Abstract:
OBJECTIVE To put forward suggestions on scientific supervision of pharmaceutical packaging materials by analyzing the current situation of quality control of pharmaceutical packaging materials.
METHODS Summarized and sorted out the development of pharmaceutical packaging materials in China and the development process of pharmaceutical packaging material regulatory regulations in the past 40 years, investigated the quality control status of 84 pharmaceutical packaging material production and use enterprises in the Yangtze River Delta region and analyzes them, compared and studied relevant international regulatory models and concepts. RESTULTS The new regulatory of drug packaging material was still in its early stages in China, and there were still some unresolved issues, mainly in terms of the improving, understanding and implementing regulatory regulations and standards, enterprise inspection and research capabilities, and there were still some shortcomings compared to foreign countries. CONCLUTION Under the new regulatory requirements and development situation, based on the characteristics of pharmaceutical packaging materials, it is recommended to summarize experience and practices, learn from advanced foreign concepts, and explore more regulatory strategies in institutional improvement, platform optimization, standard construction, daily supervision, and increased policy promotion and training guidance to improve the quality control level of pharmaceutical packaging materials and ensure drug safety.