As per USP <1220>, “Analytical procedure performance qualification” (APPQ) refers to all activities performed in APLC stage 2, conducted to confirm that the procedure is fit for its intended purpose, ...

Regulatory expectations and requirements continue to evolve to ensure the quality and safety of drug products. Over the last five years, we have seen increased focus during regulatory inspections ...

On March 7, 2024, FDA published two final guidance documents regarding analytical procedures in order to facilitate regulatory evaluations and flexibility in postapproval change management of ...

The purpose of this course is to provide candidates with some practical tools for validation - including qualification, process validation and analytical method validation. Validation is a regulatory ...

The purpose of this course is to provide candidates with some practical tools for validation - including qualification, process validation and analytical method validation. Validation is a regulatory ...

In the pharmaceutical industries, validation of analytical methods is a critical process that confirms the reliability and appropriateness of a method for its intended application. Method validation ...

In this article, the author modestly expresses his views on the use and understanding of linearity, a key parameter to be determined in analytical method validation in quality control laboratories (QC ...

Dublin, Jan. 18, 2024 (GLOBE NEWSWIRE) -- The "Analytical Methods Validation for FDA Compliance Drugs and Biologics" training has been added to ResearchAndMarkets.com's offering. This Analytical ...