16-18 November 2021
Following to the Stimuli Article "Lifecycle Management of Analytical Procedures: Method Development, Procedure Performance Qualification, and Procedure Performance Verification" published in Pharmacopeial Forum 39(5) (September-October 2013), the USP now proposed a revision of general chapter <1225> "Validation of compendial procedures" in PF 42(2) (March-April 2016).
This chapter is being revised to incorporate a section on "Lifecycle Management of Analytical Procedures". The revision is an attempt to better align the validation concept with the recently (July 2015) issued FDA guidance "Analytical Procedures and Methods Validation for Drugs and Biologics", which also includes a section on "Life Cycle Management of Analytical Procedures".
The added section on "Life cycle Management" in general chapter <1225> states that "once a compendial procedure is successfully validated (or verified) and implemented, the procedure should be monitored during the routine use to continually assure that the procedure remains fit for its intended purpose. Trend analysis on performance should be carried out in order to provide documented evidence that the procedure performs to the required standard and to evaluate the need to optimize and revalidate all or a part of the analytical procedure. If an analytical procedure can only meet the established system suitability requirements with repeated adjustments to the operating conditions stated in the analytical procedure, the analytical procedure should be reevaluated, amended, and revalidated, as appropriate. Over the commercial life of a product, new information and risk assessments (e.g., awareness of a new impurity) may necessitate the development and validation of a new or an alternative analytical procedure. New technologies used for testing may allow for greater understanding and/or confidence when testing (or assessing) product quality. Therefore, the appropriateness of analytical procedures should also be periodically evaluated, and new or alternative validated procedures may be considered."
Also, a reference to general chapter "The Dissolution Procedure: Development and Validation" <1092> is being added under "Data Elements Required for Validation".
Additionally in the same issue of PF 42(2) a stimuli article on "Fitness for Use: Decision Rules and Target Measurement Uncertainty" has been published. The present article addresses several of these topics in detail: what are decision rules, how are they developed, and how is the target measurement uncertainty determined. The Validation and Verification Expert Panel seeks reader comments on the contents of this Stimuli article.
In its introduction the article emphasizes, that
"A major, if not the most important, driver for adopting the lifecycle approach to an analytical procedure is to ensure that the reportable result is fit for use. It is important, therefore, to understand what the result will be used for and to have a way of defining criteria that can be used to assess the fitness of results for their purpose or use. Reportable results are generated in order to make decisions; however, the challenge is clearly defining the decision being made with the reportable result. Currently, there is no clear, commonly used, and internationally agreed upon 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 be helpful for determining fit for use."
"The analytical target profile (ATP) concisely defines the requirements for a reportable result to be fit for use. The DR defines the use of the reportable result, and can provide the information, such as acceptable probabilities, needed to set the target measurement uncertainty (TMU). The TMU can become part of the ATP, which is valuable to the pharmaceutical industry because it provides a mathematical proof that reportable results are suitable for use."
"The required quality or tolerance for MU (bias and uncertainty) associated with the reportable result may be different for each use. The uncertainty that is acceptable for the reportable result to release a lot may be larger than that required for the stability study of that lot. Following a defined process using knowledge management, risk analysis, and process mapping helps define the uses of the reportable result and its required quality. Each use will require its own DR and ATP because the measurand and acceptable risks may be different."
Following your registration on the USP Pharmacopeial Forum website you can get to the proposal for general chapter <1225> and the complete stimuli article.