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...
ISPE has published a new Good Practice Guide: Critical Utilities GMP Compliance—How to Be Compliant and Ready to Prove It. Written and reviewed by a team of experts from around the world, the guide is the first of its kind in the industry. Team co-leads Nik Krpan and Rod Freeman talked with...
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...
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...
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.
