Insights

GxP Compliant Monitoring

Documentation and Computerized Systems Regulations

This article will give you an insight of 21 CFR Part 11 & EU GMP Annex 11 and how they are used within the Cold Chain Temperature Monitoring....

GxP Compliant Monitoring

Pharma GxP for Beginners

Getting started within the Pharma GxP can be quite overwhelming. Most important is to get an overview of what GxP is all about. This article gives...

Cold Chain in Transport

Mean Kinetic Temperature (MKT): Definition, Calculation & Use

Learn what Mean Kinetic Temperature (MKT) is, how it’s calculated, and why it’s critical for pharmaceutical stability studies, storage, and GDP...