准备FDA认证前检查中英文对照70页.pptVIP

Richard Needham, RFL Associates Preparing for FDA Preapproval Inspections准备FDA认证前检查 Purpose of a pre-Approval Inspection (DMF or ANDA)认证前检查的目的（DMF或ANDA） Ensure that the facilities, equipment, and instruments are suitable for producing a quality product 确保设施，设备和仪器适合高质量产品的生产 Ensure that the quality system is functioning correctly 确保质量体系运行正常 Ensure that product is manufactured under cGMPs 确保在cGMPs指导下进行产品生产 Purpose of a pre-Approval Inspection认证前检验的目的 Ensure that data submitted in the ANDA or DMF submission is supported by raw data at the facility 确保在ANDA或DMF文件中提交的数据以设施的原始数据为依据 Data and original records must be documented according to cGMP standards 原始数据和记录必须根据cGMP标准进行 Ensure that the ANDA or DMF submission is an accurate reflection of what is being done at the facility确保ANDA或DMF中提交的是设施正在进行的情况的准确反应 The Pre-Approval Inspection (PAI) 认证前检查（PAI） When is the DMF reviewed by FDA? DMF什么时候被FDA审查？ Only after the ANDA holder files the ANDA and refers to the DMF 只有在ANDA持有人将ANDA归档并提交到DMF后 If no ANDA is filed, the DMF is filed away without review. 如果ANDA没有归档，那么DMFjiang将其移开不进行审查。 However, the DMF holder should still update the DMF through annual reports and DMF amendments to the FDA 然而，DMF持有人仍应通过年度报告和DMF修订将更新提交给FDA This way, the DMF will be up-to-date when reviewed这样， DMF被审查时将是最新的 The Pre-Approval Inspection (PAI)认证前检查（PAI） When is the ANDA reviewed by FDA? FDA什么时候审查ANDA After the ANDA holder files the ANDA ANDA持有人将ANDA归档后 Because of backlogs, expect at least 6 month delay before reviewing 由于积压，预计至少延迟6个月才能被审查 When is the Inspection scheduled? 什么时候进行预先审查 After the ANDA is satisfactorily reviewed ANDA审查圆满后 Deficiency letter may be issued 信件缺乏可能成为问题 More information may be requested 可能会要求更多的信息 Flow of the pre-Approval Inspection认证前检查流程 FDA Personnel Involved FDA涉及人员 Two people are usually involved: 通常涉及两个人 FDA Investigator (Production issues) FDA调查人员（生产问题） FDA Chemist (Lab