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Management and Execution of Quality Technical Agreements (QTA)

Quality SystemsQuality AssuranceFormSOP

What this document is for

In the highly regulated landscape of pharmaceutical manufacturing, the formalization of quality expectations between parties is a strategic necessity.

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Ships as

Document typeCode
SOPSOP-QMS-014
FormFRM-QMS-016

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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