ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Putting a system or systems into operation, knowing inspection, adjustment, regulation, and testing of the system may be less than complete, having first ensured that it is safe and responsible to do so (e.g., the system will not be damaged, or cause damage, or cause death or injury if operated). The purpose of the shake-down is to rapidly reveal and remedy deficiencies prior to commencement of a formal change control regime within a qualification and-or a commissioning effort.

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

Publication Date: 2001

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