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An R-Based Landscape Validation of a Competing Risk Model

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Ongoing Analytical Procedure Performance Verification Using a Risk-Based Approach to Determine Performance Monitoring

Phil J Borman¹, Amanda M Guiraldelli¹, Jane Weitzel¹

¹US Pharmacopeia 12601 Twinbrook Pkwy, Rockville, Maryland 20851, United States.

Analytical Chemistry

|January 8, 2024

Summary

This summary is machine-generated.

The analytical procedure life cycle (APLC) framework ensures analytical procedures remain fit for purpose. Ongoing performance verification (OPPV) monitors procedures post-validation, using data from earlier stages for effective control.

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Area of Science:

Pharmaceutical Sciences
Analytical Chemistry
Quality Control

Background:

The analytical procedure life cycle (APLC) framework, detailed in USP general chapter <1220>, guides analytical procedure validation and use.
Ensuring analytical procedures remain fit for purpose throughout their lifecycle is critical in pharmaceutical quality control.

Purpose of the Study:

To describe the implementation of the APLC framework, focusing on ongoing analytical procedure performance verification (OPPV).
To highlight how knowledge from APLC stages 1 and 2 informs the design of OPPV in stage 3.
To explain the role of risk assessment and the analytical target profile (ATP) in defining OPPV requirements.

Main Methods:

Utilizing a three-stage framework for APLC implementation: procedure design, performance qualification, and ongoing performance verification.
Employing risk assessment to determine the extent of routine monitoring for OPPV.
Leveraging the analytical target profile (ATP) to establish acceptance criteria for performance verification.

Main Results:

OPPV (stage 3) ensures analytical procedures remain in a state of control post-validation through continuous data collection and analysis.
Routine monitoring plans for OPPV are designed based on knowledge gained during procedure design and qualification.
Verification criteria for OPPV can be derived from existing validation or system suitability tests, even without a fully applied APLC framework.

Conclusions:

The APLC framework provides a comprehensive approach to maintaining analytical procedure performance and ensuring fitness for purpose.
OPPV is a key component of the APLC, enabling continuous monitoring and control of analytical procedures.
Elements of the life cycle approach can be applied retrospectively to enhance existing procedures.