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Environmental Monitoring Program and Cleanroom Standards

EH&SQuality ControlFormSOP

What this document is for

The implementation of a robust Environmental Monitoring (EM) program is a fundamental requirement for maintaining the integrity of a cGMP manufacturing environment.

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Ships as

Document typeCode
SOPSOP-EHS-003
FormFRM-EHS-003

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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