EU GMP Annex 1 – time to comment

The European Medicines Agency (EMA) has issued a concept paper in which it is recommended to revise the current annex 1 of the European GMP Guidelines, on the manufacture of sterile products. A public consultation is now under way on this concept paper, with a deadline of 31 March 2015.

Key proposals include:

• 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.
• Revision to the Ph.Eur. monograph on methods other than distillation for the production of water for injection.
• Broaden the scope beyond sterile products since guidance on the conditions of the manufacture of some non-sterile finished products and the early stages in the manufacture of a range of products is important.
• To encourage the use of new technologies to protect sterile products (the proposal states: “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.”) 

In terms of when the guide is likely to come out, the timetable is: 

• 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

The document can be found here.

Posted by Tim Sandle