ISPE Releases Good Practice Guide: Critical Utilities GMP Compliance

ISPE has 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’ GMP compliance to regulatory inspectors and auditors. Key areas addressed in the Guide include:

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

In the words of Nik Krpan, President, Cheme Engineering, and Guide co-lead, “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. 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.”

To purchase the guide, click here: ISPE Good Practice Guide: Critical Utilities GMP Compliance – How to Be Compliant and Ready to Prove It. (Source: ISPE Website, 14 July, 2020)