ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Non-Critical Component

A component within a system where the operation, contact, data control, alarm, or failure will have an indirect impact or no impact on the quality of the product.

Publication Source: ISPE Baseline® Guide, Vol. 5: Commissioning and Qualification

Publication Date: 2001

Non-Critical Component

A component within a system where the operation, contact, data control, alarm, or failure will have an indirect impact or no impact on drug quality

Publication Source: ISPE Good Practice Guide: Maintenance

Publication Date: 2009

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