ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Precedes Regulation and Adjustment, and includes the necessary calibration and preliminary adjustment of instruments, sensors and mechanisms before initial energizing of systems. Prerequisites are satisfactory Inspection, safety/start-up procedures in-place, training given and documented start-up sequences provided. The first stages of setting-to-work can be considered a “shake-down” of the system.

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

Publication Date: 2001

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