The IPEC-PQG GMP Guide 2022: what’s new and what’s not

Synopsis

The quality of excipients is critical to assure the safety, quality, and efficacy of medicines. The IPEC-PQG GMP Guide is an invaluable tool in helping to achieve a high level of excipient quality and maintain the integrity of the supply chain for the benefit of patients. This important revision presents the latest thinking on good manufacturing practices for excipients, and while the fundamental principles of GMP remain the same, the guide has been revised to align with ISO 9001:2015 requirements. This will be of great benefit to the parties responsible for understanding and complying with GMP for pharmaceutical excipients worldwide.

This presentation will help attendees understand the key changes from the 2017 GMP Guide, the structure of the 2022 GMP Guide, and how to understand and implement the guidance given in the 2022 GMP Guide.