c and q lifecycle pharmaceutical industry no deviation

Defining Requirements in the C&Q Lifecycle

The ISPE Baseline Guide Volume 5: Commissioning and Qualification Second Edition proposes an integrated C&Q approach that aims to make the C&Q process compliant, efficient, and cost-effective. The key facets of this approach are as follows: Using a System Risk Assessment (SRA) to identify Critical Design Elements (CDEs) that need to be qualified Using properly…

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