Gary Osborn and Steve Hansen
Pharmaceutical Technology JUNE 2002 ISO 9000 and FDA requirements mandate that any measurement be traceable to national standards. Calibration of equipment is necessary to ensure traceability, performance, and reliability.This article explains the proper method for the in situ, on-site, or off-site calibration of lyophilizer pressure gauges and offers some important guidelines to ensure the accuracy of a capacitance manometer.For full article Click Here
validation refers to establishing documented evidence that a process or system, when operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its pre-determined specifications and quality attributes
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Pharmaceutical Validation Documentation Requirements
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