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）

h4369323

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	有
2	2.Oral Solid Dosage Forms (Second Edition) 口服固体制剂（第二版）	2009	ISPE	Baseline® Guides	有
3	3.Sterile Product Manufacturing Facilities (Second Edition) 无菌药品生产设施（第二版）	2011	ISPE	Baseline® Guides	有
4	4.Water and Steam Systems (Second Edition) 水和蒸汽系统（第二版）	2011	ISPE	Baseline® Guides	有
5	5.Commissioning and Qualification 调试与确认	2001	ISPE	Baseline® Guides	有
6	6.Biopharmaceutical Manufacturing Facilities (Second Edition) 生物药品生产设施（第二版）	2003	ISPE	Baseline® Guides	有
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	有
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®	有
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	缺
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	缺
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	缺
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	缺
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	缺
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	缺
15	Electronic Data Archiving 电子数据归档		ISPE	GAMP® Good Practice Guides	缺
16	Global Information Systems 全球信息系统		ISPE	GAMP® Good Practice Guides	缺
17	IT Infrastructure Control and Compliance IT基础设施控制和符合性		ISPE	GAMP® Good Practice Guides	缺
18	Legacy Systems 遗留系统		ISPE	GAMP® Good Practice Guides	缺
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	缺
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	缺
21	Applied Risk Management for Commissioning and Qualification 调试和确认中的风险管理		ISPE	ISPE Good Practice Guides	缺
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	有
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	缺
24	Booklet Labels 书册标签		ISPE	ISPE Good Practice Guides	缺
25	Clinical Supply Systems 临床补给系统		ISPE	ISPE Good Practice Guides	缺
26	Cold Chain Management 冷链管理		ISPE	ISPE Good Practice Guides	缺
27	Comparator Management 对照组管理		ISPE	ISPE Good Practice Guides	缺
28	Development of Investigational Therapeutic Biological Products 临床前治疗用生物产品开发		ISPE	ISPE Good Practice Guides	缺
29	Good Engineering Practice优良工程规范	2008	ISPE	ISPE Good Practice Guides	有
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	缺
31	HVAC		ISPE	ISPE Good Practice Guides	有
32	Interactive Response Technology 互动反馈技术		ISPE	ISPE Good Practice Guides	缺
33	Maintenance 维护		ISPE	ISPE Good Practice Guides	缺
34	Ozone Sanitization of Pharmaceutical Water Systems 制药用水系统的臭氧消毒		ISPE	ISPE Good Practice Guides	缺
35	Packaging, Labeling, and Warehousing Facilities 包装、贴标和仓储设施		ISPE	ISPE Good Practice Guides	缺
36	Process Gases 工艺用气		ISPE	ISPE Good Practice Guides	缺
37	Project Management for the Pharmaceutical Industry 制药行业的项目管理		ISPE	ISPE Good Practice Guides	缺
38	Quality Laboratory Facilities 质量实验室设施		ISPE	ISPE Good Practice Guides	缺
39	Technology Transfer (Second Edition) 技术转移（第二版）	2003	ISPE	ISPE Good Practice Guides	有
40	Biopharmaceutical Process Development and Manufacturing 生物药品工艺开发与生产		ISPE	ISPE Guides	缺
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	缺
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	有
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	有
44	4，Design 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	有
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	有
46	7.Depyrogenation 1985 除热源，1985	1985	PDA	PDA TR	有
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	有
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	缺
49	11. Sterilization of Parenterals by Gamma Radiation 1988 静脉注射伽马辐射灭菌，1988	1988	PDA	PDA TR	有
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	有
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	有
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	有
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	有
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	有
55	17. Current Practices in the Validation of Aseptic Processing -- 1992 1993 无菌工艺验证现行规范，1992，1993	1993	PDA	PDA TR	缺
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	缺
57	19. Rapid/Automated ID Methods Survey 1990 快速/自动ID方法调查，1990	1990	PDA	PDA TR	有
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	缺
59	21. Bioburden Recovery Validation 1990 生物负载回收率验证，1990	1990	PDA	PDA TR	有
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	有
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	缺
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	有
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	有
64	26. Sterilizing Filtration of Liquids Revised 2008 (Published 1998) 液体无菌过滤，修订2008	2008	PDA	PDA TR	有
