Standards and standardization systems for glass bottles

Article 52 of the "Drug Administration Law of the People's Republic of China" stipulates: "Packaging materials and containers in direct contact with drugs must meet the requirements and safety standards for medicinal use." Article 44 of the "Regulations for the Implementation of the Drug Administration Law of the People's Republic of China" stipulates: "Direct contact The management measures, product catalogs, and medicinal requirements and standards for drug packaging materials and containers are formulated and announced by the drug regulatory department of the State Council." In accordance with the above-mentioned laws and regulations, the State Drug Administration has been organized in phases and batches since 2002 113 standards for pharmaceutical packaging containers (materials) have been formulated and released (including the planned release standards in 2004), of which 43 are standards for packaging containers (materials) for medicinal glass bottles. 

The number of standards accounts for 38% of the total number of standards for all pharmaceutical packaging villages. The scope of the standard covers medicinal glass bottle packaging containers for various dosage forms such as powder injections, water injections, infusions, tablets, pills, oral liquids, freeze-dried, vaccines, and blood products. A relatively complete and standardized standardization system for medicinal glass bottles has been preliminarily formed. The formulation, release and implementation of these standards will update the packaging and containers of pharmaceutical glass bottles, improve product quality, ensure drug quality, accelerate the integration with international standards and the international market, and promote and regulate the healthy, orderly and rapid development of China's pharmaceutical glass industry , Has a pivotal meaning and role.

Pharmaceutical glass bottles are packaging materials that directly contact drugs, occupy a large proportion in the field of pharmaceutical packaging materials, and have irreplaceable performance and advantages. Their standards have a vital impact on the quality of pharmaceutical packaging and the development of the industry.