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In a current Good Manufacturing Practice (cGMP) environment, the standardized enumeration of microbial cultures is a strategic necessity. Precise enumeration ensures the integrity of downstream quality control assays by providing a verifiable and consistent concentration of microorganisms.
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| Document type | Code |
|---|---|
| SOP | SOP-QC-018 |
| Form | FRM-QC-021 |
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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