GMP Compliance: Introduction
If you hold an establishment licence, or run an operation governed by Part C, Division 2 of the Food and Drug Regulations, you must make sure that you comply with GMP requirements and the marketing or clinical trial authorization when you fabricate, package, label, import, distribute, test and wholesale drugs. You must not place consumers at risk because of poor safety, quality, efficacy, or for not complying with regulations.
Bio-Pharma Organizations are responsible for meeting the requirements outlined in the Regulations and clarified in GMP guidance. You will also need the help and commitment of your suppliers and personnel at all levels of your establishment.
- Understand the basics of Good Manufacturing Practices for medicinal products for human use and the current legal regulations and guidelines;
- Have the confidence to outline the main GMP requirements related to premises, storage facilities and personnel;
- Get familiar with the principles of the GMP quality system and quality control and the important procedures when dealing with complaints and recalls;
- Regulatory agencies around the world
- FDA, MHRA/EMEA, TGA , PIC/S
- Health Canada
- What does GXP mean?
- What do you think?
- GMP solution
- GMP Works, Activities and processes
- Evolution of GMP
Anyone interested in GMP
– Training materials will be distributed
– A Certificate of Attendance will be issued to the participants who have attended the training course.
Kossi Molley, LSSBB, Chartered Trainer – Managing Consultant