PDA Technical Report No. 54-3

PDA Technical Report No. 54-3 (TR 54-3) Provides specific case study examples of how to apply quality risk management to the manufacturing of pharmaceutical drug products. These case studies were chosen by the technical report team, of this supplemental annex to PDA Technical Report No. 54, Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations, to illustrate the adaptability of quality risk management tools to help solve various problems, implement corrective actions, and keep processes in a state of control.