News from GMP world
The new Annex 1 and the effects during sterile product manufacture
About visual inspection
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!
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
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
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:
OUR COLLEAGUE, SABINE HELL-KUNCINGER
Hobby and passion
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.
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
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.
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 email@example.com.
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.
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!
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?
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
OUR COLLEAGUE MAREN KETTNER
“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.
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
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
- 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
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
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.
GEOGRAPHICAL PROXIMITY OT THE CUSTOMER
Geographical proximity to companies that are customers is very important in spite of increasing digitisation!
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.
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.
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.
Contact mobile phone:
Tel.: +49 151 679 492 39
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.
Contact mobile phone:
Tel.: +49 151 725 035 84
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.
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!
Reference project – FDA Readiness of the qualification documents
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.
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.”
News from the GMP world
QMS and GMP
Introducing quality management or a quality management system (QMS) is a complex project. What is essential for you to consider?
- 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
- Personnel expenditure
- External consultants
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.
- 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
„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………………. ………………“
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”
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.