There were 10 participants in total from Vietnam and the Philippines. The content of training course was mainly focused on 4 functions of NRA system on quality management of vaccine, in which NICVB has 2: Lot Release (LR) and Laboratory Access (LA). As the lecturers had cautiously selected for the training: the qualified experts from World Health Organization (WHO), National Institute of Infectious Diseases (NIID), Pharmaceuticals and Medical Devices Agency (PMDA) etc. this course was highly appreciated. In particular, NICVB staffs had a chance to observe and learn several quality control tests carried out at Japanese vaccine manufacturing facilities such as BIKEN, BCG, Kitasato Daiichi Sankyo.

The training course began from general issues namely , Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Quality Management System (QMS) to more specific methods: quality control of BCG, DPT, Influenza, Measles, Polio etc. vaccines. Throughout the lessons, NICVB’s staffs became more adept of the relevance of quality management system, and managed to apply the acquired valuable knowledge in conformity with actual conditions of their Institute and their country context. During the training course, participants had a good occasion to openly exchange shortcomings together whereas lecturers explained and provided necessary information and materials for doing research & development (R&D) along with accomplishing new quality control tests.

The output targets for the trainees were to build up the annual development programme (ADP) and the monitoring plan for their own unit. To figure out this effectively, participants were divided into groups and practiced to build up plans in line with each function that their facility in charge; based on the actual difficulties and shortcomings in the Institute, they had to propose suitable directions and plans to overcome these issues. After a group drafted their ideas onto papers and spent time discussing together, they received the recommendations from other groups and the lecturers to complete the final report on their country’s ADP - which was the final result of the session.

This training course ended with flying colours: Japanese experts are very satisfied with trainees’ studying spirit and compliance of internal rules while participants acquired useful knowledge for their professional work. NICVB ’s staffs still consult Japanese experts from NIID after returning to Vietnam, in order to continue exchanging experience to improve testing… NICVB hopes that JICA, Japan will continue to support our technical staffs to advance their capacity of performing quality control tests of vaccines and biologicals, in attempt to approach the world’s development in the preventive medicine field.

(Nguyen Phuong Lien – Quality Control of Bacterial Vaccine Department)