准备FDA认证前检查Preparing for FDA Preapproval Inspections中英文对照

History of Business企业历史
When was it founded? By whom? 什么时候成立？由谁创建？ Important milestones during company development 公司发展中的重要里程碑
Site changes 网站的变化 Addition of buildings, purchase of major equipment 此外还有建筑物，主要设备的采购 Product introductions 产品介绍
可能会要求更多的信息
Richard Needham, RFL Associates 5
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 (Laboratory Issues) FDA化验师（实验室问题） Generally, they will work separately 一般来说，他们将分开工作 Therefore, preparation for two people is needed 因此，需要配备两个人
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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。
The Company Presentation (30-45 minutes)

公司介绍（30-45分钟）


Importance of the Initial Presentation 初始表现很重要

It is FDA’s first impression of your company 这是FDA对该公司的第一印象 It should be very professional (graphics and presentation) 应该很专业 （图形和文稿） It should be in English 应当是英文的 It should not be too long (1 hour is too long) 不应该过长（不超过1小时） You should rehearse giving the presentation to make sure it is perfec 您应该提前演练您的演讲，保证他的完美
Richard Needham, RFL Associates
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Flow of the pre-Approval Inspection/Initial Meeting 认证前检查流程/首次会议


The Company Presentation (30-45 minutes)
公司介绍（30-45分钟）


Richard Needham, RFL Associates
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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
Richard Needham, RFL Associates 9
Flow of the pre-Approval Inspection 认证前检查流程
Initial Meeting (1-1 ½ hours)
首次会议（1 - 1个半小时）
Make sure that every person is identified by n10 1ame 确保每个人标注姓名
Preparing for FDA Preapproval Inspections 准备FDA认证前检查
Richard Needham, RFL Associates
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Purpose of a pre-Approval Inspection (DMF or ANDA)
认证前检查的目的（DMF或ANDA）
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
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
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
Name and title displayed at initial meeting 姓名和标题呈现在首次会议上 Name tags on uniform during inspection 检查期间所有姓名标签格式应统一 Consider also a handout with the following information for key people: 还考虑分发含有以下信息的资料给关键人员： Full name (and English surname if applicable) 全名（如果适用加上英文姓氏） Title 标题 Thumbnail photograph 照片缩图
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
Richard Needham, RFL Associates
做好出现意外的准备
Richard Needham, RFL Associates 8
Flow of the pre-Approval Inspection 认证前检查流程
Initial Meeting (1-1 1/2 hours)
首次会议（1 - 1个半小时）
Introductions and exchange of business cards 介绍并交换名片 The most responsible person at the firm should be present 该公司负责人应该在场 QA, Production, QC Representatives should be present QA，生产，QC代表应该在场
Richard Needham, RFL Associates
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Flow of the pre-Approval Inspection 认证前检查
Inspection will usually take 4 full days 检查通常需要 4天 Initial Meeting (1- 1 ½ hours) 首次会议（1 - 1个半小时） Walkthrough of Warehouses, Production, QC Laboratory (5-6 hours) 仓库，生产，QC实验室巡检（5-6小时） Document Review (2-2 ½ days) 文件审查（2-2天半） Closeout (1-2 hours)总结（1-2小时） However, the FDA Inspectors may change this schedule 然而，FDA检查员可能会改变这个时间表 Be prepared for the unexpected
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
Richard Needham, RFL Associates 2
Purpose of a pre-Approval Inspection
认证前检验的目的

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
FDA will have initial questions and will request essential documents FDA会提出一些初始问题，并要求提供一些精 炼的文档
Richard Needham, RFL Associates 11
Flow of the pre-Approval Inspection/Initial Meeting 认证前检查流程/首次会议
Richard Needham, RFL Associates
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Flow of the pre-Approval Inspection 认证前检查
Initial Meeting (1-1 ½ hours)
首次会议（1 - 1个半小时）
Company Presentation 公司介绍
PowerPoint with hard copies provided 提供可以拷贝的PPT
Richard Needham, RFL Associates l Inspection 认证前检查流程
Preparation for two people generally means:
配备两个人通常是指
Two Interpreters (provided by the firm, at present) 两名翻译员（目前由公司提供的） The interpreters are extremely important to the smooth running of the inspection 翻译员对于检查顺利进行是非常重要的 Two adjacent conference rooms 两个相邻的会议室 Investigator 调查人员 Chemist化验师