疫苗工艺验证

摘要

Process validation is not only legal and regulatory requirements for vaccine industry,but also important means of quality assurance and essential conditions for commercial production.With development of the vaccine industry as well as publication of the latest industry regulatory guidelines,process validation has been given new contents and related to all stages of the product life cycle.Based on the latest industry guidelines and some practical work experience,the latest contents and trends of process validation are reviewed in this article.%工艺验证不仅是法律法规对疫苗行业的要求,更是商业化生产的必要条件和产品质量保证的重要手段.随着疫苗行业的发展以及最新行业法规指南的发布,工艺验证工作被赋予了新的内容,开始与产品生命周期的各个阶段联系在一起.此文在最新行业法规和指南的基础上,结合部分实际工作经验,对工艺验证的最新内容和发展趋势进行综述.