Prequalification: Training material for GMP

Training course

Training Workshop on Pharmaceutical Quality, Good Manufacturing Practice with a Focus on Artemisinines.
Dar-es-Salaam - United Republic of Tanzania

Agenda [doc]

List of Participants [pdf]

Presentations:

• Expression of Interest and Prequalification Guidelines on Dossier Assessment [ppt]

• Pharmaceutical Quality Information Form (PQIF) - API [ppt]

• Stability Studies [ppt]

• Pharmaceutical Quality Information Form (PQIF) - FPP [ppt]

• Verification of Applicability of the Validated/Compendial API Analytical Method for the Final Formulation [ppt]

• Pharmaceutical Quality by Design and Development [ppt]

• Efficacy and Safety Issues [ppt]

• Why are Bioavailability/Bioequivalence Studies necessary? [ppt]

• Bioequivalence Studies for Antimalarials in the Prequalification Programme: Outcomes and Frequently Encountered Deficiencies [ppt]

• Bioequivalence Dossier Requirements for the Prequalification Programme [ppt]

• Guidelines and Tools Available: TRS 937 and the BTIF [ppt]

• Example of a BTIF for Artesunate Tablets [pdf]

• Statistical Considerations for Bioequivalence Studies [ppt]

• Choice of Comparator Products [ppt]

• Good Manufacturing Practice (production aspects, utilities, equipment, validation and data verification) [ppt]

• Good Manufacturing Practice (Quality Control)  [ppt]