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Drafts of revised USP plastic packagingchapters <661.1> and <661.2>: removal of the biological reactivitytest for oral and topical dosage forms 修订USP塑料包装<661.1>和<661.2>草案：删除口服和局部剂型中生物活性测试 In Pharmacopeial Forum 42(4) [Jun-Jul 2016] drafts oftwo revised USP general chapters <661.1> Plastic Materials ofConstruction and <661.2> Plastic Packaging Systems forPharmaceutical Use have been published for comment. Deadline for commentsis September 30, 2016. With these drafts, the USP General Chapters - Packagingand Distribution Expert Committee is removing the requirement for <87> BiologicalReactivity Tests, In Vitro testing for packaging materials and systems fororal and topical dosage forms. 在药典论坛42（4）【2016年6-7月】中，2份修订后的USP通论<661.1>“塑料材料”和<661.2>“药用塑料包装系统”已经公布征求意见。征求意见截止日期为2016年9月30日。有了这些草案，USP通论“包装和销售”专家委员会从<87>“生物活性测试”、体外测试对口服和局部给药剂型包材和包装系统要求中删除。 The Expert Committee is removing the requirement for<87> testing at this time, while the effort to revise the generalchapters <87> and Biological Reactivity Tests, In Vivo <88>proceeds. Depending on the revisions of <87> and <88> the twopackaging chapters may be revised to align with those chapters. 专家工作组此次会将<87>的要求删除，而修订通论<87>和“生物活性测试、体外”<88>则将继续。根据<87>和<88>的修订，两个包装章节可能会进行修订来与这些章节保持一致。 The new requirement (since May 2016) for<87> Biological Reactivity Tests, In Vitro testing for packagingmaterials and systems for oral and topical dosage forms has been highlydiscussed, since this testing is not required for the mentioned dosage formsaccording to EMA guideline on plastic immediate packaging materials (December2005) and US FDA container closure guidance (May 1999). In case of oral andtopical dosage forms both guidances require "only" compliance to foodregulations (EU: regulation 10/2011, US: indirect food additives guidelines)or, if applicable, (preferably) to pharmacopoeial monographs (if the materialor system is described in a pharmacopoeial chapter). <87> “生物活性测试，体外” 在口服和局部给药剂型的包材和包装系统使用进行了集中讨论，因为根据EMA塑料介质包装材料（2005年12月）指南，和美国FDA包装容器指南（1999年5月），此测试对于所提到的剂型并不需要。如果说口服和局部给药剂型两份指南都要求“仅”符合食品法规要求（EU指令10/2011，美国：非直接食品添加剂指南），或者，如果适用的话，（最好）符合药典各论（如果物料或系统在药典章节里有所描述）。 The principle of these two guidances is thatmaterials considered safe for food contact are also safe for topical and oraldosage form packaging systems. 这两份指南的原则是如果物料被认为食品接触是安全的，则用作口服和局部给药剂型包装系统也是安全的。 The new requirement (Biological Reactivity Tests,In Vitro) could have led to delays in releasing new oral or topicalproducts on the market. Additionally, one might have had to re-evaluate alreadyexisting oral and topical products packaging systems on the market. Therefore,the present decision to revise the two packaging chapters regarding therequirement for <87> Biological Reactivity Tests, In Vitro seemsto be justified. 新的要求（生物活性测试，体外）可能会导致新的口服或局部给药上市延迟。另外，大家可能必须重新评估现有销售药品的口服和局部给药包装系统。这样的话，修订两份关于<87>生物活性测试，体外的两个包装章节的决定看来需要进行论证。 Furthermore, the Expert Committee isproposing the addition of four new polymers [polyamide 6, polycarbonate,poly(ethylene-vinyl acetate), and polyvinyl chloride, plasticized] with testmethods and specifications to general chapter <661.1>. To supportthe addition of these new polymers, polymer descriptions have been added toEvaluation of Plastic Packaging Systems and Their Materials of Constructionwith Respect to Their User Safety Impact <1661>, which appeared in PF42(3) [May–June 2016]. 还有，专家委员会提议增加4种新的聚合物【聚酰胺6、聚碳酸、聚乙酸乙烯酯，以及塑化聚氯乙烯】和检验方法及质量标准至通论<661.1>中。为了支持增加这些新的聚合物，聚合物的描述已经被加到塑料包装系统及其构成材料的评估中，评估其用户安全影响<1661>，出现在PF42(3)【2016年5-6月】中。 In addition, the test for Spectral Transmission inContainers—Performance Testing <671> is being moved into general chapter<661.2> as requirement for light resistant containers. 此外，作为遮光容器要求的光谱透射测试---<67>性能测试被从通论<661.2>中删除。 On the basis of comments received, the scope of bothchapters was revised for clarification. 在收到的意见基础上，两章节的内容将会进行修订进行澄清。 在官网登记后即可获得完整版本
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