BioPharm International - March 2023

BioPharm International - March 2023

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22 BioPharm International ® Quality and Regulatory Sourcebook March eBook 2023 www.biopharminternational.com I n parallel to the evolution of compendial and regulatory approaches addressing new quality paradigms for analytical procedure validation (discussed in Part I of this article), funda- mentals of the quality-by-design (QbD) concept have been incorporated into the new Internation- al Council for Harmonisation (ICH) Q14 and ICH Q2(R2), which were recently released for public con- sultation. This article focuses on drawing parallels between ICH Q14/Q2(R2), United States Pharmaco- peia (USP) <1220>, and International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025:2017. ICH Q14 Draft Guideline: Analytical Procedure Development In March 2022, the ICH Q14 draft guideline was pub- lished for public consultation aiming to describe science- and risk-based approaches for developing and maintaining analytical procedure suitable for assessing the quality of chemical and biological/bio- technological drug substances and drug products (1). ICH Q14 considers the application of QbD principles to the development and analy tical procedure life cycle (APLC) management based on the systematic approach suggested in ICH Q8, together with princi- ples described in ICH Q9. One of the most significant sections for industry is chapter 7, "Lifecycle Management and Post-Approval Changes of Analytical Procedures", which mentions severa l elements for A PLC ma nagement, i n l i ne with Q12. Examples are established conditions (EC), post-approval change management protocols (PAC- MPs), product life cycle change management (PLCM), and pharmaceutical quality system (PQS). In addition, Q14 introduces the elements method operable design region (MODR) and analytical target profile (ATP), which support the industry in apply- ing the enhanced approach and may facilitate reg- ulator y communication of post-approval changes Evolution of Analytical Procedure Validation Concepts: Part II Amanda Guiraldelli, is Scientific Affairs Manager, United States Pharmacopeia. Jane Weitzel is an Independent Consultant and Chair of the US Pharmacopeia Expert Committee on Measurement and Data Quality. This article focuses on drawing parallels between ICH Q14/Q2(R2), United States Pharmacopeia (USP) <1220>, and International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025:2017. WORAWUT - STOCK.ADOBE.COM

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