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:
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)
The following ISPE guides are superseded with this revision:
Purchase the ISPE Baseline® Guide: Commissioning and Qualification (Second Edition) online, among ISPE’s other detailed education resources on a variety of industry topics.