Thomas Peither

Every pharmaceutical manufacturer must ensure that the responsible employees are informed about current changes and new requirements. This means that resources must be available. They should check the publications of the relevant authorities at close intervals and keep an eye on them. There are more than 50 public authority websites that need to be checked regularly.

5 min. reading time | by Thomas Peither

In September 2020 the series of virtual autumn conferences of PDA and ISPE started. We were present and pick out some excellent sessions with this LOGFILE feature.

Were you able to follow the PDA Annual Meeting of the Parenteral Drug Association this year? Or were you like many others who spent the whole day with web meetings and have no time or mood for more online conferences?

The inspection is carried out in the front office and prepared in the back office. The preparation room is used to train and instruct staff.

A CAPA system should be understood as an important element of the pharmaceutical quality system and implemented uniformly throughout the company or group. In principle, it can be implemented in two different ways: as an autonomous or as an integrated system.

The question "How does process validation differentiate itself from other elements of quality management?" is not easy to answer, because there is still no uniform and generally applicable definition for validation. On the contrary, the term is becoming increasingly blurred with the related technical terms qualification and verification.

A definition of the term “qualification master plan (QMP)“ is not to be found in the GMP guidelines, only the term “validation master plan (VMP)”, which serves as a parent document.

Standards such as those in the DIN EN ISO series are not laws, so they differ quite fundamentally from legally binding regulations. Good Manufacturing Practice (GMP), on the other hand, is laid down in laws, regulations and guidelines.

In this feature we take look at the ‘black sheep’ of pharmaceutical production. As cute and charming as they may be in the animal world, in the world of GMP they can be rather disturbing.

You know the sustainability goals in your company, such as achieving CO₂ neutrality by 2030 or 2050. But what does that have to do with GMP?

Adequate size and lighting of all areas where medicinal products, starting materials and packaging materials are stored is essential for the proper performance of operations.

Subjectivity in QRM should be addressed in every organisation. I had the opportunity to attend a very stimulating presentation by Alex Viehmann, Division Director at OPQ, CDER, U.S. FDA, who shared insights into the new ICH Q9 Guideline on Quality Risk Management (QRM) at the PDA/FDA Joint Regulatory Conference 2023, 18-20 September in Washington.

‘Hygiene programmes adapted to the activities to be carried out shall be established and observed. These programmes shall, in particular, include procedures relating to health, hygiene practice and clothing of personnel.‘ This is explicitly stated in the EU GMP Directive 2017/1572.

The stability of a medicinal product or an active substance is defined as the maintenance of certain quality characteristics (specification) over a fixed period of time under defined conditions.

The life cycle approach to cleaning validation simply means that control of cleaning effectiveness must be maintained on an ongoing basis.

The pace of digitalisation is accelerating. And it is presenting us with new opportunities at ever shorter intervals. This means that all GMP professionals need to be informed and make risk-based decisions! This also applies to data storage in the cloud. What are the opportunities and risks? Which cloud and service models exist? 
In today’s feature, GMP expert Thomas Peither summarises the key points.

Ensuring a clean production environment – sounds simple enough.However, in the pharmaceutical context, cleanliness and contamination are clearly defined, delineated and, of course, regulated, particularly in the manufacture of active ingredients and medicinal products.

Thomas Peither started his GMP journey nearly three decades ago. Throughout this period, he gained an in-depth understanding of the inner workings of GMP in the pharmaceutical sector. Now Thomas Peither – one of the founders of the GMP-Verlag – has stepped down from the board while still maintaining his role as a writer for the publishing house. Today's editorial offers his personal view on the development of GMP, highlighting important shifts and obstacles. He emphasizes the significance of employees in achieving GMP compliance and reflects on why his enthusiasm and confidence in GMP remains unwavering after 30 years.

Empty shelves, incorrectly sorted goods and food that has passed its sell-by-date. A supermarket with such problems would have no chance of success. Materials management would have failed across the board. Fortunately, this scenario is rather unlikely. However, it illustrates the importance of efficient and reliable processes to ensure that the right material from the right source arrives at the right place in the right packaging and under the right storage conditions. The same holds true for pharmaceutical operations. Read more about the key requirements for material storage and internal logistics in this week’s brief extract.