BioPharm International - March 2023

BioPharm International - March 2023

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14 BioPharm International ® Quality and Regulatory Sourcebook March eBook 2023 I n recent years, regulatory agencies have placed an increased emphasis on pharmaceutical pro- cess understanding through adoption of qual- ity-by-design (QbD) principles by launching a series of initiatives to encourage the pharmaceu- tical 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 pharmacopoe- ias 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 pub- lic 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 valida- tion concept principles evolution with a focus on compendial perspectives (Part I) and draw a parallel between ICH Q14 and Q2(R2) and United States Phar- macopeia (USP) General Chapter <1220> and the ISO/ IEC 17025:2017 (Part II). Evolution of process validation concept: quality paradigm shifts in the pharmaceutical environment The new industrial revolution, "Industr y 4.0," has been leading to changes in the pharmaceutical indus- try ("Pharma 4.0"), where significant paradigm shifts have been occurring in the pharmaceutical quality environment to enable manufacturing moderniza- tion and innovation. These changes have significant implications for how we think about pharmaceutical quality. Regulators, industry, and standards-setting organizations are increasingly recognizing the need to rely more on risk-based and QbD approaches rather than ensuring quality solely by compliance-driven and quality-by-testing approaches (3). In this context, traditional validation practices are undergoing a Evolution of Analytical Procedure Validation Concepts: Part I 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. This article provides an overview of validation concept principles evolution to a life cycle risk-based approach with focus on compendial perspectives. SEWCREAM - STOCK.ADOBE.COM

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