Equipment Hold and Out-of-Service Management

What this document is for

In a current Good Manufacturing Practice (cGMP) environment, the rigorous control of equipment status is a strategic imperative. Effective status management ensures that every asset, room, or system is clearly identified regarding its fitness for use.

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Ships as

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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