BRIEFING

 〈1058〉 Analytical Instrument Qualification. This chapter is based on the version of the chapter official as of August 1, 2017. General chapter 〈1058〉 was originally published in 2008 and last revised in 2017. Since 2008, there have been important improvements that must be addressed, including Analytical Procedure Life Cycle 〈1220〉 and increased awareness of the need for continuous monitoring and control to ensure compliance.

 General chapter 〈1058〉 is unique in the regulatory sector. It is widely regarded and used globally by regulators, suppliers, and industry. It provides a framework for establishing “fitness for intended use” of apparatus, analytical instruments, and systems.

 Given the structure of current chapter 〈1058〉, the Chemical Analysis Expert Committee considered it appropriate to restructure rather than just amend it. Life cycle approaches are recommended and the 4Qs model will be maintained although it has some weaknesses. These are addressed to avoid confusion and highlight nomenclature misunderstandings. Some of the existing content is reused or repositioned.

 In addition, there are two new general chapters in preparation for a future issue of PF: Process Analytical Technology—Theory and Practice 〈1037〉 and Ongoing Procedure Performance Verification 〈1221〉. Chemometrics 〈1039〉 and Good Documentation Guidelines 〈1029〉 on good documentation practice and data integrity are in revision.

 Another reason for rewriting this chapter is the intent for above 〈1000〉 general chapters to provide general guidance for stakeholders. It is important to put “what needs to be done” in the context of “why it needs to be done”. The decision of “how it needs to be done” is the prerogative of individual organizations.

 This proposed revision is based on three Stimuli to the Revision Process articles (SRPs):

 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]

 (GCM: E. Biba)

 Case ID—SUB-1755