Annex-16-batch-release-vs-TGA-release-for-supply

PIC/S PE 009-16 update, part 2: New Annex 16 vs Release For Supply

This is the second of a two-part blog covering the changes to PIC/S version 16. Previously we discussed changes to Annex 13 – Manufacture of Investigative Medicinal Products, and today I am doing a comparison of the new Annex 16Certification by the Authorised Person and Batch Release and comparing it against the TGA’s Release for Supply of Medicines guidelines (version 3, published February 2019) to see if there are any gaps that the Australian industry needs to watch out for.

Going through the new Annex 16, I have noticed that the EU GMP Annex 16 Certification by a Qualified Person and Batch Release (EudraLex, Volume 4) has been adapted for PIC/S as part of their continued effort to harmonise international requirements. This annex applies to the batch release of an authorised medicinal product as defined by its Marketing Authorisation (MA) and an investigational medicinal product as defined by its Clinical Trial Authorisation (CTA).

The terms, interpretation and application of PIC/S GMP requirements have been kept equivalent with the EU GMP Guide, for example, the PIC/S term of “Authorised Person” and the EU term of “Qualified Person” are equivalent.

Comparison of PIC/S Annex 16 with TGA’s Release for Supply of Medicines

The table below provides a comparison of the new Annex 16 with the TGA’s Release for Supply of Medicines guidelines:

As a summary, even though terms and viewpoints used by the new included PE009-16 Annex 16 and the TGA Release for Supply of Medicines are slightly different, the overarching process for the release of a batch are comparable.


Back to part 1 – Changes to Annex 13 in PIC/S Guidelines


Annex 16 Compliance Resources

Education resources for PIC/S Annex 16 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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Annex-16-batch-release-vs-TGA-release-for-supply