PDA TR 54-5

PDA's Technical Report No. 54-5, Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems provides practical guidance on how to manage quality risks throughout the manufacturing system lifecycle and illustrates concepts through two case studies. The information in this technical report is applicable to both new and existing manufacturing systems used in clinical, commercial manufacturing, drug substance (API), drug product, packaging and warehousing and critical utility systems. It focuses on manufacturing systems, which can potentially impact product quality.