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[FDA药事] 本人有大量法规文件--愿与人交换(优先交换没有的,法规目录见附表)

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发表于 2017-11-16 09:13:26 | 显示全部楼层 |阅读模式
本人有大量法规类文件愿与人交换,交换原则:
1、优先交换本人没有的;
2、中文版本也可交换;
3、优秀的法规类文件可以根据评分交换法规数量;
4、当我收齐所需,可无私分享大家一部分;
5、非诚勿扰。

序号
法律法规名称
生效日期
颁布单位
法规分类
备注
其他
1
1.Active Pharmaceutical Ingredients (Second Edition) - Revision to Bulk Pharmaceutical Chemicals
活性药物成分(第二版)---对散装药用化学品的修订
2007
ISPE
Baseline® Guides
 
2
2.Oral Solid Dosage Forms (Second Edition)
口服固体制剂(第二版)
2009
ISPE
Baseline® Guides
 
3
3.Sterile Product Manufacturing Facilities (Second Edition)
无菌药品生产设施(第二版)
2011
ISPE
Baseline® Guides
 
4
4.Water and Steam Systems (Second Edition)
水和蒸汽系统(第二版)
2011
ISPE
Baseline® Guides
 
5
5.Commissioning and Qualification
调试与确认
2001
ISPE
Baseline® Guides
 
6
6.Biopharmaceutical Manufacturing Facilities (Second Edition)
生物药品生产设施(第二版)
2003
ISPE
Baseline® Guides
 
7
7.Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP)
基于风险的药品生产(风险MAPP
2010
ISPE
Baseline® Guides
 
8
GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems
GAMP 5: 保证GXP计算机系统符合性的基于风险的方法
2008
ISPE
GAMP®
 
9
A Risk-Based Approach to Calibration Management (Second Edition)
基于风险的校验管理方法
 
ISPE
GAMP® Good Practice Guides
 
10
A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems (Second Edition)
基于风险的GXP符合性实验室计算机化系统方法
 
ISPE
GAMP® Good Practice Guides
 
11
A Risk-Based Approach to GxP Process Control Systems (Second Edition)
基于风险的GXP过程控制系统(第二版)
 
ISPE
GAMP® Good Practice Guides
 
12
A Risk-Based Approach to Operation of GxP Computerized Systems
GXP
计算机化系统操作的风险管理方法
 
ISPE
GAMP® Good Practice Guides
 
13
A Risk-Based Approach to Regulated Mobile Applications
基于风险的移动APP管理方法
 
ISPE
GAMP® Good Practice Guides
 
14
A Risk-Based Approach to Testing of GxP Systems (Second Edition)
基于风险的GXP系统检测方法(第二版)
 
ISPE
GAMP® Good Practice Guides
 
15
Electronic Data Archiving
电子数据归档
 
ISPE
GAMP® Good Practice Guides
 
16
Global Information Systems
全球信息系统
 
ISPE
GAMP® Good Practice Guides
 
17
IT Infrastructure Control and Compliance
IT基础设施控制和符合性
 
ISPE
GAMP® Good Practice Guides
 
18
Legacy Systems
遗留系统
 
ISPE
GAMP® Good Practice Guides
 
19
Manufacturing Execution Systems – A Strategic and Program Management Approach
生产执行系统策略和编程管理方法
 
ISPE
GAMP® Good Practice Guides
 
20
Risk-Based Approach to Electronic Records and Signatures
基于风险的电子记录和签名方法
 
ISPE
GAMP® Good Practice Guides
 
21
Applied Risk Management for Commissioning and Qualification
调试和确认中的风险管理
 
ISPE
ISPE Good Practice Guides
 
22
Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems (Second Edition)
制药用水和蒸汽系统调试和确认方法(第二版)
2008
ISPE
ISPE Good Practice Guides
 