65	27. Pharmaceutical Package Integrity 1998 药品包装完整性，1998	1998	PDA	PDA TR	有
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	有
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	有
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	有
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	有
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	缺
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	有
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	有
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	缺
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	有
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	有
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	有
77	40. Sterilization Filtration of Gases 2005 气体的无菌过滤，2005	2005	PDA	PDA TR	有
78	41. Virus Filtration 2008 病毒过滤，2008	2008	PDA	PDA TR	有
79	42. Process Validation of Protein Manufacturing 2005 蛋白质生产的工艺验证，2005	2005	PDA	PDA TR	有
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	缺
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	有
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	缺
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	缺
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	缺
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	有
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	有
87	50. Alternative Methods for Mycoplasma Testing 2010 支原体测试替代性方法，2010	2010	PDA	PDA TR	缺
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	有
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	缺
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	缺
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	有
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	缺
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	缺
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	缺
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2，4，6-三溴苯甲醚和2，4，6-三氯苯甲醚污染和气味的检测和移除，2012	2012	PDA	PDA TR	缺
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	缺
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	缺
98	58. Risk Management for Temperature-Controlled Distribution 2012 温度受控销售风险管理，2012	2012	PDA	PDA TR	缺
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	有
100	60. Process Validation: A Lifecycle Approach 2013 工艺验证：生命周期方法，2013	2013	PDA	PDA TR	有
101	61. Steam In Place 2013 就地蒸汽，2013	2013	PDA	PDA TR	有
102	62. Recommended Practices for Manual Aseptic Processes 2013 人工无菌工艺规范建议，2013	2013	PDA	PDA TR	有
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	缺
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	缺
105	65. Technology Transfer 2014 技术转移，2014	2014	PDA	PDA TR	有
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	缺
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	缺
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	缺
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	有
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	有
116	Q1C: Stability Testing for New Dosage Forms新制剂的稳定性试验		ICH	Quality	有
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	有
118	Q1E: Evaluation of Stability Data对稳定性数据的评估处理		ICH	Quality	有
119	Q1F: Stability Data Package for Registration Applications in Climatic Zones III and IV 在气候带III和IV，药物注册申请所提供的稳定性数据		ICH	Quality	有
120	Q2A: Text on Validation of Analytical Procedures分析程序的验证		ICH	Quality	有
121	Q2B: Validation of Analytical Procedures: Methodology分析程序的验证：方法学		ICH	Quality	有
122	Q3A(R): Impurities in New Drug Substances (Revised Guideline)新原料药中的杂质（修订版）		ICH	Quality	有
123	Q3B(R): Impurities in New Drug Products (Revised Guideline)新制剂中的杂质（修订版）		ICH	Quality	有
124	Q3C: Impurities: Guideline for Residual Solvents杂质：残留溶剂指南		ICH	Quality	有
125	Q3C(M): Impurities: Guideline for Residual Solvents (Maintenance)杂质：残留溶剂指南（修改内容）		ICH	Quality	有
126	Q4: Pharmacopoeias药典		ICH	Quality	有
127	Q4A: Pharmacopoeial Harmonisation 药典的协调		ICH	Quality	有
128	Q4B: Regulatory Acceptance of Pharmacopoeial Interchangeability药典互替在法规上的可接受性		ICH	Quality	有
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	有
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	有
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	有
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	有
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	有
134	Q6: Specifications for New Drug Substances and Products新原料药和制剂的质量规格		ICH	Quality	有
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	有
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	有
137	Q7: Good Manufacturing Practices for Pharmaceutical Ingredients活性药物成份的GMP		ICH	Quality	有
