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則<1220>“分析方法生命周期”之后，USP現(xiàn)在正在建議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通則<1210>“分析方法驗(yàn)證的統(tǒng)計(jì)工具”，它在2016年9月公布在藥典論壇PF42（5），征求意見的截止日期為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上還出現(xiàn)了2篇關(guān)于“分析方法控制策略”和“分析方法目標(biāo)概況：分析方法整個(gè)生命周期中結(jié)構(gòu)和應(yīng)用”的啟動(dòng)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>“分析方法驗(yàn)證統(tǒng)計(jì)學(xué)工具”中，USP統(tǒng)計(jì)學(xué)專家委員會(huì)對(duì)PF40（5）【2014年9-10月】中公布的<1210>提議進(jìn)行了修訂。在利益相關(guān)方所給出的建議和反饋基礎(chǔ)上，委員會(huì)說明了其對(duì)小范圍和要使用的方法學(xué)細(xì)節(jié)的擔(dān)憂。該章節(jié)是作為通則<1225>“藥典方法的驗(yàn)證”相伴的章節(jié)提出來的，其目的是提供統(tǒng)計(jì)學(xué)方法，用于分析方法的驗(yàn)證。修訂后的通則<1225>包括關(guān)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:具體來說，修訂說明了在清除特定的線性要求時(shí)的準(zhǔn)確度和精密度計(jì)算。線性可以引用準(zhǔn)確度數(shù)據(jù)，其它統(tǒng)計(jì)學(xué)方法也是適當(dāng)?shù)?。該章?jié)從統(tǒng)計(jì)學(xué)角度討論了以下所有分析方法性能特性：
and linearity. 線性
Additional related topics that are discussed in the draft include statistical power, two one-sided tests of statistical equivalence, tolerance intervals, and prediction intervals.在草案中還討論了相關(guān)的其它主題，包括統(tǒng)計(jì)功效、統(tǒng)計(jì)等效性雙單側(cè)檢驗(yàn)、允差區(qū)間和預(yù)測區(qū)間。
Furthermore, up to now, four Stimuli Articles regarding the analytical lifecycle have been published:另外，到目前為止，已發(fā)布了分析方法生命周期方面的4份啟動(dòng)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、分析方法性能驗(yàn)證和方法性能確認(rèn)”，PF39(5)
'Fitness for Use: Decision Rules and Target Measurement Uncertainty' in PF 42(2),“使用適當(dāng)性：決策規(guī)則和目標(biāo)測量不確定度”，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 Pro file: Structure and Application Throughout The Analytical Lifecycle'.“分析目標(biāo)概況：分析方法生命周期中的結(jié)構(gòu)和申報(bào)”
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):分析方法目標(biāo)概況（ATP）是生命周期方法的焦點(diǎn)。它與ICH 18中定義的質(zhì)量目標(biāo)產(chǎn)品概況（QTPP）是具有可比性的。啟動(dòng)文強(qiáng)調(diào)說“目前分析方法研發(fā)、驗(yàn)證、確認(rèn)和轉(zhuǎn)移的方法為行業(yè)做了很好的服務(wù)”。生命周期方法---包括研發(fā)（設(shè)計(jì)，第1階段）、驗(yàn)證（第2階段）和分析方法性能監(jiān)控（控制策略、第3階段）----是當(dāng)前指南的延伸，是學(xué)自ICH Q8---質(zhì)量源于設(shè)計(jì)（QBD）概念的。文章尤其考慮了以下問題（并提供了例子）：
What is an ATP, and why is it useful?ATP是什么，為什么有用？
How can the ATP criteria be established?如何建立ATP標(biāo)準(zhǔn)？
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個(gè)階段如何應(yīng)用ATP？
According to the article, 'an additional advantage of using an ATP is that it can drive the development of a robustcontrol strategy, resulting in better, more consistent performance of an analytical procedure throughout its lifecycle.'
根據(jù)文章，“使用ATP的額外優(yōu)點(diǎn)是它可以促進(jìn)穩(wěn)健控制策略的研發(fā)，獲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）的啟動(dòng)文中，討論了以下問題：
什么是ACS？
What is the relationship between the ACS and the ATP?ACS和ATP之間有什么關(guān)系？
What is the quality risk management (QRM) process and how can it be applied to an analytical procedure?什么是質(zhì)量風(fēng)險(xiǎn)管理（QRM）過程，如何應(yīng)用于分析方法？
How does the ACS apply to the product lifecycle?ACS如何應(yīng)用于產(chǎn)品生命周期？
Additionally, examples of the following are provided:還有，提供了以下例子：
How to develop an ACS using the QRM process, and如何使用QRM流程來研發(fā)ACS，以及
How to develop and apply a risk-based replicate strategy to minimize variability.如何研發(fā)并應(yīng)用基于風(fēng)險(xiǎn)的重復(fù)策略來減少波動(dòng)
The USP Expert Panel would appreciate any feedback on the suggested approaches, as well as any alternative approaches for consideration.
USP專家工作組會(huì)感謝對(duì)所建議方法的所有反饋，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.
