Christopher Burgess, M. L. Jane Weitzel, Jean-Marc Roussel, Oscar Quattrocchi, Joachim Ermer, Rostyslaw Slabicky, Gabriel Vivó-Truyols

Correspondence should be addressed to: Edmond Biba, Senior Principal Scientist, US Pharmacopeia, 12601 Twinbrook Parkway, Rockville, MD 20852-1790; tel: 1.240.221.2072; email: EXB@usp.org.

This article is the response of USP's Analytical Instrument and System Qualification (AISQ) Joint Subcommittee (JSC) to comments on three Stimuli to the Revision Process (SRP) articles:

SRP 1—Analytical Instrument and System (AIS) Qualification, to Support Analytical Procedure Validation over the Life Cycle in PF 48(1) [Jan.–Feb. 2022]

SRP 2—Analytical Instrument and System (AIS) Qualification: The Qualification Life Cycle Process in PF 48(5) [Sep.–Oct. 2022]

SRP 3—Measurement Uncertainty Evaluation Relevant to Analytical Instrument and System (AIS) Qualification—The Role of Measurement Uncertainty Concepts within the AIS in PF 48(2) [Mar.–Apr. 2022]

All analytical instruments and systems for compendial use need to be qualified as “fit for intended use” using the information provided in the currently official general chapter Analytical Instrument Qualification 〈1058〉. Qualifying the operation and performance of an analytical instrument or system is a critical part of a robust quality management system and is required in a current good manufacturing practice (GMP) environment. In pharmacopeial applications, the performance of an instrument or system directly impacts the data reported by establishing the reportable values of analytical test characteristics specified in a monograph.

For this reason, AISQ JSC, established in 2021, has considered possible enhancements to 〈1058〉 as well as the impacts on analytical instrumental technique chapters below 〈1000〉 and other general chapters, particularly Analytical Procedure Life Cycle 〈1220〉.