138	Q7A: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients活性药物成份的GMP指南		ICH	Quality	有
139	Q8: Pharmaceutical Development药物研发		ICH	Quality	有
140	Q9: Quality Risk Management质量风险管理		ICH	Quality	有
141	Q10: Pharmaceutical Quality System 药物质量体系		ICH	Quality	有
142	Q11 ：Developmentand manufacture of drug substances原料药的开发与制造		ICH	Quality	有
143	Basic Requirements for Medicinal Products 药品的基本需求		EU	Good manufacturing practice (GMP) Guidelines.	有
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.	有
145	Site Master File 工厂主文件		EU	GMP related documents	有
146	Q9 Quality Risk Management Q9 质量风险管理		EU	GMP related documents	有
147	MRA Batch Certificate MRA批证书		EU	GMP related documents	有
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	有
149	1、Manufacture of Sterile Medicinal Products 无菌药品的生产		EU	Annexes	有
150	2、Manufacture of Biological active substances and Medicinal Products for Human Use 人用生物药品的生产		EU	Annexes	有
151	3、Manufacture of Radiopharmaceuticals 放射性药物的生产		EU	Annexes	有
152	4、Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products 非免疫动物药品的生产		EU	Annexes	有
153	5、Manufacture of Immunological Veterinary Medicinal Products 免疫动物药品的生产		EU	Annexes	有
154	6、Manufacture of Medicinal Gases 医用气体的生产		EU	Annexes	有
155	7、Manufacture of Herbal Medicinal Products 草本药品的生产		EU	Annexes	有
156	8、Sampling of Starting and Packaging Materials 原材料和包装材料的取样		EU	Annexes	有
157	9、Manufacture of Liquids, Creams and Ointments 液体、乳剂、膏剂的生产		EU	Annexes	有
158	10、Manufacture 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	有
159	11、Computerised Systems (revision January 2011) 计算机系统		EU	Annexes	有
160	12、Use 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	有
161	13、Manufacture of Investigational Medicinal Products 研究用药品的生产		EU	Annexes	有
162	14、Manufacture 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	有
163	15、Qualification and validation 确认和验证		EU	Annexes	有
164	16、Certification by a Qualified person and Batch Release 资质人员签发证书和批放行		EU	Annexes	有
165	17、Parametric Release 参数放行		EU	Annexes	有
166	19、Reference and Retention Samples 对照品和留样		EU	Annexes	有
167	Guidelines on Good Distribution Practice of Medicinal Products for human Use		EU	GDP	有
168	21CFR210Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General		FDA	21 Code of Federal Regulations	有
169	VALIDATION OF ASEPTIC PROCESSES	2011.01.01	PIC/S	Guidance documents	有	PE 008-4
170	SITE MASTER FILE FOR SOURCE PLASMA ESTABLISHMENTS	2007.09.25	PIC/S	Site Master Files	有	PE 009-11
171	GOOD PRACTICES FOR COMPUTERISED SYSTEMS IN REGULATED GXP ENVIRONMENTS	2007.09.25	PIC/S	Guidance documents	有	PE 010-4
172	GUIDANCE ON PARAMETRIC RELEASE	2007.09.25	PIC/S	Guidance documents	有	PE 011-1
173	QA DISTRIBUTION ACTIVITIES FOR APIs - MAY 2010	2011.03.24	PIC/S	Q&A Documents	有	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	有	PI 005-3
175	ISOLATORS USED FOR ASEPTIC PROCESSING AND STERILITY TESTING	2007.09.25	PIC/S	Guidance documents	有	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	有	PI 007-6
177	PARTICIPATING AUTHORITIES & PARTNERS & (PRE)-APPLICANTS	2015.01.09	PIC/S	Inspectorates	有	PI 008-3
178	AIDE MEMOIRE ON GMP PARTICULARITIES FOR CLINICAL TRIAL PRODUCTS	2007.09.25	PIC/S	Aide-Memoires	有	PI 009-3
179	QA ON TRACEABILITY OF MEDICINAL GASES	2012.12.18	PIC/S	Q&A Documents	有	PI 010-4
180	PIC/S GMP GUIDE	2014.03.01	PIC/S	PIC/S GMP Guide	有	PI 011-3
181	PIC/S Guide to Good Distribution Practice (GDP) for Medicinal Products	2014.06.01	PIC/S	Guidance documents	有	PI 012-3
182	QUALITY SYSTEM REQUIREMENTS FOR PHARMACEUTICAL INSPECTORATES	2007.09.25	PIC/S	Inspectorates	有	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	有	PI 014-3
184	STANDARD OPERATING PROCEDURE PIC/S INSPECTION REPORT FORMAT	2007.09.25	PIC/S	Inspectorates	有	PI 020-3
185	AIDE MEMOIRE ON INSPECTION OF BIOTECH	2007.09.25	PIC/S	Aide-Memoires	有	PI 021-2
186	AIDE MEMOIRE ON INSPECTION OF QUALITY CONTROL LABORATORIES	2007.09.25	PIC/S	Aide-Memoires	有	PI 023-2
187	AIDE-MEMOIRE INSPECTION OF UTILITIES	2007.09.25	PIC/S	Aide-Memoires	有	PI 024-2
188	AIDE-MEMOIRE ON MEDICINAL GASES	2007.09.25	PIC/S	Aide-Memoires	有	PI 025-2
189	AIDE-MEMOIRE ON PACKAGING	2009.01.13	PIC/S	Aide-Memoires	有	PI 028-1
190	AIDE-MEMOIRE ON THE INSPECTION OF APIS	2009.01.13	PIC/S	Aide-Memoires	有	PI 030-1
191	RECOMMENDATION ON STERILITY TESTING	2007.09.25	PIC/S	Guidance documents	有	PI 031-1
192	PIC/S RECOMMENDATION ON RISK-BASED INSPECTION PLANNING	2012.01.01	PIC/S	Guidance documents	有	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	有	PI 038-1
