Bridging the Communication Gap Between Critical Utilities & Regulators: NEW ISPE Critical Utilities GMP Compliance Guide

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 utilities consistently receive close scrutiny by regulatory inspectors. 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.

In this webinar, Fritz Roeder and Nik Krpan will give insights on the recent GMP changes, GMP developments and give an overview of the new guide. They will share new topics that have never been described in an ISPE Guide before.

Learning Objectives

  1. Assess the operational readiness of your utility systems
  2. Learn best practices for GMP compliance in water, steam & gas systems
  3. Tips for achieving inspection readiness


Good Practice Guide: Critical Utilities GMP Compliance


Fritz Roeder
Senior QA Manager
Merck Healthcare KGaA
Nikola D. Krpan
Cheme Engineering Inc.