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

20160316 ECA新闻：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  

   

http://www.gmp-compliance.org/enews_05243_USP-proposes-revision-of-general-chapter--1225--Validation-of-compendial-procedures-Adding-a-section-on-Life-Cycle-Management.html

GMP News
16/03/2016

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 toincorporate a section on "Lifecycle Management of AnalyticalProcedures". The revision is an attempt to better align the validationconcept with the recently (July 2015) issued FDA guidance "Analytical Proceduresand Methods Validation for Drugs and Biologics", which also includes asection on "Life Cycle Management 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 cycleManagement" in general chapter <1225> states that "once acompendial procedure is successfully validated (or verified) and implemented,the procedure should be monitored during the routine use to continually assurethat the procedure remains fit for its intended purpose. Trend analysis onperformance should be carried out in order to provide documented evidence thatthe procedure performs to the required standard and to evaluate the need tooptimize and revalidate all or a part of the analytical procedure. If ananalytical procedure can only meet the established system suitabilityrequirements with repeated adjustments to the operating conditions stated inthe analytical procedure, the analytical procedure should be reevaluated,amended, and revalidated, as appropriate. Over the commercial life of aproduct, new information and risk assessments (e.g., awareness of a newimpurity) may necessitate the development and validation of a new or analternative analytical procedure. New technologies used for testing may allowfor greater understanding and/or confidence when testing (or assessing) productquality. Therefore, the appropriateness of analytical procedures should also beperiodically evaluated, and new or alternative validated procedures may be 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 "The Dissolution Procedure: Development and Validation"<1092> is being added 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 PF42(2) a stimuli article on "Fitness for Use: Decision Rules and TargetMeasurement Uncertainty" has been published. The present article addressesseveral of these topics in detail: what are decision rules, how are theydeveloped, and how is the target measurement uncertainty determined. TheValidation and Verification Expert Panel seeks reader comments on the contentsof this Stimuli article.

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 articleemphasizes, that

在其介绍中，文章强调：

"A major, if not the mostimportant, driver for adopting the lifecycle approach to an analyticalprocedure is to ensure that the reportable result is fit for use. It isimportant, therefore, to understand what the result will be used for and tohave a way of defining criteria that can be used to assess the fitness ofresults for their purpose or use. Reportable results are generated in order tomake decisions; however, the challenge is clearly defining the decision beingmade with the reportable result. Currently, there is no clear, commonly used,and internationally agreed upon process to follow that defines whether areportable result is fit for use. The development of decision rule (DR)concepts provides an approach that can be helpful for determining fit foruse."

“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) concisely defines the requirements for a reportable result to be fit foruse. The DR defines the use of the reportable result, and can provide theinformation, such as acceptable probabilities, needed to set the targetmeasurement uncertainty (TMU). The TMU can become part of the ATP, which isvaluable to the pharmaceutical industry because it provides a mathematicalproof that reportable 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 tolerancefor MU (bias and uncertainty) associated with the reportable result may bedifferent for each use. The uncertainty that is acceptable for the reportableresult to release a lot may be larger than that required for the stabilitystudy of that lot. Following a defined process using knowledge management, riskanalysis, and process mapping helps define the uses of the reportable resultand its required quality. Each use will require its own DR and ATP because themeasurand and acceptable 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。”

Following your registration on the USP Pharmacopeial Forum websiteyou can get to the proposal for general chapter <1225> and thecomplete stimuli article.

在USP药典论坛注册后，可以查看拟定的<1225>。

http://zhuyujiao1972.blog.163.co ... 727201621685559209/