PDA TR 58

PDA Technical Report No. 58: Risk Management for Temperature-Controlled Distribution is meant to complement ICH Q9: Quality Risk Management, and is part of the series of good distribution technical reports produced by the PDA Pharmaceutical Cold Chain Interest Group, which has developed Technical Reports No. 39 (Cold Chain), 46 (Last Mile), 52 (GDPs) and 53 (Stability Testing). The goals of risk management in the temperature-controlled distribution of pharmaceutical products, are to:

• Preserve the quality, safety and efficacy of the product
• Understand the distribution process
• Reduce risk
• Understand residual risk
• Improve the effectiveness of the process

Technical Report No. 58 provides specific guidance on the identification, assessment, evaluation, control and review of risks in the distribution process, such as receipt, storage, handling and shipping of bulk, intermediate and finished pharmaceuticals, biological medicinal products and medical devices. It also provides guidance for handling incidents, like temperature excursions, that occur during the distribution process. The Appendix includes examples of five executed FMEAs for the distribution of products in temperature-controlled containers and thermal packouts and a description of Incoterm definitions.