ABSTRACT
OBJECTIVE: To analyze the key problems in the management of drug production process changes during the drug life cycle, thus to improve the management of pharmaceutical production process changes. METHODS: Taking the change of injection sterilization process as an example, the issues in the study and management of process change were analyzed by employing empirical a-nalysis methods and introducing the concept of equilibrium analysis of the pharmaceutical quality system. RESULTS AND CONCLUSION: The pharmaceutical quality system is the equilibrium system of five aspects, including prescription composition, raw material control, production process, packaging and quality control. Process change research should follow the concept that quality comes from design, use process analytical technologies, and give full consideration to the quality system equilibrium. Process change management needs a systematic management of drugs.