Critical Utilities

Training
This new course is focused on how to be compliant in the design, operation & qualification of critical utilities and how to prove it. It comprises four modules including interactive case studies from real experience. This helps the participants to experience live discussions on compliance topics....
Video
Learning Level: Intermediate - Because of their hidden nature, critical utility systems are vulnerable to non-compliance. With their potential to impact product quality or performance in a significant way, critical...
Video
Regulatory compliance of critical utilities is essential to maintaining overall facility compliance. Due to their hidden nature, critical utilities can become vulnerable to non-compliance and significantly increase the...
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14 July 2020
News & Press Releases
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...
Guidance Docs
The goal of the ISPE Good Practice Guide: Critical Utilities GMP Compliance – How to Be Compliant and Ready to Prove It is 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.
Knowledge
This presentation from the Critical Utilities Community of Practice was given in February of 2017. Conductivity – What is it ? How and why it is...