Standards u sistemi ta' standardizzazzjoni għall-fliexken tal-ħġieġ

Jan 14, 2021

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 percent 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.


Fliexken tal-ħġieġ farmaċewtiku huma materjali tal-ippakkjar li jikkuntattjaw direttament id-drogi, jokkupaw proporzjon kbir fil-qasam tal-materjali tal-ippakkjar farmaċewtiċi, u għandhom prestazzjoni u vantaġġi insostitwibbli. L-istandards tagħhom għandhom impatt vitali fuq il-kwalità tal-ippakkjar farmaċewtiku u l-iżvilupp tal-industrija.

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