Proposed Update to USP <1058> on Analytical Instrument and System Qualification

In the Pharmacopeial Forum, PF 51(2), a proposed revision of the existing USP Chapter <1058> Analytical Instrument Qualification has been published for comments.

The informational chapter provides general guidance in a scientific, risk-based approach for carrying out an analytical instrument and system qualification (AISQ). In the introduction, it says that "AISQ is not a single event but an assurance journey over the entire operational life cycle of the instrument or system from specification and qualification to retirement."

The proposal is based on the version of the chapter official as of 01 August 2017. However, as mentioned in the briefing notes, "the Chemical Analysis Expert Committee considered it appropriate to restructure rather than just amend it." This is based on three Stimuli to the Revision Process articles, which we have also reported on:

• Analytical Instrument and System (AIS) Qualification, to Support Analytical Procedure Validation over the Life Cycle, published in PF 48(1)
• Measurement Uncertainty Evaluation Relevant to Analytical Instrument and System (AIS) Qualification—The Role of Measurement Uncertainty Concepts within the AIS, published in PF 48(2)
• Analytical Instrument and System (AIS) Qualification: The Qualification Life Cycle Process, published in PF 48(5)

In this context, it is also proposed to rename the chapter to <1058> Analytical Instrument and System Qualification.

The draft is available free of charge after registration via the USP website access point. Comments can be submitted until 31 May 2025.

Document Contents

The new proposal is structured into the following main chapters:

• 1. Introduction
• 2. <1058> Interrelationships with other USP General Chapters
• 3. Life Cycle Processes for Qualification and Validation
• 4. Risk Assessment to Establish Extent of Qualification and Validation Activities 
• 5. Life Cycle Models for Qualification and Validation in AISQ
• 6. Calibration in Establishing “Fitness for Intended Use” of Instruments and/or Systems
• 7. Change Control over the Life Cycle
• 8. Roles and Responsibilities over the Life Cycle

4Qs Model vs. Three-Stage Approach

Qualification is often subdivided into four stages:

• Design Qualification (DQ)
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)

The briefing notes of the proposed revision mention that this commonly used "4Qs model will be maintained although it has some weaknesses." However, as described in detail in subchapter 5.2 of the new proposal "the 4Qs model for AIS qualification should be integrated into the more general life cycle model and thus aligned with the analytical procedure life cycle and the process validation life cycle." This model has the following three stages:

• Stage 1: Specification and selection of the apparatus or instrument and/or system
• Stage 2: Installation, performance qualification, and validation
• Stage 3: Ongoing performance verification

The advantages and disadvantages of these approaches are also described in the Guide for an Integrated Lifecycle Approach to Analytical Instrument Qualification and System Validation developed by the ECA Analytical Quality Control Group (AQCG).