Makie H
National Veterinary Assay Laboratory, Ministry of Agriculture, Tokyo, Japan.
Rev Sci Tech. 1998 Aug;17(2):578-84. doi: 10.20506/rst.17.2.1114.
The activities of veterinary vaccine control laboratories are reviewed. The National Veterinary Assay Laboratory (NVAL) in Japan is used as an example to describe a quality control system for veterinary vaccines. Veterinary vaccine control laboratories conduct tests on veterinary vaccines and perform studies to improve test methods to ensure quality, efficacy and safety. The primary responsibility of the veterinary vaccine control laboratory is the assay of animal vaccines for national use. In addition, vaccine control laboratories perform activities for the distribution of reference products, examinations, inspection of other laboratories to ensure implementation of 'good laboratory practices', technical training and other duties prescribed by the Ministry of Agriculture. The NVAL and veterinary control laboratories from other countries have participated in the work of the International Co-operation on Harmonisation of Veterinary Medicinal Products (VICH) group initiated by the Office International des Epizooties to harmonise technical requirements for registration of veterinary vaccines.
对兽医疫苗控制实验室的活动进行了审查。以日本国家兽医检验实验室(NVAL)为例,描述了兽医疫苗的质量控制体系。兽医疫苗控制实验室对兽医疫苗进行检测,并开展研究以改进检测方法,确保疫苗的质量、效力和安全性。兽医疫苗控制实验室的主要职责是对供国内使用的动物疫苗进行检验。此外,疫苗控制实验室还负责参考产品的分发、检测、对其他实验室进行检查以确保“良好实验室规范”的实施、技术培训以及农业部规定的其他职责。NVAL以及其他国家的兽医控制实验室参与了由国际兽疫局发起的兽药产品协调国际合作(VICH)小组的工作,以协调兽医疫苗注册的技术要求。