirk Leutz, general technical manager at Pitzek GMP Consulting. “But we also see this as an opportunity to implement digital and innovative alternatives and ways of supplementing personal visits. One advantage is that, digitally, we are already in a very good position.”

Where visits to customers’ offices are not possible, pharmaceutical companies need to take new approaches and rethink their strategies. As far as development is concerned, both will be the case in future. Personal contact will definitely not be dispensed with altogether, it will rather be supplemented with suitable digital tools.

There are particular technical and organisational challenges that we have to face.

At the beginning, we all had to face seemingly insurmountable challenges.

And challenges call for solutions

“Having face to face contact” with our colleagues and customers is important for all of us and we have found digital ways of doing this for some years now, thank God. What’s more, we have also faced up to the technical and organisational challenges and, working with our customers, have developed solutions and strategies in this difficult time. Of course, there are always things that still need to be done but a great deal has already been achieved.
As all employees had to work from home or sometimes from the office in Neustadt, companies mostly have had to find an alternative to the previously usual office workplace, e.g. in the customer’s company. The standard workplace and also the standard work tools no longer existed and it was necessary to adapt to the employees’ circumstances at home and the technical conditions of work there.

Our employees all have highly modern equipment and can digitally gain access to existing infrastructures from anywhere at any time – together with the customer when necessary. Cloud-based working, common share points, video conferences/meetings and a healthy mixture of customer’s company, office Pitzek GMP Consulting and home office created an enormous amount of mutual trust and will also influence our project work in future.

Flexibility and cooperation with partners: Especially in uncertain times, flexibility is a critical but essential factor. Close communication with customers, suppliers, service providers and sales partners is absolutely necessary. Certain issues relating to development, scope of work and required capacities have to be agreed on jointly. In future, personnel can also become a critical factor: lockdown, reduced working hours, quarantine. Depending on the situation, this calls for a high degree of flexibility in collaboration with consultants and service providers.

Interview Pharma & Food “Of necessity up-to-date”

Interview Pharma+Food with CEO Dr. Rainer Maué, Pitzek GMP Consulting GmbH

Rainer Maué, GeschäftsführerReturn of pharma production to Europe on the one hand, growth in South East Asia on the other, and a need for consulting everywhere. In the interview, CEO Dr. Rainer Maué of Pitzek GMP Consulting describes the significance of GMP consulting between worries about the pandemic and internationalisation

 

„There are clearly some great changes underway“


P+F: How has the market changed in the last few years for you as a GMP service provider?
Dr. Rainer Maué: There are clearly some great changes underway: the big industries in the pharmaceutical area used to do everything in-house as far as GMP was concerned and would only work a little with external consultants or service providers. Contract manufacturers or GMP consulting, there has been relatively little of this. Such service providers, however, have gained momentum in the last few years. And I assume this will intensify – also as a result of the corona pandemic.
Moreover, the enquiries we receive from our customers confirm what is also being propagated by the federal government: that “pharma Germany” no longer exists – but that there are efforts to keep back pharmaceutical production in the country or bring it back here. One can sense that the big companies are also thinking more about this. The pandemic also shows that this is a point of focus when it comes to new projects.

„”Fortunately, we changed over the way we work to Cloud access even before the pandemic, this is very helpful during the pandemic.”“

P+F: What services are your customers unable or do not want to perform in-house and therefore call on these services especially?
Maué: For companies, it is almost an impossibility to keep specialist knowledge about the applicable regulations up-to-date in one’s own company at all times because the requirements in the GMP area are increasing faster and faster. Due to the more demanding requirements in the field of pharmaceuticals, the medium-sized companies have necessarily become more open to working with serious consulting companies in order to be able to compete with the giants in the industry………………. ………………“

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Expansion Asia

Pitzek GMP Consulting opens office in Singapore

The pharmaceutical service provider Pitzek GMP Consulting expands into the Asian market. The new subsidiary is located in the heart of downtown Singapore, which is now considered the international hub for the pharmaceutical industry and the medical technology in Southeast Asia (SEA). There are also numerous known pharmaceutical and medical technology business as well as customers of the German business established.



Pitzek GMP Consulting, Neustadt/Weinstrasse, has continuously expanded its presence in the German area. Now with the established representation in Asia, the consulting firm wants to support its globally operating pharmaceutical customers with even more targeted consultancy, qualification and validation, as well as engineering and additional GMP consulting.

“I am excited that we are rising to the new challenge and achieving a milestone in the company history”, said Rico Grosse-Schuette, Managing Director of the new Pitzek GMP Consulting Pre Ltd. in Singapore. He added, “Thanks to our new presence here in Singapore, we are able to be close to our customers, who operate in the tiger states as well as their neighboring countries, and we can now support and take care of them immediately through our specialists. We are very optimistic that the new location in Asia will provide a valuable contribution to the business growth“.

Rico Grosse-Schuette has 20 years of experience in the medical technology and pharmaceutical industry. Most recently, he was the team leader of quality management systems; he got to know qualification & validation from the manufacturing side at Roche Diagnostics International in Switzerland. Grosse-Schuette has been living in Singapore for several years and knows the Asian market, which currently develops rapidly. Singapore offers excellent opportunities for expansion.

ISPE „Aseptic Processing”


Organised in cooperation with ISPE DACH, our workshop in Bad Dürkheim was met with an excellent response. After all, containment is a hot topic in the pharmaceutical industry right now. The growing awareness is driving the technological advancement of containment facilities in pharmaceutical production and laboratories. The time has come to discuss the matter in professional circles.

In view of the importance of process reliability, specific measures are required for working with low occupational exposure limit values and complex toxicological analyses. After all, many of the latest drugs work at even a low dosage, meaning that their ingredients are highly active. What offers opportunities to patients poses a challenge for manufacturers. This is compounded by new regulations such as the extended EU GMP guidelines.

At the two-day workshop in Bad Dürkheim, the team here at Pitzek GMP Consulting worked with ISPE DACH to organise highly successful discussions of these topics. Learning, sharing experiences, discussions and the development of ideas and technologies were all on the agenda. The workshop was quickly fully booked and a follow-up event is already being planned.