7 March 2022

GMP guide

PIC/S has updated its GMP guide, aligning it with EU requirements to promote harmonization

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has revised GMP Guide to Good Manufacturing Practice for Medicinal Products to include:

  • a revised Annex 13 on the Manufacture of Investigational Medicinal Products (IMP’s) and;
  • a new Annex 16 on the Certification by the Authorised Person and Batch Release

Until now PIC/S had not adapted EU Annex 16, mainly because it was too EU-specific and difficult to implement for PIC/S purposes. PIC/S GMP Guide is namely limited to the manufacture of medicinal products and not to import and distribution. However, after a consultation of the participating PIC/S authorities in 2017, it was agreed to try to transpose EU Annex 16, considering that this could offer added benefit to better convey expectations associated with product release and further international harmonisation efforts in line with PIC/S’ mission to lead the international development, implementation and maintenance of harmonised GMP standards and quality systems of inspectorates in the field of medicinal products. PIC/S has also agreed that elements in Annex 16 related to imported medicinal products would be voluntary, dependent on national law.

Adoption of Annex 16 by PIC/S is also in line with the Co-operation Agreement between PIC/S and European Medicines Agency (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.

All non-EEA Participating Authorities of PIC/S and Applicants have been invited to transpose Annexes 13 and 16 of the PIC/S GMP Guide into their own GMP Guides. PIC/S presently comprises 54 Participating Authorities coming from all over the world (Europe, Africa, America, Asia, and Australasia). It will be interesting to see how these authorities (which include the US FDA as well) approach a possible implementation.