194	PROCEDURE FOR HANDLING RAPID ALERTS AND RECALLS ARISING FROM QUALITY DEFECTS	2011.01.01	PIC/S	Inspectorates	有	PI-037-1
195	TECHNICAL INTERPRETATION OF REVISED ANNEX 1 TO PIC/S GMP GUIDE	2010.01.08	PIC/S	Guidance documents	有	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	有	PS INF 20 2011
197	STANDARD OPERATING PROCEDURE TEAM INSPECTIONS	2009.07.29	PIC/S	Inspectorates	有	PS W 01 2015
198	SITE MASTER FILE FOR PLASMA WAREHOUSES	2007.09.25	PIC/S	PIC/S GMP Guide	有	PS/INF 21/2002 (Rev 18)
199	AIDE MEMOIRE ON ASSESSMENT OF QRM IMPLEMENTATION	2012.03.26	PIC/S	Aide-Memoires	有
200	Bar Code Label Requirements Questions and Answers	2011.08	FDA（CDER）	Compliance	有	PI 019-3
201	COMPRESSED MEDICAL GASES	1989.12.01	FDA（CDER）	Compliance	有	Final
202	Computerized Systems Used in Clinical Investigations	2007.05	FDA（CDER）	Compliance	有	Final
203	Good Laboratory Practice Regulations Questions and Answers	1981.06.01	FDA（CDER）	Compliance	有	Final
204	Marketed Unapproved Drugs	2011.09.19	FDA（CDER）	Compliance	有	Final
205	Nuclear Pharmacy Guideline Criteria for Determining When to Register as a Drug Establishment	1984.05.01	FDA（CDER）	Compliance	有	Final
206	Part 11, Electronic Records; Electronic Signatures — Scope and Application	2003.09.05	FDA（CDER）	Compliance	有	Final
207	Prescription Drug Marketing Act — Donation of Prescription Drug Samples to Free Clinics	2006.03.14	FDA（CDER）	Compliance	有	Final
208	Prescription Drug Marketing Act (PDMA) Requirements	2006	FDA（CDER）	Compliance	有	Final
209	Review of FDA's Implementation of the Drug Export Amendments of 1986	1990.05.01	FDA（CDER）	Compliance	有
210	Street Drug Alternatives	2000.04.03	FDA（CDER）	Compliance	有	Final
211	21CFR211Current Good Manufacturing Practice for Finished Pharmaceuticals		FDA	21 Code of Federal Regulations	有	Final
212	Comparability Protocols -- Protein Drug Products and Biological Products -- Chemistry, Manufacturing, and Controls Information	2003.02.13	FDA	CMC	有	Draft
213	Current Good Manufacturing Practice for Phase 1 Investigational Drugs	2008.07.15	FDA	Compliance	有	Final
214	Current Good Manufacturing Practices for Medical Gases	2003.05.06	FDA	CGMP,Pharmaceutical Quality	有	Final
215	Expiration Dating of Unit-Dose Repackaged Drugs: Compliance Policy Guide	2005.05.31	FDA	CGMP,Pharmaceutical Quality	有
216	Formal Dispute Resolution_ Scientific and Technical Issues Related to Pharmaceutical CGMP	2006.01.12	FDA	Compliance	有	Draft
217	Good Laboratory Practice Regulations -- Questions and Answers	1981.06.01	FDA	Compliance	有	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		有	Final
219	Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality	2013.06.25	FDA	CGMP,Pharmaceutical Quality	有	Final
220	Immunogenicity-Related Considerations for the Approval of Low Molecular Weight Heparin for NDAs and ANDAs	2014.04.09	FDA	Compliance	有	Final
221	Interim Guidance for 3 Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act		FDA	Compliance	有	Final
222	Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production	2006.10.12	FDA	CGMP,Pharmaceutical Quality	有	Final
223	Marketed Unapproved Drugs;Compliance Policy Guide	2011.09.19	FDA	Compliance	有	Final
224	Part 11, Electronic Records, Electronic Signatures - Scope and Application	2003.09.05	FDA	Compliance	有	Final
225	Pharmaceutical Components at Risk for Melamine Contamination	2009.08.07	FDA	CGMP,Pharmaceutical Quality	有	Final
226	Possible Dioxin/PCB Contamination of Drug and Biological Products	1999.08.23	FDA	CGMP,Pharmaceutical Quality	有	Final
227	Preparation of Investigational New Drug Products (Human and Animal)	1992.11.01	FDA	CGMP,Pharmaceutical Quality	有	Final
228	Process Analytical Technology -- A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance	2004.10.04	FDA	CGMP,Pharmaceutical Quality	有	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	有	Final
230	Pyrogen and Endotoxins Testing: Questions and Answers	2012.06.28	FDA	CGMP,Pharmaceutical Quality	有	Final
231	Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations	2006.10.02	FDA	CGMP,Pharmaceutical Quality	有	Draft
232	Sterile Drug Products Produced by Aseptic Processing	2004.10.04	FDA	CGMP,Pharmaceutical Quality	有	Draft
233	Testing of Glycerin for Diethylene Glycol	2007.05.02	FDA	CGMP,Pharmaceutical Quality	有	Draft
234	The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 - Good Manufacturing Practice (CGMP)	2010.01.27	FDA	CGMP,Pharmaceutical Quality	有