23
Assessing the Particulate Containment Performance of Pharmaceutical Equipment (Second Edition)
制药设备颗粒密闭性能的评估(第二版)
 
ISPE
ISPE Good Practice Guides
 
24
Booklet Labels
书册标签
 
ISPE
ISPE Good Practice Guides
 
25
Clinical Supply Systems
临床补给系统
 
ISPE
ISPE Good Practice Guides
 
26
Cold Chain Management
冷链管理
 
ISPE
ISPE Good Practice Guides
 
27
Comparator Management
对照组管理
 
ISPE
ISPE Good Practice Guides
 
28
Development of Investigational Therapeutic Biological Products
临床前治疗用生物产品开发
 
ISPE
ISPE Good Practice Guides
 
29
Good Engineering Practice优良工程规范
2008
ISPE
ISPE Good Practice Guides
 
30
Harmonizing the Definition and Use of Non-Investigational Medicinal Products (NIMPs)
协调非临床前药品的定义和使用
 
ISPE
ISPE Good Practice Guides
 
31
HVAC
 
ISPE
ISPE Good Practice Guides
 
32
Interactive Response Technology
互动反馈技术
 
ISPE
ISPE Good Practice Guides
 
33
Maintenance
维护
 
ISPE
ISPE Good Practice Guides
 
34
Ozone Sanitization of Pharmaceutical Water Systems
制药用水系统的臭氧消毒
 
ISPE
ISPE Good Practice Guides
 
35
Packaging, Labeling, and Warehousing Facilities
包装、贴标和仓储设施
 
ISPE
ISPE Good Practice Guides
 
36
Process Gases
工艺用气
 
ISPE
ISPE Good Practice Guides
 
37
Project Management for the Pharmaceutical Industry
制药行业的项目管理
 
ISPE
ISPE Good Practice Guides
 
38
Quality Laboratory Facilities
质量实验室设施
 
ISPE
ISPE Good Practice Guides
 
39
Technology Transfer (Second Edition)
技术转移(第二版)
2003
ISPE
ISPE Good Practice Guides
 
40
Biopharmaceutical Process Development and Manufacturing
生物药品工艺开发与生产
 
ISPE
ISPE Guides
 
41
Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment
基于风险的设施、系统和设备传送科学方法
 
ISPE
ISPE Guides
 
42
1.Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control Revised 2007 (Published 1980)
湿热灭菌工艺验证:循环设计、研发、确认和持续控制,修订2007
2007
PDA
PDA TR
 
43
3.Validation of Dry Heat Processes Used for Depyrogenation and Sterilization Revised 2013 (Published 1981) 01003 43506
用于除热源和灭菌的干热工艺验证,修订2013
2013
PDA
PDA TR
 
44
4Design Concepts for the Validation of Water-for-Injection Systems 1983
注射用水系统验证的设计概念,1983
1983
PDA
PDA TR
 
45
5.Sterile Pharmaceutical Packaging: Compatibility and Stability 1984无菌制剂包装:相容性和稳定性,1984
1984
PDA
PDA TR
 
46
7.Depyrogenation 1985
除热源,1985
1985
PDA
PDA TR
 
47
9.Review of Commercially Available Particulate Measurement Systems 1988
商业可采购的颗粒物检测系统审核,1988
1988
PDA
PDA TR
 
48
10. Parenteral Formulations of Proteins and Peptides: Stability and Stabilizers 1988
蛋白质和多肽注射制剂:稳定性和稳定剂,1988
1988
PDA
PDA TR
 
49
11. Sterilization of Parenterals by Gamma Radiation 1988
静脉注射伽马辐射灭菌,1988
1988
PDA
PDA TR
 
50
12. Siliconization of Parenteral Drug Packaging Components 1988
静脉注射剂药品包装组分硅化处理,1988
1988
PDA
PDA TR
 
51
13. Fundamentals of an Environmental Monitoring Program Revised 2014 (Published 1990)
环境监测计划原则,修订2014
2014
PDA
PDA TR
 
52
14. Validation of Column-Based Chromatography Processes for the Purification of Proteins Revised 2008 (Published 1992)
蛋白纯化用柱色谱工艺验证,修订2008
2008
PDA
PDA TR
 
53
15. Validation of Tangential Flow Filtration in Biopharmaceutical Applications Revised 2009 (Published 1992)
生物制药用正切流过滤验证,修订2009
2009
PDA
PDA TR
 
54
16. Effect of Gamma Irradiation on Elastomeric Closures 1992
人造橡胶塞伽马辐射效应,1992
1992
PDA
PDA TR
 
55
17. Current Practices in the Validation of Aseptic Processing -- 1992 1993
无菌工艺验证现行规范,19921993
1993
PDA
PDA TR
 
56
18. Report on the Validation of Computer-Related Systems 1995
计算机相关系统验证报告,1995
1995
PDA
PDA TR
 
57
19. Rapid/Automated ID Methods Survey 1990
快速/自动ID方法调查,1990
1990
PDA
PDA TR
 
58
20. Report on Survey of Current Industry Gowning Practices 1990
行业现行更衣规范调查报告,1990
1990
PDA
PDA TR
 
59
21. Bioburden Recovery Validation 1990
生物负载回收率验证,1990
1990
PDA
PDA TR
 
60
22. Process Simulation for Aseptically Filled Products Revised 2011 (Published 1996)
无菌灌装药品工艺模拟,修订2011
2011
PDA
PDA TR
 
61
23. Industry Survey on Current Sterile Filtration Practices 1996
现行无菌过滤实践行业调查,1996
1996
PDA
PDA TR
 
62
24. Current Practices in the Validation of Aseptic Processing – 1996 1996
无菌工艺验证现行规范,1996
1996
PDA
PDA TR
 
63
25. Blend Uniformity Analysis: Validation and In-Process Testing 1997
混合均一性分析:验证和中控测试,1997
1997
PDA
PDA TR
 
64
26. Sterilizing Filtration of Liquids Revised 2008 (Published 1998)
液体无菌过滤,修订2008
2008
PDA
PDA TR
 
65
27. Pharmaceutical Package Integrity 1998
药品包装完整性,1998
1998
PDA
PDA TR
 
66
28. Process Simulation Testing for Sterile Bulk Pharmaceutical Chemicals Revised 2006 (Published 1998)
无菌散装药用化学物工艺模拟测试,修订2006
2006
PDA
PDA TR
 
67
29. Points to Consider for Cleaning Validation Revised 2012 (Published 1998)
清洁验证的考虑要点,修订2012
2012
PDA
PDA TR
 
