Quality and Regulatory Sourcebook eBook March 2023
Read the article:
Evolution of Analytical Procedure Validation Concepts: Part II
Read Part I:
Evolution of Analytical Procedure Validation Concepts: Part I
Read the eBook:
Evolution of Analytical Procedure Validation Concepts: Part II
Publication
Article
BioPharm InternationalBioPharm 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.
Worawut - Stock.adobe.com
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.
Articles in this issue
Mitigating Human Error and Supporting Compliance with Smart Technology
Phase-appropriate Analytical Methodology
Evolution of Analytical Procedure Validation Concepts: Part II
Pharmacovigilance Automation
Evolution of Analytical Procedure Validation Concepts: Part I
Points to Consider for Knowledge Management Acceleration
Recent Videos
Related Content
EMA Recommends Imfinzi-Based Perioperative Regimen for Treating Resectable NSCLC
March 10th 2025Article
The committee’s recommendation is based on results from a Phase III trial in which Imfinzi demonstrated a reduced risk of recurrence, progression, or death by 32% compared to neoadjuvant chemotherapy alone.
