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In the highly regulated environment of drug product manufacturing, the integrity of inspection results is paramount. Test Method Validation (TMV) serves as a strategic cornerstone of Quality Management, ensuring that the analytical and visual tools used to assess product quality are both reliable and consistent.
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| Document type | Code |
|---|---|
| SOP | SOP-QC-039 |
| Form | FRM-QC-040 |
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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