68
30. Parametric Release of Pharmaceuticals and Medical Device Products Terminally Sterilized by Moist Heat Revised 2012 (Published 1999)
最终湿热灭菌的药物和医疗器械参数放行,修订2012
2012
PDA
PDA TR
 
69
31. Validation and Qualification of Computerized Laboratory Data Acquisition Systems 1999
计算机化实验室数据获取系统验证和确认,1999
1999
PDA
PDA TR
 
70
32. Auditing of Suppliers Providing Computer Products and Services for Regulated Pharmaceutical Operations Revised 2004 (Published 1999)
提供受法规管理的药物操作用计算机产品和服务的供应商审计,修订2004
2004
PDA
PDA TR
 
71
33. Evaluation, Validation and Implementation of Alternative and Rapid Microbiological Methods Revised 2013 (Published 2000)
替代性和快速微生物方法的评估、验证和实施,修订2013
2013
PDA
PDA TR
 
72
34. Design and Validation of Isolate Systems for the Manufacturing and Testing of Health Care Products 2001保健药品的生产和检测分离系统的设计和验证,2001
2001
PDA
PDA TR
 
73
35. A Proposed Training Model for the Microbiological Function in the Pharmaceutical Industry 2001
制药行业微生物功能培训模式建议,
2001
2001
PDA
PDA TR
 
74
36. Current Practices in the Validation of Aseptic Processing – 2001 2002
无菌工艺验证的现行规范--2001
2002
2002
PDA
PDA TR
 
75
38. Manufacturing Chromatography Systems Post-Approval Changes: (ChromPAC):Chemistry, Manufacturing and Controls Documentation 2006
批准后生产用色谱系统:研发、生产和控制文件,2006
2006
PDA
PDA TR
 
76
39. Guidance for Temperature-Controlled Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment 2007
温度受控药物指南:通过运输环境来维护对温度敏感的药物的质量,2007
2007
PDA
PDA TR
 
77
40. Sterilization Filtration of Gases 2005
气体的无菌过滤,2005
2005
PDA
PDA TR
 
78
41. Virus Filtration 2008
病毒过滤,2008
2008
PDA
PDA TR
 
79
42. Process Validation of Protein Manufacturing 2005
蛋白质生产的工艺验证,2005
2005
PDA
PDA TR
 
80
43. Identification and Classification of Nonconformities in Molded and Tubular Glass Containers for Pharmaceutical Manufacturing Revised 2013 (Published 2007)
药物生产用模型制备和管式玻璃容器的识别和分类,修订
2013
2013
PDA
PDA TR
 
81
44. Quality Risk Management for Aseptic Processes 2008
无菌工艺的质量风险管理,2008
2008
PDA
PDA TR
 
82
45. Filtration of Liquids Using Cellulose-Based Depth Filters 2008
使用纤维素基础深层过滤器的液体过滤,2008
2008
PDA
PDA TR
 
83
46. Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to the End User 2009
最终里程:给最终用户的药物优良销售规范指南,2009
2009
PDA
PDA TR
 
84
47. Preparation of Virus Spikes Used for Virus Clearance Studies 2010
用于病毒清除研究的病毒加标样制备,2010
2010
PDA
PDA TR
 
85
48. Moist Heat Sterilizer Systems: Design, Commissioning, Operation, Qualification and Maintenance 2010
湿热灭菌系统:设计、调试、运行、确认和维护,2010
2010
PDA
PDA TR
 
86
49. Points to Consider for Biotechnology Cleaning Validation 2010
生物制品清洁验证考虑要点,
2010
2010
PDA
PDA TR
 
87
50. Alternative Methods for Mycoplasma Testing 2010
支原体测试替代性方法,2010
2010
PDA
PDA TR
 
88
51. Biological Indicators for Gas and Vapor-Phase Decontamination Processes: Specification, Manufacture, Control and Use 2010
气体和蒸汽相除污染工艺生物指示剂:质量标准、生产、控制和使用,
2010
2010
PDA
PDA TR
 
89
52. Guidance Good Distribution Practices for the Pharmaceutical Supply Chain 2011
药品供应链优良销售规范指南,2011
2011
PDA
PDA TR
 
90
53. Guidance for Industry: Stability Testing to Support Distribution of New Drug Products 2011
行业指南:支持新药销售的稳定性测试,2011
2011
PDA
PDA TR
 
91
54. Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations 2012
药品和生物制品生产操作的质量风险管理实施,
2012
2012
PDA
PDA TR
 
92
54-2. Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operation: Annex 1: Case Study Examples for Quality Risk Management in Packaging and Labeling 2013
药品和生物制品生产操作的质量风险管理实施,附录1:包装和标识中的质量风险管理案例研究,2013
2013
PDA
PDA TR
 
93
54-3. Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations Annex 2: Case Studies in the Manufacturing of Pharmaceutical Drug Products 2013
药品和生物制品生产操作的质量风险管理实施,附录2:药品生产中的质量风险管理案例研究,
2013
2013
PDA
PDA TR
 
94
54-4. Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations Annex 3: Case Studies in the Manufacturing of Biotechnological Bulk Drug Substances 2015
药品和生物制品生产操作的质量风险管理实施,附录3:生物散装药用物质生产中的质量风险管理案例研究,
2013
2013
PDA
PDA TR
 
