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88 篇 CMC 和 GMP 指南上线，IPEM 和识林助力药业国际化
6月20日，识林邀请美国FDA和IPEM教育项目与70多位参会者共议知识型产业、学习型企业和求知型人才的药业未来。会上美国FDA驻华办Lane Christensen博士代表FDA主管国际合作的副局长Mary Lou Valdez女士，向IPEM师生表示感谢，并向IPEM项目负责人郑强教授转交了赞誉信。
2007年美国FDA和北京大学合办了IPEM项目，并在FDA向美国国会的报告中数次作为亮点。除了通过教育，应用型研究也是美国FDA促进中国制药业国际化的方式。IPEM已和美国FDA多次合作植物药批准卷宗、批准前检查、生物等效性案例等翻译，这些翻译之所以称之为研究，因其系统化规范了术语，深入了解了政策制定的背景和思考，尽管还存在不少时间和能力造成的不足，但为业界准确把握和系统学习美国FDA的法规和监管要求提供了起点。
这封赞誉信源于2017年8月起，40余位IPEM成员（见表1）历时近8个月，完成了88篇CMC和GMP的关键行业指南和检查指南的翻译，并通过识林发布，只要在识林App上免费注册就可以学习和应用大多数指南（详见表2）。8个月中，3个月用于指南初稿的翻译，而校对和标准化历时5个月，强调的并非个别指南的文字优美或贴近汉语习惯，而是用词的系统化和一致性，翻译的准确性和完整性。
| 序号
| 标题
| 版本
|
| 1
| 21 CFR 210 & 211
| N/A
|
| 2
| Part 11 电子记录；电子签名
| N/A
|
| 3
| Analytical Procedures and Methods Validation for Drugs and Biologics
药品和生物制品分析流程和方法验证
| 07/24/2015
|
| 4
| Analytical Procedures and Methods Validation
分析流程和方法验证
| 08/2000
|
| 5
| ANDAs: Impurities in Drug Products
ANDAs: 制剂中的杂质
| 11/26/2010
|
| 6
| ANDAs: Impurities in Drug Substances
ANDAs: 原料药中的杂质
| 07/15/2009
|
| 7
| ANDAs: Stability Testing of Drug Substances and Products
ANDAs：原料药和制剂的稳定性研究
| 06/18/2013
|
| 8
| ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers
ANDAs：原料药和制剂稳定性试验 问题与解答
| 05/14/2014
|
| 9
| ANDAs: Pharmaceutical Solid Polymorphism: Chemistry, Manufacturing, and Controls Information
ANDAs：药物固态多晶型 化学，生产，和控制信息
| 07/06/2007
|
| 10
| Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products
指定生物技术和指定合成生物制品已批准申请的变更
| 07/01/1997
|
| 11
| Changes to an Approved NDA or ANDA
已获批 NDA 或 ANDA 的变更
| 04/01/2004
|
| 12
| Changes to an Approved NDA or ANDA: Questions and Answers
已获批NDA和ANDA的变更问题与解答
| 01/01/2001
|
| 13
| Changes to an Approved NDA or ANDA; Specifications – Use of Enforcement Discretion for Compendial Changes
已获批NDA或ANDA的变更；质量标准－药典变更执法自由裁量权的使用
| 11/19/2004
|
| 14
| CMC Post approval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports
年报记录的指定生物制品的CMC批准后生产变更
| 08/2017
|
| 15
| CMC Post approval Manufacturing Changes To Be Documented in Annual Reports
年报文件记录CMC批准后生产变更
| 03/04/2014
|
| 16
| Container Closure Systems for Packaging Human Drugs and Biologics -- Questions and Answers
人用药品及生物制品包装用容器密闭系统问答
| 05/01/2002
|
| 17
| Container Closure Systems for Packaging Human Drugs and Biologics
人用药品和生物制品包装用容器密闭系统
| 05/01/1999
|
| 18
| Dissolution Testing and Specification Criteria for Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutics Classification System Class 1 and 3 Drugs
含有BCS 1类和3类药物口服固体速释剂型的溶出度测试和标准限度
| 07/31/2015
|
| 19
| Elemental Impurities in Drug Products
成品中的元素杂质
| 06/30/2016
|
| 20
| Environmental Assessment of Human Drug and Biologics Applications
人用药品和生物制品申请的环境评价
| 07/01/1998
|
| 21
| Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products
设定条件:已批准的药品和生物制品的可报告的化学、生产、控制 (CMC) 变更
| 05/29/2015
|
| 22
| Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron
含铁口服固体制剂的有效期和稳定性试验
| 06/27/1997
|
| 23
| Format and Content for the CMC Section of an Annual Report
年度报告CMC部分的格式和内容
| 09/01/1994
|
| 24
| Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products
无菌产品稳定性方案中使用容器密闭系统完整性检验代替无菌检查
| 02/01/2008
|
| 25
| NDAs: Impurities in Drug Substances
NDAs: 原料杂质研究
| 02/01/2000
|
| 26
| PAC-ATLS: Post approval Changes - Analytical Testing Laboratory Sites
PAC-ATLS: 批准后变更 — 分析实验室地点变更
| 04/28/1998
|
| 27
