Revision of PIC/S GMP Guide (PE 009-15)

About PIC/S

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is a non-binding, informal co-operative arrangement between Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use. It is open to any authority having a comparable GMP inspection system. PIC/S presently comprises 54 Participating Authorities worldwide.

PIC/S aims at harmonising inspection procedures worldwide by developing common standards in the field of GMP and by providing training opportunities to Inspectors. It also aims at facilitating co-operation and networking between competent authorities, regional and international organisations, thus increasing mutual confidence.

Revisions to the PIC/S guide

The PIC/S GMP Guide to Good Manufacturing Practice (GMP) for medicinal products has been revised to include a new Annex 2A and 2B.

  • Annex 2A: Manufacture of Advanced Therapy Medicinal Products for Human Use (ATMP); and
  • Annex 2B: Manufacture of Biological Medicinal Substances and Products for Human Use
Annex 2A
  • It provides PIC/S GMP requirements for ATMP
  • it is not a standalone document but it enables reasonable harmonisation with the standalone ATMP Guidelines published by the European Commission. 
Annex 2B
  • This Annex has had very minor revisions and continues to harmonise with the EU Annex 2 for human use biological medicinal substances and products. 
When will the revised GMP Guide (PE 009-15), with the new Annexes 2A and 2B enter into force?
  • It will enter into force on 1 May 2021.
  • All non-EEA Participating Authorities of PIC/S and Applicants have been invited to transpose the revised Chapters of the PIC/S GMP Guide into their own GMP Guides.

Source: PIC/S website