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

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.

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.

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.

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:

  • accuracy,
  • precision,
  • range,
  • detection limit,
  • quantitation limit,
  • and linearity.

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

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

and new in PF 42(5)

  • "Analytical Control Strategy", and
  • "Analytical Target Profile: Structure and Application Throughout The Analytical Lifecycle".

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):

  • What is an ATP, and why is it useful?
  • How can the ATP criteria be established?
  • How can an ATP be applied during the three stages of the procedure lifecycle?

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."

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

  • What is the ACS?
  • What is the relationship between the ACS and the ATP?
  • What is the quality risk management (QRM) process and how can it be applied to an analytical procedure?
  • How does the ACS apply to the product lifecycle?

Additionally, examples of the following are provided:

  • How to develop an ACS using the QRM process, and
  • How to develop and apply a risk-based replicate strategy to minimize variability.

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

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