Prequalification: Training material

Training course

Workshop on GMP and Quality Assurance of TB products including Bioequivalence issues
Kuala Lumpur, Malaysia
21 – 25 February 2005

Agenda [doc]

Presentations:

• General Overview and Procedures [ppt]

• Research and development [ppt]

• Dossier requirements [ppt]

• Experience with prequalification of dossiers [ppt]

• Active pharmaceutical ingredients (APIs) [ppt]

• Stability studies (emphasis on FPPs) [ppt]

• Personnel [ppt]

• Premises [ppt]

• GMP Documentation: Part 1 | Part 2 [ppt]

• Equipment [ppt]

• Materials [ppt]

• HVAC:  Part 1 | Part 2 | Part 3 [ppt]

• Quality Control Laboratory [ppt]

• Validations: Part 1 | Part 2 | Part 3 | Part 4 | Part 5 [ppt]

• Evaluation of bioavailability/bioequivalence data [ppt]

• Marketing authorization of pharmaceutical products with special reference to multisource (generic) products: a manual for drug regulatory authorities: 
  Multisource (Generic) Pharmaceutical Products - Guidelines on Registration Requirements to Establish Interchangeability [ppt]

• Experience from the evaluation of drug dossiers with respect to bioequivalence [ppt]