FDA publishes draft guidance on container closure systems

9th October 2026

Summary: The FDA has published draft guidance addressing the evaluation of container closure systems used to package human drugs and biological products, including relevant combination products. The document provides principles for assessing the quality and suitability of packaging systems and is intended to support consistent regulatory submissions. The guidance is particularly relevant to pharmaceutical manufacturers, quality assurance professionals and those responsible for packaging validation and product quality. The FDA is inviting comments on the draft until 13th October 2026.

Link: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/container-closure-systems-human-drugs-and-biological-products

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