Borman Phil J, Guiraldelli Amanda M, Weitzel Jane, Thompson Sarah, Ermer Joachim, Roussel Jean-Marc, Marach Jaime, Sproule Stephanie, Pappa Horacio N
US Pharmacopeia 12601 Twinbrook Pkwy, Rockville, Maryland 20851, United States.
AstraZeneca, Silk Road Business Park, Macclesfield, Cheshire SK10 2NA, United Kingdom.
Anal Chem. 2024 Jan 23;96(3):966-979. doi: 10.1021/acs.analchem.3c03708. Epub 2024 Jan 8.
The analytical procedure life cycle (APLC) provides a holistic framework to ensure analytical procedure fitness for purpose. USP's general chapter <1220> considers the validation activities that take place across the entire analytical procedure lifecycle and provides a three-stage framework for its implementation. Performing ongoing analytical procedure performance verification (OPPV) (stage 3) ensures that the procedure remains in a state of control across its lifecycle of use post validation (qualification) and involves an ongoing program to collect and analyze data that relate to the performance of the procedure. Knowledge generated during stages 1 (procedure design) and 2 (procedure performance qualification) is used as the basis for the design of the routine monitoring plan to support performance verification (stage 3). The extent of the routine monitoring required should be defined based on risk assessment, considering the complexity of the procedure, its intended purpose, and knowledge about process/procedure variability. The analytical target profile (ATP) can be used to provide or guide the establishment of acceptance criteria used to verify the procedure performance during routine use (e.g., through a system/sample suitability test (SST) or verification criteria applicable to procedure changes or transfers). An ATP however is not essentially required to perform OPPV, and a procedure performance monitoring program can be implemented even if the full APLC framework has not been applied. In these situations, verification criteria can be derived from existing validation or system suitability criteria. Elements of the life cycle approach can also be applied retrospectively if deemed useful.
分析程序生命周期（APLC）提供了一个整体框架，以确保分析程序符合预期目的。美国药典通则<1220>考虑了在整个分析程序生命周期中进行的验证活动，并为其实施提供了一个三阶段框架。进行持续的分析程序性能验证（OPPV）（第3阶段）可确保该程序在验证（确认）后的整个使用生命周期内保持受控状态，并且涉及一个持续的计划，以收集和分析与该程序性能相关的数据。在第1阶段（程序设计）和第2阶段（程序性能确认）期间生成的知识用作设计常规监测计划的基础，以支持性能验证（第3阶段）。所需常规监测的范围应根据风险评估来确定，同时考虑程序的复杂性、其预期目的以及有关过程/程序变异性的知识。分析目标轮廓（ATP）可用于提供或指导建立验收标准，以在常规使用期间验证程序性能（例如，通过系统/样品适用性测试（SST）或适用于程序变更或转移的验证标准）。然而，执行OPPV并非必须要有ATP，即使未应用完整的APLC框架，也可以实施程序性能监测计划。在这些情况下，验证标准可从现有的验证或系统适用性标准中得出。如果认为有用，生命周期方法的要素也可以追溯应用。
