分析方法的生命周期：USP<1210>“统计工具”，分析目标概况和分析控制策略

GMP News
14/09/2016

Analytical Lifecycle: USP <1210> "Statistical Tools", Analytical Target Profile and Analytical Control Strategy

分析方法的生命周期：USP<1210>“统计工具”，分析目标概况和分析控制策略

Following the recently announced elaboration of a new general chapter <1220> "The Analytical Procedure Lifecycle" the United States pharmacopeia (USP) is now proceeding in its approach for a comprehensive analytical lifecycle concept. A further step towards this approach is the draft of a new USP General Chapter <1210> Statistical Tools for Procedure Validation which has been published in Pharmacopeial Forum (PF) 42(5) in September 2016. Comment deadline is November 30, 2016.

在最近宣布起草新的通则<1220>“分析方法生命周期”之后，USP现在正在建议全面的分析方法生命周期概念。此方法的下一步是起草新的USP通则<1210>“分析方法验证的统计工具”，它在2016年9月公布在药典论坛PF42（5），征求意见的截止日期为2016年11月30日。

Additionally, two Stimuli Articles regarding "Analytical Control Strategy" and "Analytical Target Profile: Structure and Application Throughout The Analytical Lifecycle" appeared in the same issue of the PF.

另外，在同一期PF上还出现了2篇关于“分析方法控制策略”和“分析方法目标概况：分析方法整个生命周期中结构和应用”的启动文。

In the draft chapter <1210> Statistical Tools for Procedure Validation, the USP Statistics Expert Committee presents a revision to the proposal of <1210> published in PF 40(5) [Sept.–Oct. 2014]. On the basis of the comments and feedback given by stakeholders, the committee has addressed their concerns about the narrow scope and details on methodology to be used. The chapter is proposed as a companion to general chapter <1225> Validation of Compendial Procedures with the purpose of providing statistical methods that can be used in the validation of analytical procedures. A revision of general chapter <1225>, including a new section on Lifecycle Management of Analytical Procedures, has been published for comment in PF 42(2) in March 2016.

在草案<1210>“分析方法验证统计学工具”中，USP统计学专家委员会对PF40（5）【2014年9-10月】中公布的<1210>提议进行了修订。在利益相关方所给出的建议和反馈基础上，委员会说明了其对小范围和要使用的方法学细节的担忧。该章节是作为通则<1225>“药典方法的验证”相伴的章节提出来的，其目的是提供统计学方法，用于分析方法的验证。修订后的通则<1225>包括关于“分析方法生命周期管理”的新部分，在2016年3月PF42（2）中公布。

Specifically, the revision clarifies the accuracy and precision calculations while removing specific linearity requirements. Linearity may be inferred from accuracy or other statistical methods as deemed appropriate. The chapter discusses all of the following analytical performance characteristics from a statistical perspective:

具体来说，修订说明了在清除特定的线性要求时的准确度和精密度计算。线性可以引用准确度数据，其它统计学方法也是适当的。该章节从统计学角度讨论了以下所有分析方法性能特性：

• accuracy, 准确度
• precision, 精密度
• range, 范围
• detection limit, 检出限
• quantitation limit, 定量限
• and linearity. 线性
  

Additional related topics that are discussed in the draft include statistical power, two one-sided tests of statistical equivalence, tolerance intervals, and prediction intervals.

在草案中还讨论了相关的其它主题，包括统计功效、统计等效性双单侧检验、允差区间和预测区间。

Furthermore, up to now, four Stimuli Articles regarding the analytical lifecycle have been published:

另外，到目前为止，已发布了分析方法生命周期方面的4份启动文：

• "Lifecycle Management of Analytical Procedures: Method Development, Procedure Performance Qualification, and Procedure Performance Verification" in PF 39(5),
• “分析方法生命周期管理：方法建立、分析方法性能验证和方法性能确认”，PF39(5)
• "Fitness for Use: Decision Rules and Target Measurement Uncertainty" in PF 42(2),
• “使用适当性：决策规则和目标测量不确定度”，PF42（2）
  

and new in PF 42(5) 以及在PF42（5）中新的

• "Analytical Control Strategy", and
• “分析方法控制策略”和
• "Analytical Target Profile: Structure and Application Throughout The Analytical Lifecycle".
• “分析目标概况：分析方法生命周期中的结构和申报”
  

The Analytical Target Profile (ATP) is the focal point of the lifecycle approach. It is comparable to the Quality Target Product Profile (QTPP) which is defined in ICH Q8. The Stimuli Article emphasizes "that the current approach to development, validation, verification, and transfer of analytical procedures has served the industry well." The lifecycle approach - comprised of the development (design, stage 1), qualification (stage 2), and monitoring of the performance of analytical procedures (control strategy, stage 3) - is an extension of the current guidance, taking advantage of the learnings from ICH Q8 - quality by design (QbD) concepts. The Article considers in particular the following questions (and provides examples):

分析方法目标概况（ATP）是生命周期方法的焦点。它与ICH 18中定义的质量目标产品概况（QTPP）是具有可比性的。启动文强调说“目前分析方法研发、验证、确认和转移的方法为行业做了很好的服务”。生命周期方法---包括研发（设计，第1阶段）、验证（第2阶段）和分析方法性能监控（控制策略、第3阶段）----是当前指南的延伸，是学自ICH Q8---质量源于设计（QBD）概念的。文章尤其考虑了以下问题（并提供了例子）：

• What is an ATP, and why is it useful?
• ATP是什么，为什么有用？
• How can the ATP criteria be established?
• 如何建立ATP标准？
• How can an ATP be applied during the three stages of the procedure lifecycle?
• 在分析方法生命周期的三个阶段如何应用ATP？
  

According to the article, "an additional advantage of using an ATP is that it can drive the development of a robust control strategy, resulting in better, more consistent performance of an analytical procedure throughout its lifecycle."

根据文章，“使用ATP的额外优点是它可以促进稳健控制策略的研发，获得在其生命周期中更好更一致的分析方法性能”。

In the Stimuli Article on the Analytical Control Strategy (ACS), the following questions are discussed:

在分析方法控制策略（ACS）的启动文中，讨论了以下问题：

• What is the ACS?
• 什么是ACS？
• What is the relationship between the ACS and the ATP?
• ACS和ATP之间有什么关系？
• What is the quality risk management (QRM) process and how can it be applied to an analytical procedure?
• 什么是质量风险管理（QRM）过程，如何应用于分析方法？
• How does the ACS apply to the product lifecycle?
• ACS如何应用于产品生命周期？
  

Additionally, examples of the following are provided:

还有，提供了以下例子：

• How to develop an ACS using the QRM process, and
• 如何使用QRM流程来研发ACS，以及
• How to develop and apply a risk-based replicate strategy to minimize variability.
• 如何研发并应用基于风险的重复策略来减少波动
  

The USP Expert Panel would appreciate any feedback on the suggested approaches, as well as any alternative approaches for consideration.

USP专家工作组会感谢对所建议方法的所有反馈，以及所提供的替代性方法。

Following your registration on the USP Pharmacopeial Forum website you can get to the proposal for general chapter <1210> and the complete stimuli articles. Because of the importance of the new USP chapter <1220>, ECA and USP join forces and organise the first joint event "Lifecycle Approach of Analytical Procedures", in Prague, Czech Republic, from 8 to 9 November 2016.

在药典论坛注册后，即可以下载草案。

来源：Julia