Overview Using the principles outlined in ICH Q3D and training modules we will: • Present a series of risk assessments based on actual products. •…
Category: QualityManagement
Automation is slowly taking over our lives, ranging from smart homes to self-driving cars. With experiments becoming ever more complex and datasets more immense, a…
The United States Pharmocopeia (USP) and the International Conference on Harmonisation (ICH) both specify limits for elemental impurities in drug products. The USP specifications are…
Purpose: To provide answers to questions that have been frequently asked of members of the ICH Q3D Expert Working Group. General FAQs 1. Why is…
TosupportthepracticalimplementationoftheInternationalCouncilforHarmonisation(ICH)Q3D guideline, which describes a risk-based approach to the control of elemental impurities in drug products, a consortium of pharmaceutical companies has established a database to collate…
Elemental impurities in drug products may arise from several sources; they may be residual catalysts that were added intentionally in synthesis or may be present as…
We have now passed the six month point before the Falsified Medicines Directive (FMD) comes into force. In this online exclusive, Mark Davison, senior operations director, rfxcel…
Volume 4 of “The rules governing medicinal products in the European Union” contains guidance for the interpretation of the principles and guidelines of good manufacturing…
Every government allocates a substantial proportion of its total health budget to medicines. This proportion tends to be greatest in developing countries, where it may…
1. Introduction 1.1 Medicines regulatory systems worldwide have always depended upon the knowledge of organizations that develop, manufacture and package, test, distribute and monitor pharmaceutical…