Good Practice Guide: Investigational Medicinal Product Reverse Logistics PDF

Most current reverse logistics processes lack effective planning, thorough application of risk management, and well-defined roles and responsibilities. This results in inefficient and costly processes that often cause delays in study closure as failure to account for study materials can affect the acceptability of trial data. Establishing better standards is also complicated by gaps in and lack of harmonization between Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), local environmental laws and regulations, and import/export and customs regulations. The first such guidance in the pharmaceutical industry, this ISPE Good Practice Guide: Investigational Medicinal Product Reverse Logistics – Good Returns and Reconciliation Practices describes steps that can be taken to plan for and implement a successful reverse logistics process within any investigational product supply chain. It provides a clear outline of the aspects to consider to effectively manage investigational product returns. Written by top experts in the field, the Guide discusses the key requirements of a good reverse logistics process and common pitfalls to avoid.