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20151104 ECA新闻:关于可萃出物和浸出物的新USP通则<1663>、<1664> GMP News
04/11/2015 New USP General Chapters on Extractablesand Leachables: <1663>, <1664> 关于可萃出物和浸出物的新USP通则<1663>、<1664> Two new USP General Chapters onextractables and leachables which had been proposed in Pharmacopeial Form39 (5) have become official on August 1, 2015 (USP 38-NF33, first supplement): 在药典论坛39(5)中拟定两个关于可萃出物和浸出物的新通则自2015年8月1日正式公布(USP38-NF33,第一增补): · <1663> Assessment of Extractables Associatedwith Pharmaceutical Packaging/Delivery Systems and · <1663>药用包装/给药系统中的可萃出物评估 · <1664> Assessment of Drug Product LeachablesAssociated with Pharmaceutical Packaging/Delivery systems. · <1664>药用包装/给药系统中药品可浸出物评估 These chapters are intended to beinformational. They provide a framework for the design, justification, andexecution of extractables/leachables assessments for pharmaceutical packagingsystems. They do not present specific experimental conditions, specific tests,analytical procedures or acceptance limits for packaging systems or products. 这两章目的是提供相关信息。他们提供了设计、论证和实施药品包装系统中可萃出物/浸出物评估的框架。他们并没有给出包装系统或药品的详细实验条件、特定测试、分析方法或可接受限度。 Additionally, the PSD Expert Committeeplans a general chapter <1665> on the Toxicological SafetyAssessment of Extractables and Leachables (announced in PF and39(6)). The chapter is expected to provide a framework for performinga toxicological safety assessment. It is not expected to providespecific protocols or specifications. 另外,PSD专家组正在策划一个通则<1665>,是关于可萃出物和浸出物的毒性安全评估(在PF39(6)中公布)。该章节将提供实施毒性安全评估的框架,但并不提供详细的实施方案或质量标准。 However, the above mentioned GeneralChapters might get a more official character when implemented in USPMonographs or General Chapters on dosage forms products-quality tests. In therecent issue of PF 41(5) reference to the two new Chapters <1663> and <1664> has been integrated in the Drafts of General Chapters onOphthalmic Products <771> and Injections <1>. Therefore, infuture, it might be necessary to discuss the scientific principles andbest demonstrated practices for extractables/leachables studies. In addition,the assessment of possible leachables/extractables and the establishment ofacceptance criteria for these substances might be based on riskassessments for a specific combination of product, indication, route ofadministration, and packaging system. The comment deadline for the in PF41(5) proposed chapters is November 30, 2015. 在实施与制剂剂型相关的质量测试的USP各论或通论时,上述通则可能会有更多正式章节。在最近PF41(5)中,这两个新章节<1663>和<1664>已经被整合进了眼剂<771>和注射剂<1>的通则草案中。国在线,在将来,可能会需要讨论可萃出物/浸出物研究的科学原理和经过证明的规范,并根据特定的产品、指票、给药途径和包装系统组合的风险评估来为这些物质建立可接受标准。在PF41(5)中所拟章节的征求意见截止时间为2015年11月30日。 免费注册后,你可以登录USP药典论坛获得完整的USP通则草案。
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