95
55. Detection and Mitigation of 2,4,6-Tribromoanisole and 2,4,6-Trichloroanisole Taints and Odors in the Pharmaceutical and Consumer Healthcare Industries 2012
药物和保健行业中246-三溴苯甲醚和246-三氯苯甲醚污染和气味的检测和移除,2012
2012
PDA
PDA TR
 
96
56. Application of Phase-Appropriate Quality Systems and CGMP to the Development of Therapeutic Protein Drug Substance 2012
治疗用蛋白质药用物质研发中与阶段相适当的质量体系和CGMP应用,2012
2012
PDA
PDA TR
 
97
57. Analytical Method Validation and Transfer for Biotechnology Products 2012
生物制品的分析方法验证和转移,2012
2012
PDA
PDA TR
 
98
58. Risk Management for Temperature-Controlled Distribution 2012
温度受控销售风险管理,
2012
2012
PDA
PDA TR
 
99
59. Utilization of Statistical Methods for Production Monitoring 2012
生产监测用统计学方法使用,
2012
2012
PDA
PDA TR
 
100
60. Process Validation: A Lifecycle Approach 2013
工艺验证:生命周期方法,2013
2013
PDA
PDA TR
 
101
61. Steam In Place 2013
就地蒸汽,2013
2013
PDA
PDA TR
 
102
62. Recommended Practices for Manual Aseptic Processes 2013
人工无菌工艺规范建议,2013
2013
PDA
PDA TR
 
103
63. Quality Requirements for the Extemporaneous Preparation of Clinical Trial 2013
临床试验临时制备药物的质量要求,2013
2013
PDA
PDA TR
 
104
64. Active Temperature-Controlled Systems: Qualification Guidance 2013
在用温度控制系统:确认指南,2013
2013
PDA
PDA TR
 
105
65. Technology Transfer 2014
技术转移,2014
2014
PDA
PDA TR
 
106
66. Application of Single-Use Systems in Pharmaceutical Manufacturing 2014
药物生产中单次使用系统的应用,2014
2014
PDA
PDA TR
 
107
67. Exclusion of Objectionable Microorganisms from Nonsterile Pharmaceuticals, Medical Devices, and Cosmetics 2014
非无菌药物、医疗器械和化妆品中致病菌排除,2014
2014
PDA
PDA TR
 
108
68. Risk-Based Approach for Prevention and Management of Drug Shortages 2014
基于风险的药品存贮预防和管理,2014
2014
PDA
PDA TR
 
109
Product Quality Lifecycle Implementation® (PQLI®) Guide: Overview of Product Design, Development and Realization: A Science- and Risk-Based Approach to Implementation
药品质量生命周期实施指南(PQLI):产品设计、开发及实践的综述-一种科学的基于风险的实施方法
 
ISPE
PQLI Guides
 
 
110
Product Quality Lifecycle Implementation® (PQLI®) from Concept to Continual Improvement
Part 1: Product Realization using QbD, Concepts and Principles
从概念到持续改进的药品质量生命周期实施(PQLI)第一部分:利用质量源于设计(QbD),概念和原则实现产品
 
ISPE
PQLI Guides
 
 
111
Product Quality Lifecycle Implementation® (PQLI®) from Concept to Continual Improvement
Part 2: Product Realization using QbD, Illustrative Example
从概念到持续改进的药品质量生命周期实施(PQLI)第二部分:利用质量源于设计(QbD),实例解说实现产品
 
ISPE
PQLI Guides
 
 
112
Product Quality Lifecycle Implementation® (PQLI®) from Concept to Continual Improvement
Part 3: Change Management System as a Key Element of a Pharmaceutical Quality System
从概念到持续改进的药品质量生命周期实施(PQLI)第三部分:药品质量体系关键要素-变更管理
 
ISPE
PQLI Guides
 
 
113
Product Quality Lifecycle Implementation® (PQLI®) from Concept to Continual Improvement
Part 4: Process Performance and Product Quality Monitoring System (PP&PQMS)
从概念到持续改进的药品质量生命周期实施(PQLI)第四部分:工艺性能和药品质量监测体系(PP&PQMS
 
