Dear PQ Team - please see below for likely a highly relevant guidance for PQ.
FDA has published a draft guidance for industry titled "Container Closure Systems for Human Drugs and Biological Products" for public comment (posted 14 August 2026). The comment deadline is 13 October 2026. The Federal Register notice is here: Container Closure Systems for Human Drugs and Biological Products (91 FR 52700, 14 August 2026; Docket No. FDA-2026-D-7957). The draft guidance itself is at https://www.fda.gov/media/194220/download.
It touches topics across several communities:
* Pharmaceutical quality and CMC - the risk-based framework itself, packaging material and component controls, tests and acceptance criteria, and what belongs in the application versus the quality system
* Extractables and leachables - the deferral of E/L and toxicological risk assessment to a future guidance, and whether the general framework is workable without it
My analysis is this will definitely be relevant for this team. However I wanted to ask the PQ community:
1) Is this draft relevant to PQ community, and if so,
2) Who here can volunteer as an SME to help draft the response? Combination Products, Extractables/leachables experts may be helpful.
Please respond or email Joe at [email protected].
Best,
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Joseph Thomas
Quality Intelligence and Advocacy Lead
Sanofi
Bolton MA
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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