Good Manufacturing Practice (GMP) for APIs

4 April 2011, Nottingham, United Kingdom

Introduction

A fundamental grasp of GMP requirements is a critical asset. This one day course provides an overview of the current EudraLex Volume 4, Part II GMP regulations as applied to Active Substances used as starting Materials in Medicinal Products for Human and Veterinary use. A practical exercise is included to discuss common deficiencies noted by EMA, MRHA and FDA during regulatory inspections.