Consideration And Practice On The CMC Quality Control Aspects Of TCM Application

According to the accumulated manufacturing experiences of TCM products, this report proposes that the system of quality specification of combination TCM products should compose three aspects, which are quality indicators, process indicators and overall quality control systems respectively.

The design of quality indicators of combination TCM products consist of safety indicators and efficacy indicators. The concepts of standardized extracts, quantified extracts and other extracts in the EU and multiple batches, multiple doses could also be utilized in the clinical trials to reach the goal of exploring the impact of batch to batch variations on the therapeutic consistency and to provide a reference on the quality control margin.

The research on the process quality indicators of combination TCM products is based on the risk analysis of the manufacturing process. The operational range of the critical process parameters (CPPs) is determined through the research of design space, pre-validation and validation. The batch to batch consistency of TCM products which contain multiple constituents could be improved by the implementation of process analytical technology (PAT) and the establishment of complimentary process control strategy.

Implementation of overall quality control management is the fundamental guarantee of the globalization of the quality control of combination TCM products. The overall quality control management should include several aspects, which include the control of the botanical raw materials, the management of suppliers, the innovation of the manufacturing equipments, the construction and commissioning of engineering projects and multiple validations of manufacturing process and analytical methods etc.