FDA检查相关要求.pptVIP

RFL Associates Preparing for FDA Inspections Zhejiang Apolea Medical Technology Company January, 2009 Purpose of an ANDA (DMF) pre-Approval InspectionANDA（DMF）批准前检查的目的 Ensure that the facilities, equipment, and instruments are suitable for producing a quality product 确保厂房，设备和仪器适用于生产合格的产品 Ensure that the quality system is functioning correctly 确保质量体系准确运行 Ensure that product is manufactured under cGMPs 确保产品在cGMP条件下生产 Purpose of an ANDA (DMF) pre-Approval Inspection Ensure that data submitted in the ANDA/DMF submission is supported by raw data at the facility确保在递交的ANDA/DMF中的数据是依据工厂的原始数据的 Data and original records must be documented according to cGMP standards数据和原始记录必须根据cGMP标准记录存档 Ensure that the ANDA/DMF submission is an accurate reflection of what is being done at the facility 确保ANDA/DMF的递交是准确地反映工厂中所做的事情 The ANDA (DMF) Pre-Approval Inspection (PAI) ANDA（DMF）批准前检查（PAI） When is the ANDA reviewed by FDA? FDA什么时候审核ANDA？ After the ANDA holder files the ANDA 在ANDA持有者递交ANDA之后 Because of backlogs, expect at least 6 month delay before reviewing 由于文件积压，在审核之前一般至少有6个月的延迟 When is the Inspection scheduled? 什么时候安排检查？ After the ANDA is satisfactorily reviewed 在对ANDA审核满意之后 Deficiency letter may be issued 缺陷信可能已经发布 More information may be requested可能要求更多的信息 Flow of the pre-Approval Inspection批准前检查的流程 FDA Personnel Involved FDA涉及的相关人员 Two people are usually involved: 通常安排两个人 Investigator 调查员 Chemist 化学家 Generally, they will work separately 通常他们分开工作 Therefore, preparation for two people is needed 因此，需要准备两组人员 Flow of the pre-Approval Inspection Preparation for two people generally means: 两组人员的准备 Two Interpreters (provided by the firm, at present)两个翻译人员（目前由公司自己安排） The interpreters are extremely important to the smooth running of the inspection 翻译人员对于检查的顺利进行及其关键 Two adjacent conference rooms 相邻的两个会议室 Investigator 调查员 Chemist 化学家 Flow of the pre-Approval Inspection Inspection will usually