文档介绍:659包装和储存条件<659>PACKAGINGANDSTORAGEREQUIREMENTS<659>包装和储存要求(eofficialMay1,2016)(本章节2016年5月1号正式生效)Deletethefollowing:以下内容删除:packagingportionofthestatement,,(APIs),thechoicewouldbetight,well-closedor,whereneeded,alight-,giventheirtypicalpresentationaslarge-modityitems(containersrangingfromdrumstotankcars),awell-。对于药品包装的要求,定义进行导向筛选和改编。对于API,要选择密封的、密闭性好的或者根据需要选择耐光的容器。对于赋形剂,和大容量商品一样,鉴于他们的典型性质,(容器从圆桶到罐车),默认是一个密闭性好的容器。Wherenospecificdirectionsorlimitationsareprovidedinthearticle’slabeling,articlesshallbeprotectedfrommoisture,freezing,andexcessiveheatand,wherenecessary,fromlightduring在物品的标签上没有提供特定的方向或局限性。物品在运输和配送过程中应该防潮、防冻、PACKAGING包装Packagingmustnotinteractphysicallyorchemicallywithofficialarticlesinanywaythatcausestheirsafety,identity,strength,quality,,从而导致他们的安全性、特性、强度、质量或纯度不符合要求。pharmaceuticalingredients(APIs),thecontainerchoicesaretight,well-closed,or,whereneeded,light-,giventheirtypicalpresentationaslarge-modityitems(containersrangingfromdrumstotankcars),awell-,wherenospecificdirectionsorlimitationsareprovided,articlesshallbeprotectedfrommoisture,freezing,andexcessiveheat,and,wherenecessary,。对于赋形剂,和大容量商品一样,鉴于他们的典型性质,(容器从圆桶到罐车),默认是一个密闭好的容器。没有提供特定的方向或局限性时,对于除了药物和药品外的其他物品,在运输和配送过程中应该防潮、防冻、防过热,必要时要避光。pendialrequirementsfortheuseofspecifiedcontainersapplyalsotoarticlesaspackagedbythepharmacistorotherdispenser,unlessotherwiseindicatedintheindividual使用指定容器的药典要求对药剂师或其他分配者包装物品时同样适用,除非在专论中另有GENERALDEFINITIONS一般概念Packagingsystem(alsoreferredtoasacontainer–closuresystem):ponentsthattogethercontainandprotecttheartic