ISPE
PQLI Guides
 
 
114
Q1A(R2): Stability Testing of New Drug Substances and Products (Second Revision)新原料药和制剂的稳定性试验(第二版)
 
ICH
Quality
 
115
Q1B: Photostability Testing of New Drug Substances and Products新原料药和制剂的光稳定性试验
 
ICH
Quality
 
116
Q1C: Stability Testing for New Dosage Forms新制剂的稳定性试验
 
ICH
Quality
 
117
Q1D: Bracketing and Matrixing Designs for Stability Testing of Drug Substances and Drug Products原料药和制剂稳定性试验的交叉和矩阵设计
 
ICH
Quality
 
118
Q1E: Evaluation of Stability Data对稳定性数据的评估处理
 
ICH
Quality
 
119
Q1F: Stability Data Package for Registration Applications in Climatic Zones III and IV 在气候带IIIIV,药物注册申请所提供的稳定性数据
 
ICH
Quality
 
120
Q2A: Text on Validation of Analytical Procedures分析程序的验证
 
ICH
Quality
 
121
Q2B: Validation of Analytical Procedures: Methodology分析程序的验证:方法学
 
ICH
Quality
 
122
Q3A(R): Impurities in New Drug Substances (Revised Guideline)新原料药中的杂质(修订版)
 
ICH
Quality
 
123
Q3B(R): Impurities in New Drug Products (Revised Guideline)新制剂中的杂质(修订版)
 
ICH
Quality
 
124
Q3C: Impurities: Guideline for Residual Solvents杂质:残留溶剂指南
 
ICH
Quality
 
125
Q3C(M): Impurities: Guideline for Residual Solvents (Maintenance)杂质:残留溶剂指南(修改内容)
 
ICH
Quality
 
126
Q4: Pharmacopoeias药典
 
ICH
Quality
 
127
Q4A: Pharmacopoeial Harmonisation 药典的协调
 
ICH
Quality
 
128
Q4B: Regulatory Acceptance of Pharmacopoeial Interchangeability药典互替在法规上的可接受性
 
ICH
Quality
 
129
Q5A: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin来源于人或者动物细胞系的生物技术产品的病毒安全性评估
 
ICH
Quality
 
130
Q5B: Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products生物技术产品的质量:源于重组DNA的蛋白质产品的生产中所用的细胞中的表达构建分析
 
ICH
Quality
 
131
Q5C: Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products生物技术产品的质量:生物技术/生物产品的稳定性试验
 
ICH
Quality
 
132
Q5D: Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products用于生产生物技术/生物产品的细胞底物的起源和特征描述
 
ICH
Quality
 
133
Q5E: Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process基于不同生产工艺的生物技术产品/生物产品的可比较性
 
ICH
Quality
 
134
Q6: Specifications for New Drug Substances and Products新原料药和制剂的质量规格
 
ICH
Quality
 
135
Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances质量规格:新原料药和新制剂的检验程序和可接收标准:化学物质
 
ICH
Quality
 
136
Q6B: Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products质量规格:生物技术/生物产品的检验程序和可接收标准
 
ICH
Quality
 
137
Q7: Good Manufacturing Practices for Pharmaceutical Ingredients活性药物成份的GMP
 
ICH
Quality
 
138
Q7A: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients活性药物成份的GMP指南
 
ICH
Quality
 
139
Q8: Pharmaceutical Development药物研发
 
ICH
Quality
 
140
Q9: Quality Risk Management质量风险管理
 
ICH
Quality
 
141
Q10: Pharmaceutical Quality System
药物质量体系
 
ICH
Quality
 
142
Q11 Developmentand manufacture of drug substances原料药的开发与制造
 
ICH
Quality
 
143
Basic Requirements for Medicinal Products
药品的基本需求
 
EU
Good manufacturing practice (GMP) Guidelines.
 
144
Basic Requirements for Active Substances used as Starting Materials
作为起始物料的活性物质的基本要求
 
EU
Good manufacturing practice (GMP) Guidelines.
 
145
Site Master File
工厂主文件
 
EU
GMP related documents
 
146
Q9 Quality Risk Management
Q9
质量风险管理
 
EU
GMP related documents
 
147
MRA Batch Certificate
MRA
批证书
 
EU
GMP related documents
 
148
Template for the 'written confirmation' for active substances exported to the European Union for medicinal products for human use
用于人用药品的活性物质出口到欧盟的“确认证书”模板
 
EU
GMP related documents
 
149
1Manufacture of Sterile Medicinal Products
无菌药品的生产
 
EU
Annexes
 
150
2Manufacture of Biological active substances and Medicinal Products for Human Use
人用生物药品的生产
 
EU
Annexes
 
151
3Manufacture of Radiopharmaceuticals
放射性药物的生产
 
EU
Annexes
 
152
4Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products
非免疫动物药品的生产
 
EU
Annexes
 
153
5Manufacture of Immunological Veterinary Medicinal Products
免疫动物药品的生产
 
EU
Annexes
 
154
6Manufacture of Medicinal Gases
医用气体的生产
 
EU
Annexes
 
155
7Manufacture of Herbal Medicinal Products
草本药品的生产
 
EU
Annexes
 
156
8Sampling of Starting and Packaging Materials
原材料和包装材料的取样
 
EU
Annexes
 
157
9Manufacture of Liquids, Creams and Ointments
液体、乳剂、膏剂的生产
 
EU
Annexes
 
158
10Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation
压力计量喷雾状吸入式式药剂的生产
 
EU
Annexes
 
159
11Computerised Systems (revision January 2011)
计算机系统
 
EU
Annexes
 
160
12Use of Ionising Radiation in the Manufacture of Medicinal Products
药品生产过程中电离辐射的应用
 
EU
Annexes
 
161
13Manufacture of Investigational Medicinal Products
研究用药品的生产
 
EU
Annexes
 
162
14Manufacture of Products derived from Human Blood or Human Plasma
来自于人体血液或血浆的药品生产
 
