Article 52 of the "Drug Administration Law of the People's Republic of China" stipulates: "Packaging materials and containers that come into direct contact with pharmaceutical products must meet pharmaceutical requirements and safety standards." Article 44 of the "Regulations for the Implementation of the Drug Administration Law of the People's Republic of China" stipulates that "direct contact Drug packaging materials and containers management approach, product catalog and medical requirements and standards formulated and published by the State Council Drug Administration. "According to the above laws and regulations, the State Drug Administration since 2002, organized by stages Formulated and promulgated 113 standards for pharmaceutical packaging containers (including the planned release in 2004), of which 43 were standard pharmaceutical packaging containers (materials), accounting for 38% of the total standard of all pharmaceutical packaging villages, The standard range covers medical glass containers for injectable injection, water injection, infusion solutions, tablets, pills, oral solutions and lyophilized vaccines, blood products and other dosage forms. Has initially formed a relatively complete, standardized medical glass bottle standardization system. The promulgation and implementation of these standards, the replacement of the pharmaceutical glass bottles containers, improve product quality, ensure the quality of medicines, speed up with the international standards and international markets, promote and standardize China's pharmaceutical glass industry healthy, orderly and rapid development , Has a pivotal significance and role.
Medicinal glass bottles are direct contact with pharmaceutical packaging materials in the field of pharmaceutical packaging materials account for a large proportion, and has irreplaceable performance and advantages, the standard of the pharmaceutical packaging quality and industry development has a crucial impact.
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