DTP vaccine production for National Regulatory Authority (NRA) staff
Course on DTP vaccine production for National Regulatory Authority (NRA) staff at the National Institute of Public Health and the Environment (RIVM), The Netherlands
In collaboration with WHO/IVB and in support of their efforts for strengthening National Regulatory Authorities, RIVM is offering a short course on DTP vaccine manufacturing. The purpose of the course is to familiarize NRA staff from developing countries with backgrounds of and methodology in use for D/T/P bulk, final bulk and final lot production.
The course is primarily intended for NRA staff members in developing countries who are in charge of, or involved in, document control for licensing or batch release of DTP/DT/TT vaccines, imported as well as domestically produced. The number of participants is limited to ten (10).
This two-week course is based on processes currently executed at RIVM, with an introduction into the history and backgrounds of choices made in the past, and with a direct relation to WHO product requirements.
In addition to the theoretical aspects, time is devoted to visit GMP facilities for D/P/T bulk, DTP final bulk and final lot production. An important component of the course is direct participation in a small scale fermentation process to obtain an impression of the 'hands-on' experience of modern vaccine production according to GMP.
Emphasis will be on understanding why processes are executed the way they are, and on the effect that variations in those processes may have on product quantity and product quality. Questions raised by participants, based on their experience, will be extensively discussed. The course will be given by staff from RIVM and SVM involved in production, quality control, quality assurance and product release as well as from the Netherlands' National Control Laboratory.
A comprehensive course manual consisting of modules addressing specific topics will be handed out to the participants. Course topics include: process overviews, the preparation of seed material, preparation of media, cultivation, harvesting procedures, downstream processing, and final product formulation. Quality assurance aspects, including GMP, process validation, and inspections will be addressed throughout the course.
Course fee applies.
Further information about this course can be obtained from:
Prof. Dr B. A. M. Van der Zeijst
Director, Vaccine Division
National Institute of Public Health and the Environment (RIVM)
Bureau for International Cooperation
Antonie van Leeuwenhoeklaan, 9
P.O. Box 1
3720 BA Bilthoven
Tel: 31 30 274 2694
Fax: 31 30 274 4405
For further information about the Global Training Network on Vaccine Quality, 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