EU
Annexes
 
163
15Qualification and validation
确认和验证
 
EU
Annexes
 
164
16Certification by a Qualified person and Batch Release
资质人员签发证书和批放行
 
EU
Annexes
 
165
17Parametric Release
参数放行
 
EU
Annexes
 
166
19Reference and Retention Samples
对照品和留样
 
EU
Annexes
 
167
Guidelines on Good Distribution Practice of Medicinal Products for human Use
 
EU
GDP
 
168
21CFR210Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General
 
FDA
21 Code of Federal Regulations
 
169
VALIDATION OF ASEPTIC PROCESSES
2011.01.01
PIC/S
Guidance documents
PE 008-4
170
SITE MASTER FILE FOR SOURCE PLASMA ESTABLISHMENTS
2007.09.25
PIC/S
Site Master Files
PE 009-11
171
GOOD PRACTICES FOR COMPUTERISED SYSTEMS IN REGULATED GXP ENVIRONMENTS
2007.09.25
PIC/S
Guidance documents
PE 010-4
172
GUIDANCE ON PARAMETRIC RELEASE
2007.09.25
PIC/S
Guidance documents
PE 011-1
173
QA DISTRIBUTION ACTIVITIES FOR APIs - MAY 2010
2011.03.24
PIC/S
Q&A Documents
PI 002-3
174
GUIDE TO GOOD PRACTICES FOR THE PREPARATION OF MEDICINAL PRODUCTS IN HEALTHCARE ESTABLISHMENTS (PE 010-4)
2014.03.01
PIC/S
Guidance documents
PI 005-3
175
ISOLATORS USED FOR ASEPTIC PROCESSING AND STERILITY TESTING
2007.09.25
PIC/S
Guidance documents
PI 006-3
176
JOINT PIC/S-EMA CONCEPT PAPER ON THE REVISION OF ANNEX 1
2015.02.05
PIC/S
PIC/S GMP Guide
PI 007-6
177
PARTICIPATING AUTHORITIES & PARTNERS & (PRE)-APPLICANTS
2015.01.09
PIC/S
Inspectorates
PI 008-3
178
AIDE MEMOIRE ON GMP PARTICULARITIES FOR CLINICAL TRIAL PRODUCTS
2007.09.25
PIC/S
Aide-Memoires
PI 009-3
179
QA ON TRACEABILITY OF MEDICINAL GASES
2012.12.18
PIC/S
Q&A Documents
PI 010-4
180
PIC/S GMP GUIDE
2014.03.01
PIC/S
PIC/S GMP Guide
PI 011-3
181
PIC/S Guide to Good Distribution Practice (GDP) for Medicinal Products
2014.06.01
PIC/S
Guidance documents
PI 012-3
182
QUALITY SYSTEM REQUIREMENTS FOR PHARMACEUTICAL INSPECTORATES
2007.09.25
PIC/S
Inspectorates
PI 013-3
183
PIC/S GUIDE TO INSPECTIONS OF SOURCE PLASMA ESTABLISHMENTS AND PLASMA WAREHOUSES (INSPECTION GUIDE)
2007.09.25
PIC/S
Guidance documents
PI 014-3
184
STANDARD OPERATING PROCEDURE PIC/S INSPECTION REPORT FORMAT
2007.09.25
PIC/S
Inspectorates
PI 020-3
185
AIDE MEMOIRE ON INSPECTION OF BIOTECH
2007.09.25
PIC/S
Aide-Memoires
PI 021-2
186
AIDE MEMOIRE ON INSPECTION OF QUALITY CONTROL LABORATORIES
2007.09.25
PIC/S
Aide-Memoires
PI 023-2
187
AIDE-MEMOIRE INSPECTION OF UTILITIES
2007.09.25
PIC/S
Aide-Memoires
PI 024-2
188
AIDE-MEMOIRE ON MEDICINAL GASES
2007.09.25
PIC/S
Aide-Memoires
PI 025-2
189
AIDE-MEMOIRE ON PACKAGING
2009.01.13
PIC/S
Aide-Memoires
PI 028-1
190
AIDE-MEMOIRE ON THE INSPECTION OF APIS
2009.01.13
PIC/S
Aide-Memoires
PI 030-1
191
RECOMMENDATION ON STERILITY TESTING
2007.09.25
PIC/S
Guidance documents
PI 031-1
192
PIC/S RECOMMENDATION ON RISK-BASED INSPECTION PLANNING
2012.01.01
PIC/S
Guidance documents
PI 032-2
193
EXPLANATORY NOTES FOR PHARMACEUTICAL MANUFACTURERS ON THE PREPARATION OF A SITE MASTER FILE
2011.01.01
PIC/S
Site Master Files
PI 038-1
194
PROCEDURE FOR HANDLING RAPID ALERTS AND RECALLS ARISING FROM QUALITY DEFECTS
2011.01.01
PIC/S
Inspectorates
PI-037-1
195
TECHNICAL INTERPRETATION OF REVISED ANNEX 1 TO PIC/S GMP GUIDE
2010.01.08
PIC/S
Guidance documents
PS INF 06 2012 (Rev 1)
196
VALIDATION MASTER PLAN INSTALLATION AND OPERATIONAL QUALIFICATION NON-STERILE PROCESS VALIDATION CLEANING VALIDATION
2007.09.25
PIC/S
Guidance documents
PS INF 20 2011
197
STANDARD OPERATING PROCEDURE TEAM INSPECTIONS
2009.07.29
PIC/S
Inspectorates
PS W 01 2015
198
SITE MASTER FILE FOR PLASMA WAREHOUSES
2007.09.25
PIC/S
PIC/S GMP Guide
PS/INF 21/2002 (Rev 18)
199
AIDE MEMOIRE ON ASSESSMENT OF QRM IMPLEMENTATION
2012.03.26
PIC/S
Aide-Memoires
 
