ISPE Releases ISPE Good Practice Guide: Critical Utilities GMP Compliance

Share Article

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.

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.

About ISPE
The International Society for Pharmaceutical Engineering (ISPE) is the world’s largest not-for-profit association serving its members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical lifecycle. The 18,500 members of ISPE are building solutions in the development and manufacture of safe, effective pharmaceutical and biologic medicines, and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters and training center in North Bethesda, Maryland USA, and its operations center in Tampa, Florida USA. Visit ISPE.org for more information.

For more information, contact:
Amy Henry
Marketing Communications Manager
International Society for Pharmaceutical Engineering (ISPE)
Email: ahenry@ispe.org
ISPE.org

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Amy Henry
ISPE
8139602105
Email >
Visit website

Media

ISPE Good Practice Guide: Critical Utilities GMP Compliance – How to Be Compliant and Ready to Prove It