Report – Seminar Series 2020 – Seminar New Annex 1 draft “ Barrier and their requirements” with Richard Denk (SKAN AG)

On June 23, 2020 the first seminar of the “Seminar Series 2020” took place on the topic “New Annex 1 draft – Barrier and their requirements” – presented by Richard Denk (SKAN AG) and organized by ISPE SC TU Munich in cooperation with ISPE DACH YP & S.

The Annex 1 of the EU Good Manufacturing Practice (GMP) Guideline deals with the manufacturing of sterile medicinal products. Since early 2020 the new draft of the Directorate for Health and Food Safety of the European Commission is open for stakeholders (such as the ISPE) for further consultation and commentating. The outcome of the commentary phase is of global importance through the cooperation of international organizations such as the World Health Organization (WHO) and Pharmaceutical Inspection Co-operation Scheme (PIC / S).

After a brief introduction to ISPE and ISPE DACH YP & S by Robin Schiemer, Richard Denk guided through the new draft of the Annex 1.
In addition to the distinction between Restricted Access Barrier Systems (RABS) and isolators as well as the importance of Quality Risk Management (QRM), Richard Denk commented various aspects of the Contamination Control Strategy (CCS). Here the main topics discussed were automation and digitization, aseptic equipment design, cross contamination as well as sterility and surface decontamination. The audience was thereby not only presented with the regulatory requirements of the new draft, but also with numerous practical implementation examples.

The one-hour seminar then ended with a Q&A session including the participants.

With more than 100 international participants from industry and academia, the start of the four-part seminar series was a complete success. Which is also reflected in the predominantly positive evaluation of the seminar.
The topic of the seminar seems to have been of high interest, as the topic requests for future seminars are aimed almost exclusively at the content of the Annex 1 of the GMP Guideline.