| Residual Solvents in Drug Products Marketed in the United States
美国上市制剂中的残留溶剂
| 11/24/2009
|
| 28
| Reviewer Guidance, Validation of Chromatographic Methods
CDER 审评员指南 色谱方法验证
| 11/01/1994
|
| 29
| Statistical Approaches to Evaluate Analytical Similarity Draft
评价分析相似性的统计方法
| 09/21/2017
|
| 30
| SUPAC-IR Questions and Answers about SUPAC-IR Guidance
SUPAC-IR: 普通制剂扩大规模或上市后变更指导原则有关事项的问题和解答
| 02/18/1997
|
| 31
| SUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Post approval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation
SUPAC-MR：固体口服缓控释制剂放大生产和批准后变更：体外释放度和体内生物等效性的要求
| 09/1997
|
| 32
| SUPAC-SS: Nonsterile Semisolid Dosage Forms Scale-Up and Post approval Changes: Chemistry, Manufacturing, and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation
SUPAC-SS: 非无菌半固体制剂扩大规模和上市后变更：体外释放试验和体内生物等效性要求
| 05/1997
|
| 33
| Contract Manufacturing Arrangements for Drugs: Quality Agreements
药品合同外包生产安排：质量协议
| 11/22/2016
|
| 34
| Contract Manufacturing Arrangements for Drugs: Quality Agreements
药品合同外包生产安排：质量协议
| 05/24/2013
|
| 35
| Current Good Manufacturing Practice for Phase 1 Investigational Drugs
1期研究用药品的现行生产质量管理规范
| 07/14/2008
|
| 36
| Current Good Manufacturing Practice Requirements for Combination Products
组合产品的CGMP要求
| 01/10/2017
|
| 37
| Data Integrity and Compliance With Current Good Manufacturing Practice
数据可靠性和CGMP合规指南
| 04/14/2016
|
| 38
| Expiration Dating of Unit-Dose Repackaged Drugs: Compliance Policy Guide
单位剂量分包装药物的效期设定：合规政策指南
| 05/31/2005
|
| 39
| Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products
固体口服制剂单剂量重新包装产品有效期设定
| 08/2017
|
| 40
| Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP_PRA
正式争议解决：关于药物CGMP的科学和技术问题
| 01/11/2006
|
| 41
| Computerized Systems Used in Clinical Investigations
用于临床研究的计算机化系统
| 05/10/2007
|
| 42
| Pyrogen and Endotoxins Testing: Questions and Answers
热原和内毒素测试：问题与解答
| 06/28/2012
|
| 43
| Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality
药用和医疗器械用肝素：监控粗品肝素质量指南定稿
| 06/25/2013
|
| 44
| Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality
药用和医疗器械用肝素：监控粗品肝素质量指南草案
| 02/10/2012
|
| 45
| Investigating Out-of-Specification Test Results for Pharmaceutical Production
药品生产中 OOS 检测结果的调查
| 10/11/2006
|
| 46
| Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography
用于验证PET（正电子发射断层扫描）药物无菌工艺的培养基灌装指南
| 04/10/2012
|
| 47
| Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination
非青霉素β-内酰胺类药物：用于预防交叉污染的cGMP框架
| 04/17/2013
|
| 48
| Part 11, Electronic Records; Electronic Signatures — Scope and Application
Part 11, 电子记录；电子签名—范围和应用
| 08/01/2003
|
| 49
| PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance
过程分析技术(PAT)-用于规范创新药研发，生产及质量保证的框架
| 09/29/2004
|
| 50
| PET Drug Products - Current Good Manufacturing Practice (CGMP)
正电子发射断层扫描药物（PET）—— 现行药品生产质量管理规范 (CGMP)
| 12/09/2009
|
| 51
| PET Drugs--Current Good Manufacturing Practice (CGMP); Small Entity Compliance Guide
PET 药品 - CGMP（小型实体合规指南）
| 08/04/2011
|
| 52
| Pharmaceutical Components at Risk for Melamine Contamination
有三聚氰胺污染风险的药用成分
| 08/06/2009
|
| 53
| Possible Dioxin/PCB Contamination of Drug and Biological Products
药品和生物制品可能的二噁英/多氯联苯污染
| 08/23/1999
|
| 54
| Powder Blends and Finished Dosage Units — Stratified In-Process Dosage Unit Sampling and Assessment
混粉和最终剂量单位—分层的过程中剂量单位取样和评估
| 08/2003
|
| 55
| Preparation of Investigational New Drug Products (Human and Animal)
临床研究新药的制备指南（人用药和动物药）
