European Medicinal Agency (EMA) released concept paper on revision of GMP guidelines for sterile product manufacturers

EMA prepared a draft concept paper for revision of Annex 1 which gives GMP guideline for the manufacturers of sterile medicinal product. The concept paper is released on February, 2015 for comments. Annex 1 guideline is common to the Member States of the European Union/European Economic Area as well as to the participating authorities of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). Since Annex 1 was published no consequential regulatory changes and technological advancements are reflected in these guidelines. Original guidelines were partially revised in 2007. However there have been significant changes in technologies and in GMP following the adoption of the ICH Q9 and Q10 guidelines since then. 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.

According to EMA Annex 1 is being revised:

  • To facilitate the implementation of the principles in ICH Q9 and Q10
  • To extend the underlying concepts to include new areas of technology and processing not previously covered
  •  To correct the inaccuracies and offer more detail to remove ambiguity and to give clearer interpretation of GMP expectations

EMA proposed timeline for Annex revision:

Deadline for comments on released concept paper: March 2015

Discussion in Pharmaceutical Inspection Co-operation Scheme (PIC/S): Committee – May 2015

Discussion in GMP Inspector Working Group (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

You can view the full concept paper Click here