Lifecycle management in pharmaceutical analysis: How to establish an efficient and relevant continued performance monitoring program

Publication date: Available online 19 December 2019Source: Journal of Pharmaceutical and Biomedical AnalysisAuthor(s): Joachim Ermer, Debora Aguiar, Annette Boden, Bei Ding, Daniel Obeng, Michael Rose, Julie VokrotAbstractIt is the objective of a systematic and holistic Quality-by-Design approach to demonstrate and ensure that an analytical procedure is fit for its intended purpose over its entire lifecycle. Such a lifecycle approach, as proposed for a new USP General Information Chapter includes the three stages Procedure Design and Development, Procedure Performance Qualification, and Continued Procedure Performance Verification, in alignment to manufacturing process validation. A decisive component of this approach is the Analytical Target Profile, which defines the performance requirements for the measurement of a Quality Attribute as the target for selection, development and optimization of the respective analytical procedures. Although the most benefit can be gained by a comprehensive Quality-by-Design approach establishing the Analytical Target Profile in the very beginning of a drug development project, it may also be established retrospectively for analytical procedures long in routine use, in order to facilitate future lifecycle activities such as continual improvements, transfers, monitoring and periodic performance evaluations.In contrast to the first two stages of the analytical lifecycle with usually limited amount of data, the Continued Procedure Performance Ve...
Source: Journal of Pharmaceutical and Biomedical Analysis - Category: Drugs & Pharmacology Source Type: research