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USP proposes revision of general chapter<1225> Validation of compendial procedures: Adding a section on LifeCycle Management USP拟定通则<1225>药典方法验证修订：增加生命周期管理的部分 Following to the Stimuli Article"Lifecycle Management of Analytical Procedures: Method Development,Procedure Performance Qualification, and Procedure PerformanceVerification" published in Pharmacopeial Forum 39(5) (September-October2013), the USP now proposed a revision of general chapter<1225> "Validation of compendial procedures" in PF 42(2)(March-April 2016). 在药典论坛39（5）（2013年9-10月）中公布了“分析方法的生命周期管理：方法研发、方法性能验证，和方法性能确认”倡议文之后，USP现在在PF42（2）（2016年3-4月）拟定了对通则<1225>“药典方法的验证”的修订。 This chapter is being revised to incorporate a section on"Lifecycle Management of Analytical Procedures". The revision is anattempt to better align the validation concept with the recently (July 2015)issued FDA guidance "Analytical Procedures and Methods Validation forDrugs and Biologics", which also includes a section on "Life CycleManagement of Analytical Procedures". 本章的修订是为了在其中增加一个章节“分析方法生命周期的管理”。修订是努力将验证概念与最近（2015年7月）颁发的FDA指南“药品和生物制品分析方法和方法验证”保持一致，它也包括一个关于“分析方法生命周期管理”的部分。 The added section on "Life cycle Management" ingeneral chapter <1225> states that "once a compendial procedure issuccessfully validated (or verified) and implemented, the procedure should bemonitored during the routine use to continually assure that the procedureremains fit for its intended purpose. Trend analysis on performance should becarried out in order to provide documented evidence that the procedure performsto the required standard and to evaluate the need to optimize and revalidateall or a part of the analytical procedure. If an analytical procedure can onlymeet the established system suitability requirements with repeated adjustmentsto the operating conditions stated in the analytical procedure, the analyticalprocedure should be reevaluated, amended, and revalidated, as appropriate. Overthe commercial life of a product, new information and risk assessments (e.g.,awareness of a new impurity) may necessitate the development and validation ofa new or an alternative analytical procedure. New technologies used for testingmay allow for greater understanding and/or confidence when testing (or assessing)product quality. Therefore, the appropriateness of analytical procedures shouldalso be periodically evaluated, and new or alternative validated procedures maybe considered." 增加的“生命周期管理”部分中说，“一旦一个药典方法验证（或确认）成功并实施，则分析方法在日常使用中应进行监测，以持续确保方法保持其适用其既定目标。对性能要进行趋势分析，以提供书面证据证明分析方法的执行符合所需的标准，以及评估优化和再验证分析方法的全部或一部分的需求。如果一个分析方法仅仅只是符合既定的系统适用性要求，对分析方法里要求的运行条件进行重复的调整，分析方法应进行再评估、增补，适当时进行再验证。在一个药品的商业生命期内，新的信息和风险评估（例如，对新杂质的了解）可能使得开发和验证一个新的或一个替代的分析方法成为必要。在测试（或评估）产品质量时，用于测试的新技术可能会有更多的了解和/或置信度。因此，分析方法的适当程度也应定期进行评估，要考虑新的或可替代的经过验证的方法。” Also, a reference to general chapter "TheDissolution Procedure: Development and Validation" <1092> is beingadded under "Data Elements Required for Validation". 还有，在“验证所需的数据要素”中也增加了对<1092>“溶出度方法：研发和验证”的引用。 Additionally in the same issue of PF 42(2) a stimuliarticle on "Fitness for Use: Decision Rules and Target MeasurementUncertainty" has been published. The present article addresses several ofthese topics in detail: what are decision rules, how are they developed, andhow is the target measurement uncertainty determined. The Validation andVerification Expert Panel seeks reader comments on the contents of this Stimuliarticle. 另外，在相同PF42（2）里，也发布了一份“使用适当性：决策规则和目标测量不确定度”倡议文。该文章详细说了几个这样的主题：什么是决策规则、如何建立它们、如何确定目标测量不确定度。验证和确认专家组寻求读者对此倡议文件提出建议。 In its introduction the article emphasizes, that 在其介绍中，文章强调： "A major, if not the most important, driver foradopting the lifecycle approach to an analytical procedure is to ensure thatthe reportable result is fit for use. It is important, therefore, to understandwhat the result will be used for and to have a way of defining criteria thatcan be used to assess the fitness of results for their purpose or use.Reportable results are generated in order to make decisions; however, thechallenge is clearly defining the decision being made with the reportableresult. Currently, there is no clear, commonly used, and internationally agreedupon process to follow that defines whether a reportable result is fit for use.The development of decision rule (DR) concepts provides an approach that can behelpful for determining fit for use." “一个重要的，如果不是最重要的话， 促使在分析方法中采纳生命周期方法的原因是确保可报告的结果适合于其用途。因此，很重要的一点是要了解结果的用途是什么，有一个方法定义可以用于评估结果是否符合其目标或用途的适合性的标准。产生可报告的结果是为了做出决策，但是，挑战中清楚地定义了根据可报告结果做出的决策。现在，有一点不清楚，但常规使用着，并且有意识地同意流程，遵守一个可报告结果是否适合于其用途的定义。决策规则（ＤＲ）概念提供了一个方法，可以有助于决定适合于其用途。” "The analytical target profile (ATP) conciselydefines the requirements for a reportable result to be fit for use. The DRdefines the use of the reportable result, and can provide the information, suchas acceptable probabilities, needed to set the target measurement uncertainty(TMU). The TMU can become part of the ATP, which is valuable to thepharmaceutical industry because it provides a mathematical proof thatreportable results are suitable for use." “分析目标概况（ATP）简洁地定义了一个可报告结果符合其用途的要求。DR定义了可报告结果的用途，可以提供所需信息，例如可接受概率，来设定目标测量不确定度（TMU）。TMU可以成为ATP的一部分，它对于制药行业很有价值，因为它提供了一种数学证据来证明可报告结果是适合其用途的。” "The required quality or tolerance for MU (bias anduncertainty) associated with the reportable result may be different for eachuse. The uncertainty that is acceptable for the reportable result to release alot may be larger than that required for the stability study of that lot.Following a defined process using knowledge management, risk analysis, andprocess mapping helps define the uses of the reportable result and its requiredquality. Each use will require its own DR and ATP because the measurand andacceptable risks may be different." “可报告结果的MU（偏见和不确定度）所需的质量或允差可能会因各自用途而不同。放行一个批次的可报告结果可以接受的不确定度可能会比该批次所用的稳定性研究方法所需的不确定度大些。使用知识管理、风险分析和过程分布定义一个流程，有助于定义可报告结果的使用，及其所需质量。每个用途都要有其自己的DR和ATP，因为被测量和可接受风险可能会不同。” 在USP药典论坛注册后，可以查看拟定的<1225>。
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