Sterility Method Suitability and Microbial Challenge

What this document is for

The primary objective of this Standard Operating Procedure (SOP) is to establish a formal process for conducting microbial challenge tests on specific articles to ensure the sterility test method does not produce false negative results due to a product’s inherent antimicrobial properties.

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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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