Investigational Medicinal Products - QP Module

Course overview

All QPs need to understand the different Good Manufacturing Practice (GMP) requirements for commercial and Investigational Medicinal Products (IMPs), and the unique additional GMP requirements for IMPs. This two day interactive course examines the EU legislation relevant to the manufacture, control and supply of IMPs. It provides practical guidance on the major differences in the GMP requirements between IMPs and commercial products, and the unique areas that QPs need to consider when releasing IMPs e.g. packaging and labelling processes and control.

Delegates will also benefit from the opportunity to learn about the principles of Good Clinical and Good Laboratory Practice, and how these relate to GMP for IMPs.

The course includes the following topics and reinforced using group exercises:

Day 1

• Methods and Equipment including Virtual Tour of Chemical facilities
• Methods and Equipment for Bio APIs
• GMP Requirements for API’s-Eudralex Vol 4
• GMP Requirements FMD and GDP
• GMP Requirements ICH and Impurities
• MCQ on Part II

Day 2

• Registration Aspects including QP declaration
• Laboratory Controls
• Process validation overview
• Cleaning validation overview
• Understanding the Supply Chain and QP Responsibilities
• The Control of API Packaging Materials
• API Audit Situations

Prerequisites

The course is ideally suited for those wishing to ensure they have sufficient awareness of the specific nature of IMPs and the challenges facing the QP, and is suitable for QPs, Production and QA Staff working in IMP manufacture and supply.