LOGFILE No. 33/2018 – Regulatory Update at the PDA European Annual Meeting
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).
EMA Regulatory Update - Annex 1 in March 2019?
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
- maximise inspection resources,
- focus on highest risk,
- minimise duplicates and
- broaden inspection coverage.
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.
Anything new on the Annex 1 planet?
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:
- Laminar air flow —> unidirectional air flow
- Non-viable particulates —> total particulates
- Alert/action limits —> alert/action levels
- Grade A/B/C/D —> ISO 5/6/7/8
- Contamination (concept) —> contamination control strategy (concept)
- SAL or sterility assurance level —> PNSU or probability of a non-sterile unit
- And don’t use ”Clean Not Classified (CNC)”
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.
Sterilizing Liquid Gold or Pre-Use Post-Sterilization Integrity Testing - an update on PUPSIT
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:
- Ignorance of filter manufacturer‘s technical specifications
- Improper end-user training
- Improper sterilisation process design and/or qualification (temperature, pressure)
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?
- Because they know their processes best
- Because they run existing processes successfully and reliably
- Because they know a risk when they see a risk and PUPSIT may be considered a risk
- Because they care about the one person they work for ... the patient!
Thank you all for this insight into current regulatory topics.
Links to the posts:
PDA European Annual Meeting - EMA Regulatory Update - Annex 1 in March 2019?
PDA European Annual Meeting - Anything new on the Annex 1 planet?
All pictures were made by Jens Liebchen, Copyrights: PDA Europe
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LOGFILE-33-PDA-Europe-Part2.pdf
Author:
Thomas Peither
Executive Editor
Maas & Peither AG - GMP Publishing
E-Mail: thomas.peither@gmp-publishing.com
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