Sunday, 28 January 2018

New Guidance for Sterile Products Manufacture is Coming: Review of EU GMP Annex 1

The importance of the new Annex 1 draft is that it not only signals changes in approach from European regulators around the safeguards needed for sterile products manufacture, it further signals a new global direction given that the FDA took part in the document review through the PIC/S convention.

Tim Sandle has written an article examining the main changes and to discuss the implications for those involved with sterile products manufacture.

There are four broad areas of change to the draft, in terms of tone and emphasis. These are reflected at various intervals in the document (often through repeated occurrences). These areas are:

  1. The global acceptance and implementation of ICH Q9 (Quality Risk Management) 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.
  2. 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.
  3. There was some ambiguity with the current version and these needed correction or clarification
  4. Annex 1 is often beyond sterile manufacturing, including aspects of non-sterile manufacturing. The scope of the new draft has been modified and broadened to reflect this.
The purpose of this article is to review the primary changes, in relation to these broad themes, and to better understand the new paradigm for sterile drug products manufacture. This will be helpful for those wishing to comment on the draft and to those seeking to prepare for the using of the final document (anticipated to be later in 2018), since many of the key concepts are unlikely to change.

The reference is:

Sandle, T. (2018) New Guidance for Sterile Products Manufacture is Coming: Review of EU GMP Annex 1, Journal of GxP Compliance, 22 (1): 1-10 (

Posted by Dr. Tim Sandle

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