All analytical instruments and systems for compendial use must be qualified to be "fit for intended use" using the guidance provided in the currently official general chapter Analytical Instrument Qualification 〈USP 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 (CGMP) environment.
In pharmacopeial applications, the performance of an instrument or system directly impacts the data reported by establishing the reportable value of an analytical test characteristic specified in a monograph.
In an earlier Stimuli article, Analytical Instrument and System (AIS) Qualification to Support Analytical Procedure Validation over the Life Cycle, the overall aims and objectives of the Analytical Instrument and System Qualification Joint Subcommittee (AISQ JSC) to enhance 〈1058〉 were described.
The process presented in this article is not a formal proposal for revision of 〈1058〉, but rather a deeper dive into the current thinking and position of the AISQ JSC on analytical instrument qualification and its relationship to the analytical procedure life cycle management framework.
The AIS qualification process provides the procedural and metrological performance framework for an instrument or system with a maintained qualified state of control and calibration over its life cycle, in accordance with the operational ranges of measurement as specified in the user requirement specifications (URS).
However, the ultimate responsibility for assuring "fitness for use" of an AIS remains with the user.
Various stakeholders throughout the AIS qualification process need to be identified and should be selected so that the process is appropriately designed and controlled.
At the heart of this process flow is the risk assessment and traceability matrix.
A traceability matrix, which forms part of the final qualification report, is the mapping of each requirement in the URS to an operational procedure, document, or test with acceptance criteria so that all qualification activities are completed. It is clear that the extent of the qualification effort required to assure "fitness for use" depends both on the complexity of the AIS and, critically, the use to which it is being put within a specific laboratory environment.
Once a risk assessment has been completed, a detailed qualification process flow can be defined for the AIS risk category.
Not all stages of the life cycle need to be undertaken and the identifies stages should map to the risk assessment matrix.
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