给药器具相容性指导原则英文版
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出国留学英语>可口可乐广告音乐This guiding principle mainly describes the compatibility rearch between injection and glass packaging containers, and aims to guide drug R&D and production enterpris to systema- tically and normatively conduct compatibility rearch between drugs and glass packaging containers, lect pharmaceutical glass (hereinafter referred to as glass) packaging containers during drug R&D, and confirm the applicability of chemical injection packaging systems throughout the R&D process, Finally, glass packaging containers with good compatibility with drugs shall be lected and ud to avoid possible safety risks caud by pharmaceutical packaging containers.
The guiding principles are formulated under the current regulations and standard system and the current cognitive level, and follow the measures for the administration of packaging materials and containers in direct contact with drugs (Order No. 13 of the State Food and Drug Administration), It follows to the idea of the technical guidelines for compatibility rea
rch between chemical drug injections and plastic packaging materials (Trial) (gsyjz (2012) No. 267) issued by the former State Food and drug administration, draws lessons from relevant guiding principles and relevant monographs at home and abroad, and focus on the compatibility rearch content related to injections and glass packaging containers. With the continuous improvement of relevant laws and regulations and the improvement of technical requirements for drug rearch, this guiding principle will be continuously revid and improved.
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This guiding principle mainly describes the compatibility study between injections and glass packaging containers. The compatibility study between other dosage forms and glass packaging containers is not detailed in this guiding principle. In addition, glass packaging containers are often ud together with components such as rubber plugs. Drug R & D and production enterpris can refer to the basic ideas of relevant guiding principles to carry out the compatibility study between preparations and other components and materials of glass packaging containers (such as rubber plugs).
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This guiding principle is bad on the consideration of current cognition, and other methods can also be adopted if they are proved to be scientific and reasonable.
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