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

快活王

不知道是不是最新的版本，冷链运输的管理。

DK1024

集齐以后就可以迎娶白富美、出任CEO、走上人生癫疯了

wys22639

21 Applied Risk Management for Commissioning and Qualification
调试和确认中的风险管理 　 ISPE 怎么分享？

long_five

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

kkxl1986

再增加个PDA TR69   也分享一些给我吧，邮箱kkxl1986@aliyun.com

hoover

赤裸裸的炫耀，拉仇恨。

羡慕嫉妒恨啊！！！！

h4369323

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

套路

炫富……


论坛发金币帖子任意门
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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

h4369323

套路 发表于 2017-11-16 09:27
炫富……

先富带后富，大家都会有的

lgk1978

厉害了，我的蒲友

过河的小马

我怎么 感觉我都没有

zysx01234

主要是不想看，看了也用不到

clq414

英文不好，潇洒路过

毒行狼

求集齐，求分享，万分感谢

xxr041210

顶，厉害了！！！！！！！

jjb2005

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。

wuqi

666，首先是没有，再者就是英文盲

h4369323

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

270681282

我想要的，你都缺，我们没法愉快的玩耍

h4369323

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

h4369323

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。。。。。。。

h4369323

xxr041210 发表于 2017-11-16 10:12
顶，厉害了！！！！！！！

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

jstanganjun

楼主好人，先分享一部分给我学习一下吧，574835048@qq.com