200
Bar Code Label Requirements
Questions and Answers
2011.08
FDACDER
Compliance
PI 019-3
201
COMPRESSED MEDICAL GASES
1989.12.01
FDACDER
Compliance
Final
202
Computerized Systems Used in Clinical Investigations
2007.05
FDACDER
Compliance
Final
203
Good Laboratory Practice Regulations Questions and Answers
1981.06.01
FDACDER
Compliance
Final
204
Marketed Unapproved Drugs
2011.09.19
FDACDER
Compliance
Final
205
Nuclear Pharmacy Guideline Criteria for Determining When to Register as a Drug Establishment
1984.05.01
FDACDER
Compliance
Final
206
Part 11, Electronic Records; Electronic Signatures — Scope and Application
2003.09.05
FDACDER
Compliance
Final
207
Prescription Drug Marketing Act — Donation of Prescription Drug Samples to Free Clinics
2006.03.14
FDACDER
Compliance
Final
208
Prescription Drug Marketing Act (PDMA) Requirements
2006
FDACDER
Compliance
Final
209
Review of FDA's Implementation of the Drug Export Amendments of 1986
1990.05.01
FDACDER
Compliance
 
210
Street Drug Alternatives
2000.04.03
FDACDER
Compliance
Final
211
21CFR211Current Good Manufacturing Practice for Finished Pharmaceuticals
 
FDA
21 Code of Federal Regulations
Final
212
Comparability Protocols -- Protein Drug Products and Biological Products -- Chemistry, Manufacturing, and Controls Information
2003.02.13
FDA
CMC
Draft
213
Current Good Manufacturing Practice for Phase 1 Investigational Drugs
2008.07.15
FDA
Compliance
Final
214
Current Good Manufacturing Practices for Medical Gases
2003.05.06
FDA
CGMP,Pharmaceutical Quality
Final
215
Expiration Dating of Unit-Dose Repackaged Drugs: Compliance Policy Guide
2005.05.31
FDA
CGMP,Pharmaceutical Quality
 
216
Formal Dispute Resolution_ Scientific and Technical Issues Related to Pharmaceutical CGMP
2006.01.12
FDA
Compliance
Draft
217
Good Laboratory Practice Regulations -- Questions and Answers
1981.06.01
FDA
Compliance
Final
218
guide to inspection of computerized systems in drug processing
药品生产中计算机处理系统的验证指南
1983
FDA
 
Final
219
Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality
2013.06.25
FDA
CGMP,Pharmaceutical Quality
Final
220
Immunogenicity-Related Considerations for the Approval of Low Molecular Weight Heparin for NDAs and ANDAs
2014.04.09
FDA
Compliance
Final
221
Interim Guidance for 3 Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act
 
FDA
Compliance
Final
222
Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production
2006.10.12
FDA
CGMP,Pharmaceutical Quality
Final
223
Marketed Unapproved Drugs;Compliance Policy Guide
2011.09.19
FDA
Compliance
Final
224
Part 11, Electronic Records, Electronic Signatures - Scope and Application
2003.09.05
FDA
Compliance
Final
225
Pharmaceutical Components at Risk for Melamine Contamination
2009.08.07
FDA
CGMP,Pharmaceutical Quality
Final
226
Possible Dioxin/PCB Contamination of Drug and Biological Products
1999.08.23
FDA
CGMP,Pharmaceutical Quality
Final
227
Preparation of Investigational New Drug Products (Human and Animal)
1992.11.01
FDA
CGMP,Pharmaceutical Quality
Final
228
Process Analytical Technology -- A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance
2004.10.04
FDA
CGMP,Pharmaceutical Quality
Final
229
Process Validation: General Principles and Practices
工艺验证:一般原则与规范
2011.01.25
FDA
CGMP,Pharmaceutical Quality
Final
230
Pyrogen and Endotoxins Testing: Questions and Answers
2012.06.28
FDA
CGMP,Pharmaceutical Quality
Final
231
Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations
2006.10.02
FDA
CGMP,Pharmaceutical Quality
Draft
232
Sterile Drug Products Produced by Aseptic Processing
2004.10.04
FDA
CGMP,Pharmaceutical Quality
Draft
233
Testing of Glycerin for Diethylene Glycol
2007.05.02
FDA
CGMP,Pharmaceutical Quality
Draft
234
The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 - Good Manufacturing Practice (CGMP)
2010.01.27
FDA
CGMP,Pharmaceutical Quality
 



补充内容 (2017-11-16 14:08):
大家快来换啊

补充内容 (2017-11-17 15:06):
留下邮箱,分享一部分给你
回复

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药徒
发表于 2017-11-20 13:57:40 | 显示全部楼层
不知道是不是最新的版本,冷链运输的管理。

GPG; Cold Chain Management 2011.pdf

6.37 MB, 下载次数: 231, 下载积分: 金币 -1

点评

roadman  https://www.ouryao.com/thread-309512-1-1.html  发表于 2017-11-20 16:46
回复 支持 2 反对 0

