Analytical procedure performance can be continually verified by risk-based monitoring of performance related data.
Jane Weitzel
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Articles by Jane Weitzel
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.
This article provides an overview of validation concept principles evolution to a life cycle risk-based approach with focus on compendial perspectives.
This article provides an overview of the key risks that can be associated with the use of secondary reference standards (RS) and illustrates scientific challenges associated with transitioning from pharmacopeial RS to secondary RS.
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Latest Updated Articles
- Evolution of Analytical Procedure Validation Concepts: Part I – Analytical Procedure Life Cycle and Compendial Approaches
Published: November 4th 2022 | Updated:
Ongoing Analytical Procedure Performance Verification—Stage 3 of USP<1220>Published: March 2nd 2023 | Updated:
The Value of Pharmacopeial Reference StandardsPublished: February 3rd 2021 | Updated:
- Evolution of Analytical Procedure Validation Concepts: Part II– Incorporation of Science and Risk-based Principles in ICH Q14 and Q2(R2) Guidelines
Published: December 20th 2022 | Updated:
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