EU GMP Annexure -1 (Manufacture of sterile medicinal products) is ‘all set’ for revision

EU GMP Annexure -1 (Manufacture of sterile medicinal products) is ‘all set’ for revision

Annex 1, the primary GMP guidance on sterile manufacturing for Europe and PIC/S member countries is ‘ all set’ for revision . The original version was partially revised in 1996, 2003 and 2007. Proposed date for release of draft guideline is October 2015.

The current annex 1 will be revised to facilitate implementation of the principles in the ICH guidelines and to extend the underlying concepts to include new areas of technology and processing not previously covered and also to clarify areas that have been highlighted as ambiguous due to the age of the document.

The revised guideline will clarify to what extent Q9 and Q10 should be followed in the design and implementation of facilities, equipment and processes for the manufacture of sterile medicinal products. Other changes that may require new GMP guidance include those for the revision to the Ph.Eur. monograph on methods other than distillation for the production of water for injection.

The current guideline does not reflect the advances in the manufacture of sterile medicinal products; the revised guideline will embrace the use of new technologies

to prevent detrimental impact on product and also to encourage the introduction of new technologies that are not currently covered. The current guideline contains historical inaccuracies and areas of ambiguity, the revised guideline will correct the inaccuracies and offer more detail to remove ambiguity and to give clearer interpretation of GMP expectations.

Proposed timetable

Preparation of draft concept paper - September 2014

Approval of draft concept paper - October 2014

Released for consultation – February 2015

Deadline for comments – March 2015

Discussion in PIC/S Committee – May 2015

Discussion in GMDP IWG - June 2015

Discussion with other Working Parties - June 2015 – September 2015

Proposed date for release of draft guideline - October 2015

Deadline for comments - April 2016

Re - discussion in GMDP IWG - June 2016

Re - discussion in PIC/S Committee – July 2016