Identification and Handling of Suspect and Illegitimate Drug Product

What this document is for

Context & Strategic Importance In the complex global pharmaceutical landscape, maintaining the integrity of the supply chain is a critical safeguard for patient safety. This Standard Operating Procedure (SOP) establishes a robust framework for the identification and handling of drug products that may be compromised.

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Ships as

Grounded in

FDA 21 CFR 210/211 and Part 11, EU GMP (EudraLex Volume 4, including Annex 1 and Annex 11), ICH Q7–Q12, and WHO GMP. Supplied in 13 languages.

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