PDA TR 54-2

The first Annex to Technical Report No. 54: Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations provides specific case studies on how to apply quality risk management (QRM) to pharmaceutical manufacturing, specifically packaging and labeling operations. This report is intended to align with ICH Q9 and is one in a series of similar documents that provide additional examples of how to apply risk management tools across the product supply chain. Technical Report No. 54-2 was drafted by an all-volunteer team of experts representing companies like Merck, Amgen and Genentech.