2023.11-FDA批准后检查指南(中英文对照版)
目录PART I—BACKGROUND 6
部件 我-背景 .. 6
PART II—IMPLEMENTATION 9
部件 二-实施 .. 9
Scope 9
1. 范围 ... 9
Strategy 9
2. 战略 ... 9
Risk-Based Determination for Postapproval Inspections 9
A. 基于风险 测定 对于 批准后检查 ... 9
Inspection by Objective 10
B. 检查 通过目标 .. 10
Program Management Instructions11
3. 项目管理说明11...
Facility Selection11
A. 设施选择11....
Postapproval Inspection Assignment Requests11
B. 批准后检查分配请求11...
Inspection Scheduling and Preparation12
C. 检验计划和准备12..
Inspection Team13
D. 检查组13..
Expanding Inspection Coverage to Compliance Program 7356.00213
E. 将检查范围扩大到合规计划7356.00213..
CDER Consultation During Inspection13
F. 检查期间的CDER咨询13 ...
Refusals14
G. 拒绝14 ...
Importance of Application Assessment Integration14
4. 应用评估集成的重要性14...
PART III―INSPECTIONAL15
第三部分——检查15...
Inspection/Audit Strategy15
1. 检查/审计战略15 ....
Inspection/Audit Coverage, Objectives, and Techniques15
2. 检查/审计范围、目标和技术15 ...
Objective 1: Process Validation Lifecycle and State of Control16
A. 目标1：过程验证生命周期和控制状态16..
Objective 2: Investigations and CAPA Program22
B. 目标2：调查和CAPA计划22 ....
Objective 3: Change Management, Change Effectiveness, and Conformance to the Application and Other
Postmarketing Reports and Requirements24
C. 目标3：变更管理、变更有效性以及与应用程序和其他上市后报告和要求的一致性2
4
Objective 4: Integrity of Product Quality Data33
D. 目标4：产品质量数据的完整性33....
Inspection Reporting35
3. 检验报告35..
Issuance of Form FDA 48335
A. FDA 48335表格的发布....
Completion and Assessment of the Establishment Inspection Report35
B. 机构检查报告的完成和评估35....
Sample Collection or Sample Submission Requests36
4. 样品采集或样品提交请求36..
PART IV—ANALYTICAL37
第四部分-分析37 ...
PART V―REGULATORY / ADMINISTRATIVE STRATEGY38
第五部分——监管/行政战略38 ....
Significant Issues38
1. 重大问题38..
Coordination for Regulatory/Administrative Follow-Up Actions to Inspection Findings39
2. 协调检查结果的监管/行政后续行动39 ...
Issues That Are Considered Significant for PAC 5684339
A. PAC 5684339认为重要的问题 ..
Issues That Are Not Considered Significant for PAC 5684341
B. 对PAC 5684341不重要的问题 ..
PART VI—REFERENCES, ATTACHMENT, PROGRAM CONTACTS, AND ACRONYMS42
第六部分-参考文献、附件、项目联系人和缩写42 ....
References42
1. 参考文献42 ..
Code of Federal Regulations, Title 2142
A. 《联邦法规》，第2142篇..
Compliance Programs42
B. 合规计划42....
Compliance Policy Guide42
C. 合规政策指南42...
FDA Guidances43
D. FDA指南43....
Other Procedures and References44
E. 其他程序和参考44..
Attachment45
2. 附件45 ...
Program Contacts45
3. 程序联系人45....
Office of Regulatory Affairs45
A. 监管事务办公室45..
Center for Drug Evaluation and Research46
B. 药物评估与研究中心46...
Acronyms46
4. 缩略词46 ...
PART VII―OVERVIEW OF CDER-ORA RESPONSIBILITIES48
第七部分——CDER-ORA职责概述48 ...
ATTACHMENT A: REMOTE REGULATORY ASSESSMENTS49
附件A：远程监管评估49 ..
FDA Records and Other Information Requests Under Section 704(a)(4) of the FD&C Act (Statutorily Authorized
RRA)49
1. 《食品和药品管理法案》（法定授权RRA）第704（a）（4）节规定的食品和药品管理
局记录和其他信息请求49 ....
Remote Interactive Evaluation (Voluntary RRA)49
2. 远程交互评估（自愿RRA）49 ... 感谢分享！！ 谢谢分享 {:1_180:} {:1_180:}{:1_180:} 谢谢分享
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