Article 52 of the "Pharmaceutical Administration Law of the People's Republic of China" stipulates: "Packaging materials and containers that are in direct contact with drugs must meet medicinal requirements and safety standards." The management measures, product catalogues, and medicinal requirements and standards for the packaging materials and containers of drugs shall be formulated and announced by the drug regulatory department of the State Council. 113 standards for pharmaceutical packaging containers (materials) have been formulated and released (including the standards planned to be released in 2004), including 43 standards for packaging containers (materials) for medicinal glass bottles, accounting for 38% of the total number of standards for all pharmaceutical packaging villages. The scope of the standard covers pharmaceutical glass bottle packaging containers for various dosage forms such as injection powder, water injection, infusion, tablet, pill, oral liquid and freeze-dried, vaccine, and blood products. A relatively complete and standardized standardization system for medicinal glass bottles has been initially formed. The formulation, release and implementation of these standards, the replacement of pharmaceutical glass bottles and containers, the improvement of product quality, the assurance of drug quality, the acceleration of the integration with international standards and the international market, and the promotion and regulation of the healthy, orderly and rapid development of China's pharmaceutical glass industry , has a pivotal significance and role.
Pharmaceutical glass bottles are packaging materials that directly contact medicines, occupy a large proportion in the field of pharmaceutical packaging materials, and have irreplaceable performance and advantages. Its standards have a crucial impact on the quality of pharmaceutical packaging and the development of the industry.
