| 类别 | ISPE指南名称 | Date |
| GAMP | GAMP Guide: Records & Data Integrity / 记录和数据完整性 | 2017 |
| GAMP GPG | A Risk-Based Approach to Calibration Management (2nd Ed) / 校验管理 | 2010 |
| GAMP GPG | Validation and Compliance of Computerized GCP Systems & Data / 计算机化GCP系统的验证和合规性 | 2017 |
| GAMP GPG | Electronic Data Archiving / 电子数据归档 | 2007 |
| GAMP GPG | Global Information Systems Control & Compliance (2nd Ed) / 全球信息系统控制和合规性 | 2017 |
| GAMP GPG | A Risk-Based Approach to GxP Process Control Systems (2nd Ed) / GXP工艺控制系统 | 2011 |
| GAMP GPG | IT Infrastructure Control and Compliance (2nd Ed) / IT基础架构控制和合规性 | 2017 |
| GAMP GPG | Manufacturing Execution Systems - A Strategic and Program Management Approach / 制造执行系统-策略和程序管理方法 | 2010 |
| GAMP GPG | A Risk-Based Approach to Operation of GxP Computerized Systems / GXP计算机化系统操作 | 2010 |
| GAMP GPG | A Risk-Based Approach to Regulated Mobile Applications / 受监管的移动应用 | 2014 |
| GAMP GPG | A Risk-Based Approach to Testing of GxP Systems (2nd Ed) / 测试GXP系统 | 2012 |
| GPG | Assessing the Particulate Containment Performance of Pharmaceutical Equipment (2nd Ed) / 评估制药设备颗粒密闭性能 | 2012 |
| GPG | Booklet Labels / (临床用)书册标签 | 2013 |
| GPG | Clinical Supply Systems / 临床供应系统 | 2014 |
| GPG | Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems (2nd Ed) / 制药用水和蒸汽系统的调试和确认 | 2014 |
| GPG | Comparator Management / (临床)对照药品管理 | 2012 |
| GPG | Controlled Temperature Chamber Mapping & Monitoring / 控温室(温度)分布和监测 | 2016 |
| GPG | Decommissioning Pharmaceutical Equipment & Facilities / 退役(报废)制药设备和设施 | 2017 |
| GPG | Development of Investigational Therapeutic Biological Products / 研究性治疗用生物产品的开发 | 2007 |
| GPG | Interactive Response Technology / 交互式响应技术 | 2011 |
| GPG | Maintenance / 维护 | 2009 |
| GPG | Management of Engineering Standards / 工程标准管理 | 2016 |
| GPG | Operations Management / 运营管理 | 2016 |
| GPG | Ozone Sanitization of Pharmaceutical Water Systems / 制药水系统的臭氧消毒 | 2012 |
| GPG | Packaging, Labeling, and Warehousing Facilities / 包装、标签和仓储设施 | 2012 |
| GPG | Sampling for Pharmaceutical Water, Steam, and Process Gases / 制药用水、蒸汽和工艺气体的取样 | 2016 |
| GPG | Harmonizing the Definition and Use of Non-Investigational Medicinal Products (NIMPs) / 协调非研究性药品的定义和使用 | 2013 |
| BG | Vol 2: Oral Solid Dosage Forms (3rd Ed) / 口服固体制剂 | 2016 |
| BG | Vol 3: Sterile Product Manufacturing Facilities (3rd Ed) / 无菌药品生产设施 | 2018 |
| BG | Vol 6: Biopharmaceutical Manufacturing Facilities (2nd Ed) / 生物制药生产设施 | 2013 |
| BG | Vol 7: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP)(2nd Ed) / 基于风险的药品制造 | 2017 |
| PQLI Guide | Part 1: Product Realization using QbD: Concepts and Principles / 使用QbD的产品实现：概念和原则 | 2011 |
| PQLI Guide | Part 2: Product Realization using QbD: Illustrative Example / 使用QbD的产品实现：说明性范例 | 2011 |
| PQLI Guide | Part 3: Change Management System as a Key Element of a Pharmaceutical Quality System / 制药质量系统关键要素-变更管理 | 2012 |
| PQLI Guide | Part 4: Process Performance and Product Quality Monitoring System / 工艺性能和药品质量监测体系 | 2013 |
| Guide | Biopharmaceutical Process Development and Manufacturing / 生物制药工艺开发和制造 | 2013 |
| No. | PDA技术报告名称 | Date |
| 10 | Parenteral Formulations of Proteins and Peptides: Stability and Stabilizers (Retired) / 蛋白质和多肽的注射剂配方：稳定性和稳定剂 | 1988 |
| 18 | Validation of Computer-Related Systems (Retired) / 计算机相关系统验证 | 1995 |
| 20 | Report on Survey of Current Industry Gowning Practices (Retired) / 当前行业着装习惯调查报告 | 1990 |
