OIE Workshop on Vaccine Quality and GLP in ASEAN Countries
(Bandung, Indonesia, 13-16 January 2009)
The objective of the Workshop was to provide national competent authorities with the updated information on the quality control of vaccines, including Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP).
The Workshop was attended by 38 participants who are involved in veterinary vaccine quality control (two from each ASEAN member country: one veterinary officer designated as the National Focal Point for Animal Vaccines as well as other veterinary medicinal products, and the other veterinary officer engaged in veterinary drug assay laboratory work), in their respective countries, observers from Indonesia and the OIE (Drs Francois Diaz and Michel Lombard from OIE Headquarters, Drs T. Fujita and Y. Sakurai from Regional Representation based in Tokyo); Drs Tomoaki Shimazaki and Ayako Morioka form the National Veterinary Assay Laboratory (NVAL), Ministry of Agriculture, Forestries and Fisheries, Japan, Prof. Dr. Widya Asmara from Gadjah Mada University and Dr Ni Made Ria Isriyanthi from National Veterinary Drug Assay Laboratory (NVDAL) of Indonesia as resource persons.
Dr T. Fujita, OIE Asia-Pacific, Dr Agus Heriyanto, Director of NVDAL, and Dr Tjeppy Soedjana, Director General of Livestock Services of Indonesia, delivered opening addresses. Dr T. Fujita welcomed the participants, lecturers and observers, and explained the aims of the Workshop as well as the importance of animal vaccine quality in line with international standards. Dr Agus Heriyanto introduced the background of the Workshop and stressed the importance of updated Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) to ensure the quality of veterinary vaccines. Dr Tjeppy Soedjana officially declared the opening of the Workshop.
General Lectures were made on (i) Livestock Development, Animal Health, Veterianry Drug Administration and Quality Control in Indonesia by Dr Agus Wiyono, Directorate General of Livestock Services (DGLS) of Indonesia, (ii) Background and Purpose of ASEAN Standard of Animal Vaccine by Dr Agus Heriyanto, NVDAL-Indonesia, (iii) OIE standards on vaccine production by Drs F. Diaz and M. Lombard, and on (iv) Introduction of VICH activities to Asian countries by T. Shimazaki, NVAL-Japan.
After those general lectures, quality control of veterinary vaccines, especially on GMP and GLP in Japan, was presented by Dr A. Morioka, NVAL-Japan, and Indonesian standard of vaccine production, focusing on microbial agent contained in vaccines, was presented by Prof. Dr. Widya Asmara, Gadjah Mada University.
Each participating country from ASEAN reported its current situation on vaccine production and quality control systems especially concerning GMP and GLP.
A presentation on GMP and GLP for veterinary vaccine production in Indonesia was made by Dr Ni Made Ria Isriyanthi as a reference for drafting ASEAN standards and followed by discussions. During the discussions, the Workshop proposed firstly to revise the existing Manual of ASEAN Standards for Good Manufacturing Practices (GMP) for Animal Vaccines. In this regard, the discussions in the Workshop focused on revising the structure of the Manual of ASEAN Standards for GMP for Animal Vaccines, referring to the Chapter 1.1.8 of the OIE Terrestrial Manual and the Indonesian standards in a complementary manner.
Between discussions, field trips were made to pharmaceutical companies (Sanbe/Caprifarmindo and Medion) which were producing animal vaccines in Bandung.
On the last day, discussions on draft conclusions and recommendations were made. The Workshop recognised that animal vaccines are useful only when they are manufactured in compliance with international standards and also when properly distributed, stored, handled and used in an effective way, and that some of regional standards for registration and quality control of animal vaccines which have been developed in ASEAN countries need to be reviewed, to be in line with the regular updates of international standards.
The Workshop recommended the Manual of ASEAN Standards for GMP for Animal Vaccines should be reviewed and revised in accordance with international standards. Indonesia, as the ASEAN Focal Point for Animal Vaccines, will circulate the draft revised during the Workshop and the comments from ASEAN Member Countries will be collated and tabled for discussions at the next Meeting of National Focal Points for Animal Vaccines which will be held in Indonesia, tentatively in April 2009.
The Workshop also recommended that ASEAN Member Countries should continue to collaborate within the Region and to continue cooperation with international organizations in order to establish the harmonization of ASEAN Standards for Animal Vaccines. This cooperation should also include application(s) by the ASEAN Animal Vaccine Testing Laboratories for the OIE Certified Laboratory Twinning Project.
The full text of conclusions and recommendations is attached (PDF).