Good Manufacturing Practices
Course on Good Manufacturing Practices (GMP) for national regulatory staff
A programme of theoretical and practical training in good manufacturing practices for biologics.
The GMP course provides an overview of the framework and principles of GMP, and enables the trainee to visit a production facility and interact with staff.
Topics covered by the course include:
- Introduction to GMP: history, purpose, scope
- Protocols and documentation
- Validation of facilities, equipment, processes
- Production and in-process controls
- Personnel training
- Regulatory affairs department functions
- Quality control department functions
- Quality assurance department functions
- Raw materials control
- Animal care and use
The programme includes lectures, case studies, films, reading assignments and observation visits to the production facility. Trainees will have an opportunity to participate in an audit. Evaluation of trainees is informal; participants will be awarded a WHO certificate for successful completion of the programme. Training takes place from 9:00 to 4:30 hours, Monday to Friday, with free time on the weekends.
Countries and trainees are selected according to criteria established by WHO. Preference is given to individuals who have key roles in their institution. Applicants with strong technical, leadership and teaching skills are at an advantage, and an adequate command of English is important.
For further information please contact:
Dr Umit Kartoglü
World Health Organization
20, Avenue Appia
CH-1211 Geneva 27
Tel: 41 22 791 4972
Fax: 41 22 791 4384