ISPE Releases ISPE Baseline Guide: Commissioning and Qualification Second Edition

01 July, 2019
ISPE Baseline Guide: Commissioning and Qualification Second Edition

ISPE announced the release of their latest guide, ISPE Baseline® Guide: Commissioning and Qualification (Second Edition). This Guide provides practical guidance on the implementation of a science and risk-based approach for the commissioning and qualification (C&Q) of pharmaceutical manufacturing facilities, systems, utilities, and equipment to demonstrate that they are suitable for the intended purpose.

Key topics discussed that are essential to an integrated C&Q effort include:

  • How to apply Quality Risk Management to C&Q
  • Best practices for User Requirements Specification, Design Review, Design Qualification, and acceptance and release
  • Efficient use of a change management process to support C&Q
  • Good Engineering Practice documentation standards

This revision of the Guide simplifies and improves the C&Q process for the pharmaceutical industry by bringing the best of the best together into one document—combining concepts from global regulatory agencies, such as FDA, European Medicines Agency (EMA), and International Organization for Standardization (ISO)

Robert J. Myers
Director of Global Engineering
Pfizer

The following ISPE guides are superseded with this revision:

  • ISPE Baseline® Guide: Volume 5 – Commissioning and Qualification (First Edition)
  • ISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment
  • ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification

Purchase the ISPE Baseline® Guide: Commissioning and Qualification (Second Edition) online, among ISPE’s other detailed education resources on a variety of industry topics.

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