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本帖最后由 roadman 于 2019-4-16 05:26 编辑
10.04.2019
USP Published New Drafts for General Chapters on Plastic Materials
USP发布了塑料物料通则新草案
In the current issue of Pharmacopeial Forum (PF) 45(2) [March-April 2019] the following general USP chapters have been re-published for comment (the comment deadline is May 31, 2019):
在药典论坛（PF）最新一期45(2) [2019年3月-4月]中，以下USP通则已经重新发布以征求意见（评论的截止日期是2019年5月31日）：
• <661> Plastic Packaging Systems and Their Materials of Construction,
• <661>塑料包装系统及其构造材料，
• <661.1> Plastic Materials Of Construction,
• <661.1>塑料构造材料，
• <661.2> Plastic Packaging Systems for Pharmaceutical Use,
• <661.2>药用塑料包装系统，
• <1661> Evaluation of Plastic Packaging Systems and Their Materials of Construction With Respect to Their User Safety Impact,
• <1661>评估塑料包装系统及其构造材料对用户安全的影响，
• <665> Plastic Materials, Components, and Systems Used in the Manufacturing of Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products,
• <665>用于药品和生物药物和产品制造的塑料材料、组件和系统，
• <1665> Characterization of Plastic Materials, Components, and Systems Used in the Manufacturing of Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products.
• <1665>用于药品和生物药物和产品制造的塑料材料、组件和系统的表征。
Proposed revision of <661>, <661.1>, <661.2>, and <1661>
<661>、<661.1>、<661.2>和<1661>的建议修订
• As reported before, the 2017 draft for <661.1> introduced the requirement to test on extractable elements. The requirement for extractable elements testing is now proposed to be removed from chapter <661.1>. According to the new draft "it is being left up to the material user to evaluate the need for extractable elements testing and, if such testing is necessary, to establish and justify the means by which testing is accomplished". An example of an extractable elements testing strategy is provided in <1661>.
• 如之前的报道，2017草案<661.1>引入了对可萃取元素进行测试的要求。现在建议从<661.1>章中删除可萃取元件测试的要求。根据新草案，“评估可萃取元素测试的需要并（如果此类测试是必要的）建立和证明完成测试的方法被留给物料用户”。 <1661>中提供了一个可萃取元素测试策略的示例。
• In addition, the implementation date for <661.1> and <661.2>, is being changed from May 1, 2020 to December 1, 2025.
• 此外，<661.1>和<661.2>的实施日期正2020年5月1日改为2025年12月1日。
• The four chapters are also being revised to align with each other and to describe all of the plastic materials that are included in <661.1>, including the process of materials assessment, along with the applicability and application of <661.1>.
• 这4章也正在修订以相互一致，并描述<661.1>中包含的所有塑料材料，包括材料评估过程，以及<661.1>的适用性和应用。
• Furthermore, four new polymer descriptions [polyamide 6; polycarbonates; poly(ethylene-vinyl acetate); and polyvinyl chloride] have been added.
• 此外，四种新的聚合物的描述[聚酰胺6；聚碳酸酯；聚（乙烯-乙酸乙烯酯）和聚氯乙烯]已被添加。
Proposed revision of <665> and <1665>
<665>和<1665>的建议修订
A previous proposal for the new USP chapter <665> was published as Polymeric Components and Systems Used in the Manufacturing of Pharmaceutical and Biopharmaceutical Drug Products <665> in PF 43(3). On the basis of comments received, that proposal was cancelled and is replaced by the current proposal with the following significant changes:
先前关于USP新章节<665>的提案作为用于药品和生物药品制造的聚合物组件和系统<665>在PF 43(3)中公布。根据收到的意见，该提案被取消，并由当前提案取代，有以下重大变化：
• Include sufficient information in the chapter to allow for its execution.
• 在章节中包含足够的信息以便其执行。
• Clarify the scope with respect to components, drug substances, and drug products.
• 明确组件、药物和药品的范围。
• Delineate the hierarchical relationship between component and materials testing.
• 描述组件和材料测试之间的层次关系。
• Remove the concepts of compatibility and grandfathering exemption.
• 删除兼容性和祖父豁免的概念。
• Provide for flexibility regarding the design of the risk evaluation matrix.
• 为风险评估矩阵的设计提供灵活性。
• Generate a set of baseline chemical and biological tests for materials of construction.
• 为构造材料生成一套基准化学和生物测试。
• Revise the risk-based chemical and biological reactivity testing requirements for components.
• 修改基于风险的组件化学和生物反应性测试要求。
• Revise the extractable elements testing to align with other USP chapters.
• 修改可萃取元素测试以与其他USP章节保持一致。
In addition, there have been comments regarding the applicability of <665> and the mechanism by which this will occur within the USP–NF. According to USP, "the expert committee will work with stakeholders, via comments submitted to this proposal, an upcoming workshop, and other stakeholder engagement activities to determine how best to incorporate this chapter into the USP–NF". To facilitate the use and support the understanding of <665>, a new informational chapter <1665> has been proposed. The new chapter discusses material characterization, selection and qualifications of plastic components and systems used to manufacture active pharmaceutical ingredients, biopharmaceutical drug substances, and biopharmaceutical and pharmaceutical drug products.
此外，还有关于<665>的适用性以及在USP-NF中发生这种情况的机制的评论。根据USP，“专家委员会将与利益相关方合作，通过提交给该提案的意见、即将召开的研讨会、以及其他利益相关方参与活动，以确定如何最好地将本章纳入USP-NF”。为了便于使用和支持对<665>的理解，已经提出了新的信息章节<1665>。新章节讨论了用于制造活性药物成分、生物药物以及生物药品和药品的塑料组件和系统的材料表征、选择和确认。
Furthermore, it has been announced in Pharmeuropa that new Ph. Eur texts on plastic/ elastomeric materials will be elaborated:
此外，关于塑料/弹性体材料的新EP文本已经在欧洲药典网站上宣布，将详细阐述：
• 3.1.17 Cyclo-olefin copolymers (COC),
• 3.1.17环烯烃共聚物（COC），
• 3.1.18 Styrene block copolymers (SBC) for containers and closures for parenteral preparations and ophthalmic preparations.
• 3.1.18用于肠胃外制剂和眼科制剂的容器和密封件的苯乙烯嵌段共聚物（SBC）。
Following your online registration to Pharmacopeial Forum, you will have access to the full texts of the published USP packaging chapters.
在药典论坛在线注册后，您将可以访问已发布的USP包装章节的全文。
原文：http://www.gmp-compliance.org/gm ... n-plastic-materials
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发表于 2019-4-16 22:23:11
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