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QC Chemistry Statistical Trending

Quality SystemsQuality ControlFormSOP

What this document is for

In a current Good Manufacturing Practice (cGMP) environment, maintaining a state of control is a strategic necessity. Statistical trending serves as a proactive quality tool, allowing the laboratory to detect subtle shifts or drifts in process performance before they result in product failure or non-conformance.

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Ships as

Document typeCode
SOPSOP-QMS-022
FormFRM-QMS-026

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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