USP Stimuli Article: Proceedings of the Analytical Lifecycle Workshop 2016

In Pharmacopeial Forum (PF) 43(6), November 2017, a stimuli article containing the Highlights of the US Pharmacopeia (USP) and ECA Academy Workshop on the Lifecycle Approach of Analytical Procedures held in Prague, Czech Republic, November 8–9, 2016, are summarized. The purpose of the workshop was to provide an overview of the lifecycle approach efforts by the USP Validation and Verification Expert Panel, US FDA, European Medicines Agency, and other experts in the field. The agenda included presentations on the development of analytical procedures, quality by design (QbD) processes, analytical control strategies, quality risk management (QRM) principles, validation, qualification, transfer, verification, and case studies. Some of the newer concepts discussed throughout the workshop included the analytical target profile (ATP), risk assessment, focus on the reportable value, use of decision rules, and replication strategies. Attendees provided feedback on the lifecycle approach.

Up to now, the USP Expert Panel has published four Stimuli articles in Pharmacopeial Forum (PF) on the Lifecycle Approach:

  • Lifecycle Management of Analytical Procedures: Method Development, Procedure Performance
    Qualification and Procedure Performance Verification in PF 39(5),
  • Fitness for Use: Decision Rules and Target Measurement Uncertainty in PF 42(2),
  • Analytical Target Profile. Structure and Application Throughout the Analytical Lifecycle in PF42(5),
  • Analytical Control Strategy in PF 42(5).

Additionally, a proposed new general chapter, The Analytical Procedure Lifecycle <1220>, was posted on the USP website ( and subsequently published in PF 43(1) [January 2017].

The purpose of the November 2016 USP Workshop was to discuss the approaches presented in the above mentioned PF articles with a diverse, international audience of more than 130 attendees. The concepts being proposed in the new chapter <1220> and the Stimuli articles were presented, along with examples and feedback from U.S. and European regulatory agencies. The consensus of the attendees was that there was significant interest in this approach and that it has the potential to add value to industry, but there may be challenges to overcome from regulatory and technical perspectives.

In 2017, the board of ECA’s Analytical Quality Control Group (AQCG) decided to support the lifecycle approach for analytical procedures by drafting a new Guideline on ‘Analytical Procedure Lifecyle Management‘ (APLM). In addition, this Draft Guideline was presented at a workshop conference in November in Vienna, where it was also discussed and reviewed and where input for the final version was collected.

After registration to the Pharmarcopeial Forum you get access to the complete stimuli article.

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