Raw Material Control and Risk Management

What this document is for

In the highly regulated landscape of Current Good Manufacturing Practices (cGMP), the integrity of a finished drug product or medical device is inextricably linked to the quality and consistency of its input materials.

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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.

Other Drug Substance documents

• Quality Control Analysis of Chemical Raw Materials
• Raw Material Sampling (Working Template)
• Raw Material Sampling Record
• Standard Operating Procedure for Capillary Viscometer Analysis of Drug Product Liquids