Monday, 27 July 2020

Latest draft of EU GMP Annex 1 signals changes for cleanroom management


EU GMP Annex 1 is currently going through a detailed revision process. In February 2020 a new draft was issued, with the final version expected later  this year. The latest revision carries implications for cleanroom design and operations. The draft Annex introduces a new viable count qualification expectation; provides a Grade D particle count ‘at rest’ limit for the first time;  and strengthens personnel controls. This article looks at these changes along with other expectations for cleanrooms and clean air devices.

In relation to this, Tim Sandle has written an article. The reference is:

Sandle, T. (2020) Latest draft of EU GMP Annex 1 signals  changes for cleanroom management, CleanAir and Containment Review, Issue 41: 14-17

Here is an extract:


Considerable time has elapsed between the European Medicines Agency (EMA) issuing drafts of Annex 1 to EU GMP. The first draft (without a version number) was released for widespread public comment on 22nd December 2017  (designated to replace the current Annex, which was last revised in 2008). This draft was subject to widespread public consultation, which resulted in over 6,000 comments being submitted to the EMA. A new draft, numbered version 12, the first indication of changes made in response to the comments has now been issued (on 18th February 2020).  This time around, only specific sections can be commented on and then only by approved professional bodies over the course of three months. The more restricted approach signals that the Annex is close to being locked-down and the finalised version issued. There are, however, a number of changes made to the February 2020 draft compared with the December  2017 version. This article considers those changes which impact upon cleanrooms, clean air devices, and contamination control.

For further details, please contact Tim Sandle

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

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