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Steve Wisniewski

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Release of 2nd Edition ISPE Baseline Guide 5 for Commissioning and Qualification

By Steve Wisniewski, July 16, 2019

Intro

ISPE has just released the second edition of Baseline Guide 5 for Commissioning and Qualification (C&Q) The objective of the 2019 C&Q Baseline Guide revision is to define and explain a simplified risk-based C&Q process in a single guide that meets present-day standards and provide focus to ensure a compliant, efficient, and cost-effective approach.  The revised Guide provides the current industry best practices for commissioning and qualification of pharmaceutical facilities and equipment.  It supersedes the 2001 publication and the two 2011 Guides covering Quality Risk Management/ASTM E2500 based approaches.

The new Guide provides an improved QRM C&Q process flow and recommended implementation practices with practical examples taken from the industry.

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