Production, assessment, and regulation of vaccines

Abstract: Developed countries have regulatory processes in place to guarantee the safety and efficacy of animal vaccines. Thus it is usual to inspect and regulate the premises used for vaccine production in addition to the manufacturing process, and the labeling and use of vaccines. Label claims must be fully supported by experimental data, including the results of field trials. Rigorous quality assurance controls are imposed on the organisms and antigens, the adjuvants, and excipients used in these products. For example, it is absolutely necessary that extraneous infectious agents be excluded and that genetically modified organisms do not pose an environmental threat.