| 11/01/1992
|
| 56
| Process Validation: General Principles and Practices
工艺验证 一般原则与规范
| 01/24/2011
|
| 57
| Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations
制药企业CGMP规范的质量体系方法
| 09/27/2006
|
| 58
| Questions and Answers on Current Good Manufacturing Practices for Drugs
药品CGMP问答
| N/A
|
| 59
| Request for Quality Metrics
质量量度要求
| 07/27/2015
|
| 60
| Quality Metrics Technical Conformance Guide, Version 1.0
质量量度技术标准指导
| 06/24/2016
|
| 61
| Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice
无菌工艺生产的无菌制剂生产质量管理规范
| 09/29/2004
|
| 62
| Submission of Quality Metrics Data
提交质量量度数据
| 11/23/2016
|
| 63
| Testing of Glycerin for Diethylene Glycol
甘油中二甘醇检测的技术要求
| 05/01/2007
|
| 64
| The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 – Current Good Manufacturing Practice (CGMP)
溶出仪1和2的机械校验的使用现行生产质量管理规范（CGMP）
| 01/26/2010
|
| 65
| Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11
21 CFR Part 11背景下电子记录和电子签名在临床研究中的应用问与答
| 06/20/2017
|
| 66
| Good Abbreviated New Drug Application Assessment Practices
ANDA评估质量管理规范
| 01/03/2018
|
| 67
| Active Pharmaceutical Ingredients
原料药检查
| 09/11/2016
|
| 68
| Addendum - Imported Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps)
附录-进口的人体细胞、组织以及基于细胞和组织的产品
| 01/01/2015
|
| 69
| Drug Manufacturing Inspections
药品生产检查
| 09/11/2016
|
| 70
| Drug Manufacturing Inspections
药品生产检查
| 10/31/2020
|
| 71
| Drug Quality Reporting System (DQRS) (MedWatch Reports) NDA Field Alert Reporting (FARs)
药品质量报告系统（Drug Quality Reporting System，DQRS）（MedWatch报告）；NDA现场警戒报告（Field Alert Reports，FAR）
| 09/11/2016
|
| 72
| Drug Quality Sampling and Testing - Human Drugs
药品质量抽样和检测（Drug Quality Sampling and Testing，DQST）-人用药品
| 09/11/2016
|
| 73
| Drug Repackers and Relabelers
药物再包装商和再贴签商
| 09/11/2016
|
| 74
| Enforcement of the Post marketing Adverse Drug Experience (PADE) Reporting Inspections
上市后药物不良体验（Post marketing Adverse Drug Experience，PADE）报告检查
| 12/15/2015
|
| 75
| Imported CBER-Regulated Products
CBER监管进口产品
| 01/01/2012
|
| 76
| Inspection of Biological Drug Products
生物药品检查
| 10/01/2010
|
| 77
| Inspection of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)(Covers HCT/Ps recovered after 5/25/2005)
人体细胞、组织或基于细胞、组织的产品的检查（HCT/Ps）
| N/A
|
| 78
| Inspection of Licensed and Unlicensed Blood Banks, Brokers, Reference Laboratories, and Contractors
对已许可和未许可血库、代理商、参照实验室和合同商的检查
| 06/01/2016
|
| 79
| Inspection of Licensed In-Vitro Diagnostic (IVD) Devices Regulated by CBER
检查由生物制品审评与研究中心监管许可的体外诊断（In-Vitro Diagnostic，IVD）器械
| 10/01/2012
|
| 80
| Inspection of Source Plasma Establishments, Brokers, Testing Laboratories, and Contractors
原料血浆采集机构、代理商、检测实验室和合同商的检查
| 06/01/2016
|
| 81
| Inspection of Tissue Establishments (Covers human tissue recovered before 5/25/2005)
组织企业的检查（包含5/25/2005前收回的人体组织）
| N/A
|
| 82
| Inspections of Licensed Biological Therapeutic Drug Products
许可生物治疗药品的检查
| 09/11/2016
|
| 83
| Positron Emission Tomography
正电子发射断层扫描(Positron Emission Tomography, PET) CGMP药品流程和批准前检查/调查
| 09/11/2016
|
| 84
| Post-Approval Audit Inspections
批准后稽查检查
| N/A
|
| 85
| Pre-Approval Inspections-Investigations
批准前检查
| 05/11/2012
|
| 86
| Radioactive Drugs
放射性药物
| 09/11/2016
|
| 87
| Sterile Drug Process Inspections
无菌药品生产检查
| 09/11/2016
|
| 88
| Unapproved New Drugs (Marketed, Human, Prescription Drugs only)
未获批新药（仅限于上市销售，人用，处方药）
| 10/19/2009
|
