C6B: GMP Requirements for Medicinal Cannabis Manufacture
Tracks
Eureka Room 2&3 Breakout 2
| Wednesday, November 20, 2024 |
| 11:00 AM - 11:30 AM |
Details
Medicinal Cannabis manufacture is increasing in Australia and around the world. GMP plays an important role in ensuring product quality evidenced by the inclusion of GMP requirements in the latest update to TGO93. As new players enter the market, there is a need to continue education and awareness on the importance of GMP for these products. This session will focus on the key considerations of GMP for medicinal cannabis products as well as common deficiencies that inspectors are observing during inspections of both Australian and overseas manufacturers.
Speaker: Maurice Makdessi, Senior GMP Inspector & Team Leader, Inspections Section
Maurice joined the TGA in 2009, he is currently a team leader in the Inspections section. He has science, engineering and management qualifications to masters level and has over 20 years’ experience in the Pharmaceutical industry and held management posts in quality assurance, quality control, production, and R&D at multinational companies in Australia and Overseas. He contributed to research work in teams developing synthetic active pharmaceuticals and finished dose formulations. He also worked earlier on, in forensic toxicology in research, developing analytical methods for quantitation of drug of abuse residue and trace elements in blood and tissue samples.
Speaker: Maurice Makdessi, Senior GMP Inspector & Team Leader, Inspections Section
Maurice joined the TGA in 2009, he is currently a team leader in the Inspections section. He has science, engineering and management qualifications to masters level and has over 20 years’ experience in the Pharmaceutical industry and held management posts in quality assurance, quality control, production, and R&D at multinational companies in Australia and Overseas. He contributed to research work in teams developing synthetic active pharmaceuticals and finished dose formulations. He also worked earlier on, in forensic toxicology in research, developing analytical methods for quantitation of drug of abuse residue and trace elements in blood and tissue samples.
