Thursday, 06 August 2020


ISPE releases "ISPE Good Practice Guide: Critical Utilities GMP Compliance" guide

16 July 2020 | News

A useful guide for critical utility professionals and smaller manufacturing facilities to improvise compliance departments

Photo Credit: ISPE.org

Photo Credit: ISPE.org

The International Society for Pharmaceutical Engineering (ISPE) announced the release of its latest guide, ISPE Good Practice Guide: Critical Utilities GMP Compliance – How to Be Compliant and Ready to Prove It. The Guide was cultivated by leading experts to help pharmaceutical organizations achieve and maintain their critical utility systems in a state of control, and then be able to efficiently demonstrate their systems’ Good Manufacturing Practice (GMP) compliance to regulatory inspectors and auditors.

“This Guide will be a big benefit to critical utility professionals and smaller manufacturing facilities where they don’t have as much bench depth in their compliance departments,” said Nik Krpan, President, Cheme Engineering, Guide co-lead. “This resource will help them to identify what are the critical areas they should be focusing on to achieve compliance for their critical utilities and how to host a more efficient audit.” 

Key areas addressed in the Guide include:

  • Water systems
  • Pure steam
  • Compressed air
  • Medical gases
  • Processes unique to critical utilities

Purchase the ISPE Good Practice Guide: Critical Utilities GMP Compliance – How to Be Compliant and Ready to Prove It online, available at ISPE.org/Publications/Guidance-Documents, among ISPE’s other detailed education resources on a variety of industry topics. 


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