Microbial Monitoring of High Purity Water Systems

What this document is for

The purpose of this Standard Operating Procedure (SOP) is to establish a standardized, validated approach to the microbial testing of critical water systems. Ensuring the microbiological quality of water is maintained within specified limits is essential to prevent product contamination and guarantee patient safety.

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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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