Management measures for the latest drug packaging
2022-09-28- Detail
Management measures for new drug packaging materials: simplify procedures and improve standards
the State Food and Drug Administration revised the management measures for drug packaging materials yesterday. The new method simplifies the registration and approval procedures and improves the safety standards of drug packaging materials
the new standard is formulated by the state. Its biological material is aimed at the packaging bag material and 3D printing technology with plastic, kraft paper and whiteboard as the packaging substrate, which has broad prospects and will replace the past three-level standards of the country, industry and enterprise. In 6.3 of the products, Party A's factory environment: power fluctuation range: 380V 10%; Frequency 50Hz 3%; Ambient temperature requirements: 1030 ℃; Humidity: less than 90%, higher requirements are made in terms of material, shape and stability
the new standard is verified and rechecked by the designated testing institution, and finally approved by the National Pharmacopoeia Committee
in terms of registration approval, the original national and local level approval has been changed to national level approval, and the designated inspection agency will inspect the drug package materials applied for registration according to the new standards. Those who are unqualified shall not be registered
the drug administration department will also regularly inspect the influence of packaging materials on drug quality. 1. The measuring principle of electrode tension testing machine, formulate a catalogue of qualified products, and publish unqualified products. It is understood that at present, China's pharmaceutical packaging materials still have some problems, such as inconvenient access, unstable ingredients and lack of children's packaging
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