Evolution of Analytical Procedure Validation Concepts: Part I

In recent years, regulatory agencies have placed an increased emphasis on pharmaceutical process understanding through adoption of quality-by-design (QbD) principles by launching a series of initiatives to encourage the pharmaceutical industry to adopt QbD in the manufacturing process. A key component of this transformation is the evolution of validation concepts to a life cycle risk-based approach driven by analytical quality by design (AQbD) principles. Different pharmacopoeias have been developing compendial approaches to support the implementation of analytical procedure life cycle (APLC) risk-based approach. Additionally, the International Council for Harmonisation (ICH) released in March 2022 two draft guidelines for public consultation which outline QbD principles: ICH Q14 (procedure development) (1), and the ICH Q2(R2) (procedure validation) (2). In a series of two articles, the authors will provide an overview of the validation concept principles evolution with a focus on compendial perspectives (Part I) and draw a parallel between ICH Q14 and Q2(R2) and United States Pharmacopeia (USP) General Chapter <1220> and the ISO/IEC 17025:2017 (Part II).

Read the article in BioPharm International’s Quality and Regulatory Sourcebook March 2023

About the authors

Amanda Guiraldelli is scientific affairs manager at the United States Pharmacopeia.
Jane Weitzel is an independent consultant and chair of the US Pharmacopeia Expert Committee on Measurement and Data Quality.

Article details

BioPharm International
eBook: Quality and Regulatory Sourcebook 2023
March 2023
Pages: 14–21

Citation

When referring to this article, please cite it as Guiraldelli, A. and Weitzel, J. Evolution of Analytical Procedure Validation Concepts: Part I. BioPharm International Quality and Regulatory Sourcebook 2023. March 2023.