FDA国外药厂检查指南精要.docVIP

GUIDE(1)?TO INSPECTIONSOF FOREIGN PHARMACEUTICAL MANUFACTURERS BACKGROUND背景 There has been a significant increase in the number of foreign inspections of pharmaceutical manufacturing plants in the past few years. This trend is attributable mainly to the increase in the number of pre-approval inspections although the increase has been noted in other areas such as routine GMP inspections and compliance follow-up activities. Considering the resource-intensive nature of the foreign inspection program, it has become clear that effective and efficient inspectional coverage is crucial to the successful management of the program and that can be achieved only through maintenance of consistency and uniformity of inspection and enforcement activities. 在最近几年医药制造厂外检查数量显著增加。这一趋势主要是由增加的前置审批检查的次数虽然增加了在其他领域如日常GMP检查和合规性的后续活动记录。考虑到国外的检验程序的资源密集型的性质，它已成为明确的，有效的和高效的检查范围是该计划的成功管理的关键，只能通过一致性和均匀性检查和执法活动维护了。Whenever possible, the agency tries to utilize only highly qualified Investigators and Analysts for the foreign inspection program who have extensive experience in conducting drug inspections with demonstrated track records of working effectively in a tight time frame and under considerable pressure. However, it has become increasingly evident that a formal guidance is necessary to address the issues specific to the foreign drug inspection operations as the agency needs to broaden the cadre of personnel to meet the objective of the program. Through this guide, the agency strives to ensure that it continues to realize the consistency and the uniformity in the overall inspectional/enforcement activities and, furthermore, informs the prospective inspection staff of the differences in the foreign vs. domestic drug inspection programs. 只要有可能，该机构试图利用只有高素质的研究人员和分析师的外国检验程序，谁拥有的证明记录有效的在时间紧迫的工作和相当大的压力下进行药物检查的丰富经验。然而，它已成为越来越明显的正式指导的具体地址到国外药品检验操作机构需要拓宽人事干部满足项目目标的问题是必要的。通过这本指南，该机构致力于确保它继续实现一致性和整体检索/执法活动的均匀性，此外，通知在国外与国内药品检验程序差异的前瞻性检验人员。This guide was prepared by FDAs Office of Regulatory Affairs (ORA)