Course Scope:
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.
Overview:
At the end of the course you will:
•Understand the requirements of Directives 2001/20/EC and 2005/28/EC
•Appreciate the unique nature of many aspects of IMP manufacture
•Be aware of the GMPs relevant to IMPs – including Annex 13
•Be aware of the principles of GCP and GLP and how these relate to IMP manufacture
Who should attend:
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.
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.
Overview:
At the end of the course you will:
•Understand the requirements of Directives 2001/20/EC and 2005/28/EC
•Appreciate the unique nature of many aspects of IMP manufacture
•Be aware of the GMPs relevant to IMPs – including Annex 13
•Be aware of the principles of GCP and GLP and how these relate to IMP manufacture
Who should attend:
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.
