USP Responses to Instrument Qualification Stimuli published for Comment

Since the beginning of May 2024, the stimuli document 'USP Responses to Comments for Stimuli Articles on Analytical Instrument and System (AIS) Qualification' has been published for comment on the USP Pharmacopeial Forum website. Comments and observations on this summary can be submitted until 31 July 2024.

This article summarises the responses and feedback from USP's Analytical Instrument and System Qualification (AISQ) Joint Subcommittee (JSC) to comments from three stimuli articles on the topic of instrument qualification. The comments were based on the following three stimuli articles published during 2022

  • SRP 1-Analytical Instrument and System (AIS) Qualification, to Support Analytical Procedure Validation over the Life Cycle 
  • SRP 2-Analytical Instrument and System (AIS) Qualification: The Qualification Life Cycle Process 
  • SRP 3-Measurement Uncertainty Evaluation Relevant to Analytical Instrument and System (AIS) Qualification-The Role of Measurement Uncertainty Concepts within the AIS

Most comments were submitted on the third stimuli article. These include comments and feedback (section 22-39) in the document currently being commented on. The two other stimuli articles SRP1 and SRP2 were also the subject of lively discussion and their responses were presented accordingly.

The discussions of the stimuli articles and the new comments are intended to support the revision of the monograph <1058> ANALYTICAL INSTRUMENT QUALIFICATION and represent the views of the individual interest groups. In order to obtain further information and input from the individual groups, the USP is also organising a workshop on this topic in June 2024.

The Stimuli document 'USP Responses to Comments for Stimuli Articles on Analytical Instrument and System (AIS) Qualification' can be viewed and commented on after a one-time registration on the Pharmacopeial Forum website.

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