Control and Risk Management of Elemental Impurities

What this document is for

The management of elemental impurities is a strategic necessity centered on patient safety and the integrity of the Pharmaceutical Quality System (PQS).

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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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