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.

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”!

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.

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 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.

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

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.

Mail: joachim.fischer@pitzek-consulting.de

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.

Mail: dirk.leutz@pitzek-consulting.de

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.

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

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

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. 

“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.