| 23 | Industry Survey on Current Sterile Filtration Practices (Retired) / 当前无菌过滤习惯行业调查 | 1997 |
| 30 | Parametric Release of Pharmaceuticals and Medical Device Products Terminally Sterilized by Moist Heat (Revised) / 最终湿热灭菌药品和医疗器械的参数放行（修订） | 2012 (1999) |
| 43 | Identification and Classification of Nonconformities in Molded and Tubular Glass Containers for Pharmaceutical Manufacturing (Revised) / 药品生产用模制和管制玻璃容器缺陷的识别和分类 | 2013 (2007) |
| 45 | Filtration of Liquids Using Cellulose-Based Depth Filters / 使用纤维素基深层过滤器的液体过滤 | 2008 |
| 46 | Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to the End User / 最后一英里：给最终用户药品的GDP指南 | 2009 |
| 47 | Preparation of Virus Spikes Used for Virus Clearance Studies / 用于病毒清除研究的病毒加标样的制备 | 2010 |
| 50 | Alternative Methods for Mycoplasma Testing / 支原体检测的替代方法 | 2010 |
| 52 | Guidance for Good Distribution Practices (GDPs) for the Pharmaceutical Supply Chain / 制药供应链的良好分销规范指南 | 2011 |
| 53 | Guidance for Industry: Stability Testing to Support Distribution of New Drug Products / 工业指南：支持新药分销的稳定性测试 | 2011 |
| 54-2 | Annex 1: Case Study Examples for Quality Risk Management in Packaging and Labeling / 附件1：包装和标签中QRM案例研究示例 | 2013 |
| 54-3 | Annex 2: Case Studies in the Manufacturing of Pharmaceutical Drug Products / 附件2：药品制造中的案例研究 | 2013 |
| 54-4 | Annex 3: Case Studies in the Manufacturing of Biotechnological Bulk Drug Substances / 附件3：生物技术散装原料药制造中的案例研究 | 2014 |
| 54-5 | Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems / 制造系统的设计、确认和操作的QRM | 2017 |
| 55 | Detection and Mitigation of 2,4,6-Tribromoanisole and 2,4,6-Trichloroanisole Taints and Odors in the Pharmaceutical and Consumer Healthcare Industries / 制药和消费者保健行业中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缓解 | 2012 |
| 56 | Application of Phase-Appropriate Quality Systems and CGMP to the Development of Therapeutic Protein Drug Substance / 与阶段相适当的质量体系和CGMP在治疗性蛋白质药物研发中的应用 | 2016 (2012) |
| 57-2 | Analytical Method Development and Qualification for Biotechnology Products / 生物技术产品的分析方法开发和确认 | 2015 |
| 58 | Risk Management for Temperature-Controlled Distribution / 温控分销的风险管理 | 2012 |
| 60-2 | Annex 1: Oral Solid Dosage/Semisolid Dosage Forms / 附件1：口服固体/半固体制剂 | 2017 |
| 63 | Quality Requirements for the Extemporaneous Preparation of Clinical Trial / 临床试验临时制剂的质量要求 | 2013 |
| 67 | Exclusion of Objectionable Microorganisms from Nonsterile Pharmaceuticals, Medical Devices, and Cosmetics / 从非无菌药品、医疗器械和化妆品中排除有害微生物 | 2014 |
| 71 | Emerging Methods for Virus Detection / 新出现的病毒检测方法 | 2015 |
| 72 | Passive Thermal Protection Systems for Global Distribution: Qualification and Operational Guidance / 用于全球分销的被动式温度保护系统：确认和操作指南 | 2015 |
| 73 | Prefilled Syringe User Requirements for Biotechnology Applications / 用于生物技术应用的预灌装注射器用户要求 | 2015 |
| 74 | Reprocessing of Biopharmaceuticals / 生物药品的返工 | 2016 |
| 75 | Consensus Method for Rating 0.1μm Mycoplasma Reduction Filters / 0.1μm支原体降低过滤器的共识分级方法 | 2016 |
| 76 | Identification and Classification of Visible Nonconformities in Elastomeric Components and Aluminum Seals for Parenteral Packaging / 针剂包装用人造橡胶组件和铝盖的可见缺陷的识别和分类 | 2016 |
| 77 | The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology / 使用吹灌封技术的无菌药品制造 | 2017 |
| 78 | Particulate Matter in Oral Dosage Forms / 口服制剂中的微粒物质 | 2017 |
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