Quality and Regulatory Sourcebook eBook March 2023
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Evolution of Analytical Procedure Validation Concepts: Part II
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Evolution of Analytical Procedure Validation Concepts: Part II
Published on:
Amanda Guiraldelli , Jane Weitzel
BioPharm International, BioPharm International Quality and Regulatory Sourcebook 2023, Volume 2023 eBook, Issue 1
Pages: 22–29
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.
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.
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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.