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药徒
发表于 2017-11-16 10:43:23 | 显示全部楼层
集齐以后就可以迎娶白富美、出任CEO、走上人生癫疯了
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药徒
发表于 2018-1-4 17:07:34 | 显示全部楼层
21 Applied Risk Management for Commissioning and Qualification
调试和确认中的风险管理   ISPE 怎么分享?
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药徒
发表于 2017-11-20 11:47:00 | 显示全部楼层
看了半天,只找到一个楼主没有的,惭愧。还是楼主的资料多。想交你这个朋友,发个邮箱给你,以后各方面方便交流。楼主方便的话可以发几个PDA后面出的技术报告给我。38513038@qq.com

[muchong.com]ISPE工艺气体验证指南2011.pdf

5.39 MB, 下载次数: 561, 下载积分: 金币 -1

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roadman  https://www.ouryao.com/thread-309568-1-1.html  发表于 2017-11-20 16:44
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发表于 2017-11-18 13:23:03 | 显示全部楼层
再增加个PDA TR69   也分享一些给我吧,邮箱kkxl1986@aliyun.com

PDA-TR69-Bioburden-and-Biofilm-Management-in-Pharmaceutical-Manufacturing-Operations.pdf

9.69 MB, 下载次数: 382, 下载积分: 金币 -1

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roadman  中文:https://wenku.baidu.com/view/eb6a845e0029bd64793e2cb0.html  发表于 2017-11-20 16:39
roadman  图片OCR,有点模糊。https://wenku.baidu.com/view/07f6c79dddccda38366bafd6.html  发表于 2017-11-20 16:38
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药生
发表于 2017-11-16 10:17:03 | 显示全部楼层
给楼主点个赞,能分享吗?如果只是以交换资源的方式交流。那你集齐这些的路会有点漫长。如果广大蒲友都把自己有的分享一些出来,众志成城,相信很快就会齐了。

点评

阿炳1987  说的太对了!支持!  详情 回复 发表于 2017-11-16 14:44
回复 支持 1 反对 0

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药徒
发表于 2017-11-16 09:18:23 | 显示全部楼层
赤裸裸的炫耀,拉仇恨。

羡慕嫉妒恨啊!!!!
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 楼主| 发表于 2017-11-16 09:22:28 | 显示全部楼层
hoover 发表于 2017-11-16 09:18
赤裸裸的炫耀,拉仇恨。

羡慕嫉妒恨啊!!!!

别急,我收齐了,会有你的一份的
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药徒
发表于 2017-11-16 09:27:33 | 显示全部楼层
炫富……


论坛发金币帖子任意门
https://www.ouryao.com/forum.php? ... &fromuid=295574
论坛秘笈:每周赚1000积分不再是神话
https://www.ouryao.com/forum.php? ... &fromuid=295574
新手30分钟赚取200积分标准操作规程
https://www.ouryao.com/forum.php? ... &fromuid=295574
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 楼主| 发表于 2017-11-16 09:33:12 | 显示全部楼层

先富带后富,大家都会有的
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药徒
发表于 2017-11-16 09:34:17 | 显示全部楼层
厉害了,我的蒲友
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发表于 2017-11-16 09:36:25 | 显示全部楼层
我怎么 感觉我都没有
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药生
发表于 2017-11-16 09:36:52 | 显示全部楼层
主要是不想看,看了也用不到
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发表于 2017-11-16 09:44:33 | 显示全部楼层
英文不好,潇洒路过
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药徒
发表于 2017-11-16 09:55:33 | 显示全部楼层
求集齐,求分享,万分感谢
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药徒
发表于 2017-11-16 10:12:49 | 显示全部楼层
顶,厉害了!!!!!!!
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药徒
发表于 2017-11-16 10:20:35 | 显示全部楼层
666,首先是没有,再者就是英文盲
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 楼主| 发表于 2017-11-16 10:23:45 | 显示全部楼层
wuqi 发表于 2017-11-16 10:20
666,首先是没有,再者就是英文盲

英文不好,我给你换中文版的,到时候多送你几篇中文的
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药徒
发表于 2017-11-16 10:35:40 | 显示全部楼层
我想要的,你都缺,我们没法愉快的玩耍
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 楼主| 发表于 2017-11-16 10:36:59 | 显示全部楼层
270681282 发表于 2017-11-16 10:35
我想要的,你都缺,我们没法愉快的玩耍

没事,我帮你换,留下邮箱,有了分享给你
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 楼主| 发表于 2017-11-16 10:54:28 | 显示全部楼层
DK1024 发表于 2017-11-16 10:43
集齐以后就可以迎娶白富美、出任CEO、走上人生癫疯了

借你吉言了。。。。。。。
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 楼主| 发表于 2017-11-16 12:29:51 | 显示全部楼层
xxr041210 发表于 2017-11-16 10:12
顶,厉害了!!!!!!!

.........................

点评

阿炳1987  警告!本论坛禁止纯表情、标点符号等毫无意义的回帖!  详情 回复 发表于 2017-11-16 14:44
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发表于 2017-11-16 12:54:05 | 显示全部楼层
楼主好人,先分享一部分给我学习一下吧,574835048@qq.com
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