Analytical Quality by Design Fundamentals and Compendial and Regulatory Perspectives

Mahr, Amanda Guiraldelli; Lourenço, Felipe Rebello; Borman, Phil J.; Weitzel, Jane; Roussel, Jean-Marc

doi:10.1007/978-3-031-31505-3_8

Cited by 1 publication

(2 citation statements)

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“…The APLC framework consists of the ATP and three stages, procedure design (stage 1), procedure performance qualification (stage 2), and ongoing procedure performance verification (stage 3). 5,9 The enablers of this approach, which are considered enhanced from the traditional approach, are knowledge of quality risk management (QRM) and application of sound scientific approaches. This allows for in-depth knowledge acquisition of the procedure.…”

Section: ■ Introductionmentioning

confidence: 99%

“…22 In addition, ongoing verification can be used to assess the impact of changes to analytical conditions, ensuring the modified procedure will produce reportable values that meet performance criteria that can be defined in an ATP and are fit-for-purpose. 5,8,9,22 It can also serve as a preventive measure by providing an early indication of potential performance issues or adverse trends, aiding in the identification of potential changes for the analytical procedure. The overall knowledge generated during stages 1 and 2 is used as a basis for the design of the routine monitoring plan to support performance verification.…”

Section: ■ Introductionmentioning

confidence: 99%

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

Borman,

Guiraldelli,

Weitzel

et al. 2024

Anal. Chem.

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The analytical procedure life cycle (APLC) provides a holistic framework to ensure analytical procedure fitness for purpose. USP's general chapter <1220> considers the validation activities that take place across the entire analytical procedure lifecycle and provides a three-stage framework for its implementation. Performing ongoing analytical procedure performance verification (OPPV) (stage 3) ensures that the procedure remains in a state of control across its lifecycle of use post validation (qualification) and involves an ongoing program to collect and analyze data that relate to the performance of the procedure. Knowledge generated during stages 1 (procedure design) and 2 (procedure performance qualification) is used as the basis for the design of the routine monitoring plan to support performance verification (stage 3). The extent of the routine monitoring required should be defined based on risk assessment, considering the complexity of the procedure, its intended purpose, and knowledge about process/procedure variability. The analytical target profile (ATP) can be used to provide or guide the establishment of acceptance criteria used to verify the procedure performance during routine use (e.g., through a system/sample suitability test (SST) or verification criteria applicable to procedure changes or transfers). An ATP however is not essentially required to perform OPPV, and a procedure performance monitoring program can be implemented even if the full APLC framework has not been applied. In these situations, verification criteria can be derived from existing validation or system suitability criteria. Elements of the life cycle approach can also be applied retrospectively if deemed useful.

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Section: ■ Introductionmentioning

confidence: 99%

Section: ■ Introductionmentioning

confidence: 99%