On 1-February 2022, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) this week revised its good manufacturing practice (GMP) guide (PE 009-16) to reflect the new EU clinical trials regulation (CTR).
Now 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:
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.
A new Annex 16 on the Certification by the Authorised Person and Batch Release
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.
The revised GMP Guide (PE 009-16), with the revised Annex 13 and the new Annex 16, will enter into force on 1 February 2022.
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