Chapter 25 – Clinical Supplies Manufacture: Strategy, Good Manufacturing Process Considerations, and Cleaning Validation

Publisher Summary Pharmaceutical manufacturers often rely on various strategies to help keep their new drug pipeline flowing freely. Effective management of clinical supplies delivery prevents it from becoming a rate-limiting step in product development, reduces the time for a new drug going through clinical trials, and ultimately increases the speed to bring a new drug to market. An implementation of clinical plan, clinical supplies liaison, a lean manufacturing approach, a cross-functional training program for workers, outsourcing, the use of new technology including modern computer technology and new methodologies in drug discovery and development, and process analytical technology (PAT) are among various strategies that can be used to improve clinical trial management. This chapter discusses the current good manufacturing process (cGMP) considerations to ensure the quality of the clinical materials during the clinical supplies manufacture. The comprehensive clinical supply manufacture strategy and cGMP controls prevent clinical supplies manufacture from becoming the bottleneck of a clinical trial program, and consequently reduce the total cycle time of introducing a new drug to the market. There are certain components involved in any method validation activity are outlined in the International Conference on Harmonization (ICH) guidelines on Analytical methods Q2A. For a quantitative impurity test, validation is required for specificity, limits of detection and quantitation, linearity, accuracy, precision, and range.