Outstanding! This is my one-word summary for the PDA European Annual Meeting 2018. The second plenary session focused on regulatory progress and the discussion gave some insights into upcoming topics.
In my first article you already read about the plenary session on Pharmaceutical Industry Highlights - Past, Present, Future, and got snapshots of topics presented on 26 and 27 June in Berlin (LOGFILE 27/2018).
This text (and many more) was also published in my live reporting from the conference on LinkedIn(#gmppublishing).
Roberto Conocchia, European Medicines Agency (EMA) and former GMP inspector in Italy, gave an overview of current EMA activities. He focused on the importance of international collaboration that can
Mutual recognition agreements (as with the U.S.A.) are a key element towards achieving the goals. But the FDA will not issue GMP certificates for U.S. sites. A range of GMP guidelines will be updated soon by the GMDP Inspectors Working Group (GMDP IWG) (see picture of Roberto Conocchia’s slide).
Everybody is interested in the Annex 1 progress, but there are no new announcements on this topic. 6200 lines of comments have been received. IWG is working to finalise the text. Roberto Conocchia expects that the final version will be ready by December 2018. Publication should be 2-3 months after finalisation.
The consolidated comments on Annex 1 from the PDA Task Force were proudly presented by Hal Baseman. PDA volunteers did a great job going through the process.
Are there some interesting things besides the aspects we have all heard already?
The PDA is missing the requirements for placement of settling plates in grade A critical areas. Also, more clarification of the intent is expected for methods like aseptic process simulation, airflow visualisation, environment monitoring and personnel qualification.
The PDA recommends replacing specific terms:
He presented also some special comments that should be covered by the final version of Annex 1.
Thank you Hal for this insight into the PDA’s expertise.
Maik Jornitz, GCON Manufacturing, clarified many aspects of PUPSIT. He focused on the technology and process and gave in-depth insight: What happens when the post-use test fails or in the case of non-integrity by filtration? Or - why does a filter fail after sterilisation?
The most common reasons are:
Maik Jornitz described the impact of PUPSIT regulatory requirement on processes. The result: It significantly increases the complexity. The regulatory impact is high and it is highly likely that this requirement is increasing cycle times in manufacturing day-by-day!
You can read the PDA's proposal on that issue in the picture below.
Thank you Maik Jornitz for this great presentation - which ended with a statement everybody should remember in his daily work:
Why should we leave some decisions to the End-User?
Thank you all for this insight into current regulatory topics.
All pictures were made by Jens Liebchen, Copyrights: PDA Europe
Follow us on LinkedIn to learn more about how you can profit from experts in the GMP area: https://lnkd.in/d-YPJsQ
Do you want to stay informed on GMP news and knowledge? Subscribe free of charge to our newsletter: https://lnkd.in/dcQPNTZ
#gmppublishing #pdaeuannual #pda #gmp #gxp
Maas & Peither AG - GMP Publishing