Revision of PIC/S GMP Guide (PE 009-16)

 

The PIC/S GMP Guide to Good Manufacturing Practice (GMP) for Medicinal Products has been revised to include:

 

·         A revised Annex 13 on the Manufacture of Investigational Medicinal Products; and

·         A new Annex 16 on the Certification by the Authorised Person and Batch Release.

 

PIC/S Annex 13 has been revised based on EC Regulation No. 536/2014 on Clinical Trials, which will replace EU Annex 13. This is in line with the Co-operation Agreement between PIC/S and EMA, which provides that the PIC/S and EU GMP Guides should be harmonised with the aim of keeping GMP standards equivalent, thus facilitating the exchange and use of information concerning the manufacture of medicinal products.

 

 

PIC/S Annex 16 is a new annex to the PIC/S GMP Guide. Historically, PIC/S did not adapt EU Annex 16, when it was adopted as part of the EU GMP Guide. Initially, PIC/S considered this annex to be EU-specific and difficult to transpose for PIC/S purposes, in particular since the PIC/S GMP Guide is limited to the manufacture of medicinal products and not to import and distribution.

 

See: https://picscheme.org/en/news/revision-of-pics-gmp-guide-pe-009-16

 

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