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Pharmaceutical Guideline

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121 articles · page 8 of 11

QA

Periodic Review and Requalification

Periodic review and requalification: Periodic review and requalification shall be carried out to ensure the Utilities and equipment should be maintained

QA

Installation Qualification [IQ]

The performance of tests to ensure that the system etc. used in a manufacturing process are appropriately selected and correctly installed.

QA

Site Acceptance Test [SAT]

Site Acceptance Test [SAT] A test conducted at the manufacturer’s site of use, to verify that the system is meets approved specifications.

QA

Design Qualification [DQ]

Design Qualification [DQ] Documented evidence that, for example, the premises, supporting systems, utilities or equipment have been designed for their…