Module 3 Presentations

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Front Page	1
M3 Agenda	2
Lecture 1: CMC in the Drug Development Programme	5
Lecture 2: API Manufacture and In-Process Controls	22
Lecture 3: Nomenclature and Characterisation of the Active Ingredient	37
Lecture 4: CMC Project Management	56
Lecture 5: Analytical Methods and Validation	76
Lecture 6: Developing Specifications for the Active Ingredient	92
Lecture 7: Pharmaceutical Development and Manufacture of the Drug Product	109
Lecture 8: Stability of the Drug product	126
Lecture 9: Pharmaceutical Packaging	153
Lecture 10: Good Manufacturing Practice	181
Lecture 11: Regulatory Agency Perspective	195

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