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PIC/S PE 009-16 update, Part 1 – changes to Annex 13

Historically, the PIC/S GMP Guide has chapters and annexes revised, aligned and corrected to close the gap between the international GMP guidelines and to further develop and harmonise GMP standards. PIC/S PE 009-16 (or version 16) of the Guide, recently entered into force on the 1st February 2022, and includes changes to Annex 13 “Manufacture of Investigational Medicinal Products” and the inclusion of Annex 16 “Certification by the Authorised Person and Batch Release.”

Starting from this point, is it up to each member or non-member authorities of PIC/S to adapt the new annexes into their own GMP Guides.

Because we have a lot to cover, this blog will be a 2-part series. This blog (Part 1) covers Annex 13, while Part 2 covers Annex 16.


Changes to Annex 13: Manufacture of Investigational Medicinal Products

The changes to Annex 13 were implemented based on EC Regulation No. 536/2014 on Clinical Trials which replaces EU Annex 13. As a general overview, I find the changes to Annex 13 positive; it has a better structure, is less ambiguous with its requirements, and is also more consistent with conventional good manufacturing practice principles.

As an aside – while going through individual chapters, I have noticed there are frequent recommendations for Part 1 or Annexes 1.11, 15 and the new Annex 16 of the PIC/S GMP Guide to be used as guidance.

There are some instances for which PIC/S Annex 13 does not apply:

  • Activities performed outside the authorised manufacturer.
    • These activities are not left outside the review, with clear instructions being provided on measures to be taken for specific situations.
  • The reconstitution process of investigational medicinal products is not generally considered manufacturing (unless subject to national laws).

Now some details of the changes to PIC/S Annex 13:

Read part 2 – Changes to Annex 16: Certification by the Authorised Person and Batch Release!

Education resources for PIC/S Annex 13 and related guidelines:

List of public GMP training courses (Zoom-based) or onsite sessions for large groups of employees

Training presentation for compliance with PIC/S Annex 13 requirements (PIC/S V16 – PE 009-16) 

Training presentation for compliance with PIC/S Annex 16 requirements (PIC/S V16 – PE 009-16)

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