Evolution of Analytical Procedure Validation Concepts: Part II

In parallel to the evolution of compendial and regulatory approaches addressing new quality paradigms for analytical procedure validation (discussed in Part I of this article), fundamentals of the quality-by-design (QbD) concept have been incorporated into the new International Council for Harmonisation (ICH) Q14 and ICH Q2(R2), which were recently released for public consultation. 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.

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: 22–29

Citation

When referring to this article, please cite it as Guiraldelli, A. and Weitzel, J. Evolution of Analytical Procedure Validation Concepts: Part 2. BioPharm International Quality and Regulatory Sourcebook 2023. March 2023.