Sunday, 5 July 2020

EU GMP Annex 1: What The ‘Final’ Draft Reveals


This paper reviews the new of EU GMP Annex 1 draft. In doing so the focus is on those aspects that are different to the 2017 draft, rather than spending much time comparing the 2020 draft with the current Annex 1 (which is dated 2009). 

Readers wishing to do this can refer to the 2018 Journal of GxP Compliance review. The reader should note that this paper contains some personal commentary at different points, either in praise of some of the updates or raising concerns about things that have not been changed which should have or with reference to some of the new things that have been added. 

Of course, the reader may not agree but the change is highlighted some that due consideration can be given.

The core focus with the revision is:


  • The global acceptance and implementation of ICH Q9 (Quality Risk Management) (8) and Q10 (Pharmaceutical Quality System), is not reflected in the current Annex. The new draft contains many references to Quality Risk Management (QRM) in particular, emphasizing that QRM should be used as a proactive tool. There are now 92 instances of the word “risk” in the new draft, an increase from 20 in the previous version.
  • There have been advances in sterile manufacturing technology, especially with RABS and isolators. There have also been advances with rapid microbiological methods, which the draft Annex acknowledges.
  • There was some ambiguity with the current version and these needed correction or clarification
  • Annex 1 is often beyond sterile manufacturing, including aspects of non-sterile manufacturing. The scope of the new draft has been modified to reflect this.
  • There is the requirement for a formal, holistic contamination control strategy (which is now abbreviated to ‘CCS’ in the new draft). The expectation now appears to be for a formal document which reflects the site-wide strategy for minimizing contamination control with respect to sterile manufacturing. The requirements of the contamination control strategy have been widened (43 mentions, up from 19 in the 2017 draft), however, with the new draft, extending to the need to fully-understand and review design, procedural, technical and organizational controls. With the term ‘contamination’ it remains that contamination is used too broadly, and it would be useful if, for example, there was a specific microbiological concern that the nature of the contamination is referred to directly. 


The reference is:

Sandle, T. (2020) EU GMP Annex 1: What The ‘Final’ Draft Reveals, Journal of GxP Compliance, 24 92), at: https://www.ivtnetwork.com/article/eu-gmp-annex-1-what-%E2%80%98final%E2%80%99-draft-reveals

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

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