Annex 2A – Manufacture of ATMPs under GMP PE009-015
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Annex 2A – Manufacture of ATMPs under GMP PE009-015

ByEliza

PE00-015 Guide to Good Manufacturing Practice for Medicinal Products has recently been adopted by the TGA in Australia. Notably, this update separates Annex 2 into advanced therapy medicinal products (ATMP) and biological medicines, as follows: Annex 2A: Manufacture of Advanced Therapy Medicinal Products for Human Use (ATMP) harmonises with the EudraLex Volume 4 Guidelines on…

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

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

ByEliza

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 16 – Certification by the Authorised Person and Batch Release and comparing it against the TGA’s…

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

ByEliza

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…

TGA Medicinal Cannabis
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TGA Medicinal Cannabis

ByTrevor

I’m often asked to clarify the difference between TGA Medicinal Cannabis and EU GMP Medicinal Cannabis, i.e. who is that has the highest “Gold Standard” for Medicinal Cannabis? I suspect this has come about because many are trying to claim that their cannabis is cultivated, harvested and processed in accordance with the strictest pharmaceutical standards…