
Analytical procedure performance can be continually verified by risk-based monitoring of performance related data.

Analytical procedure performance can be continually verified by risk-based monitoring of performance related data.

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.

Published: November 4th 2022 | Updated:

Published: March 2nd 2023 | Updated:

Published: February 3rd 2021 | Updated:

Published: December 20th 2022 | Updated: