FDA行业指南委托生产质量协议中英文.pdf
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1、FDA Guidance for Industry: Contract Manufacturing Arrangements for Drugs:Quality A greements Page 1 / 21 FDA 行业指南:药品委托生产安排:质量协议翻译: Julia Contract Manufacturing Arrangements for Drugs: Quality Agreements Guidance for Industry 行业指南:药品委托生产安排:质量协议 U.S. Department of Health and Human Services Food and Dr
2、ug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Center for Veterinary Medicine (CVM) November 2016 Pharmaceutical Quality/Manufacturing Standards (CGMP) FDA Guidance for Industry: Contract Manufacturing Arrangements for Drugs:Quali
3、ty A greements Page 2 / 21 FDA 行业指南:药品委托生产安排:质量协议翻译: Julia Guidance for Industry Additional copies are available from: Office of Communications, Division of Drug InformationCenter for Drug Evaluation and Research Food and Drug Administration 10001 New Hampshire Ave., Hillandale Bldg., 4 th FloorSilv
4、er Spring, MD 20993-0002 Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353 Email: druginfofda.hhs.gov http:/www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm and/or Office of Communication, Outreach and DevelopmentCenter for Biologics Evaluation and Research Food a
5、nd Drug Administration 10903 New Hampshire Ave., Bldg. 71, Room 3128Silver Spring, MD 20993-0002 Phone: 800-835-4709 or 240-402-8010 Email: ocodfda.hhs.gov http:/www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm and/or Policy and Regulations Staff, HFV-
6、6Center for Veterinary MedicineFood and Drug Administration 7519 Standish Place, Rockville, MD 20855 http:/www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation a
7、nd Research (CDER) Center for Biologics Evaluation and Research (CBER) Center for Veterinary Medicine (CVM) November 2016 Pharmaceutical Quality/Manufacturing Standards (CGMP) FDA Guidance for Industry: Contract M anufacturing Arrangements for Drugs: Quality A greements Page 3 / 21 FDA 行业指南:药品委托生产安排
8、:质量协议翻译: Julia TABLE OF CONTENTS 目录 TABLE OF CONTENTS 目录 3 I. INTRODUCTION 前言 . 4 II. DEFININGTHEWHOAND WHAT OFCONTRACT MANUFACTURING 指定委托生产的人和事 6 III. RESPONSIBILITIESOFPARTIES INVOLVED IN CONTRACTMANUFACTURING委托生产所涉及各方的职责7 IV. DOCUMENTINGCGMPACTIVITIESIN QUALITYAGREEMENTS 在质量协议中记录CGMP 活动 10 A.What
9、 Is a Quality Agreement? 什么是质量协议?. 10 B.Elements of a Quality Agreement 质量协议的要素 11 V. ILLUSTRATIVESCENARIOS案例 17 A.Owners and Contract Facilities Are Both Responsible for CGMP 所有者和受托场所是否都对CGMP负 责?18 B. CGMPs Apply to all Contract Facilities, Including Analytical Testing Laboratories 适用于所有合同场所, 包括分析化
10、验室的CGMP . 19 C.Owners and Contract Facilities Perform Change Control Activities 所有者和受托方实施变更控制活动 20 VI. RECOMMENDATIONS 建议 21 FDA Guidance for Industry: Contract M anufacturing Arrangements for Drugs: Quality A greements Page 4 / 21 FDA 行业指南:药品委托生产安排:质量协议翻译: Julia Contract Manufacturing Arrangements
11、for Drugs:Quality Agreements Guidance for Industry 1 行业指南:药品委托生产安排:质量协议 This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative
12、 approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page. 本指南代表FDA 当前对此问题的看法。它并未赋予任何人以任何权力,也不对FDA 和公众具有任 何强制约束。如果你有一个替代的方法满足适用的法律法规要求,你可以使用该方法。如需对替代 方法进行
13、讨论,请联系本指南标题页上的FDA 官方负责人。 I. INTRODUCTION 前言 This guidance describes FDA current thinking on defining, establishing, and documenting manufacturing activities of the parties involved in contract drug manufacturing subject to current good manufacturing practice (CGMP) requirements. In particular, we de
14、scribe how parties involved in contract drug manufacturing can use quality agreements to delineate their manufacturing activities to ensure compliance with CGMP. 本指南讲述了FDA 当前对于受到CGMP 约束的药品委托生产所涉及各方如何定义、设立 和记录生产活动的看法,尤其是药品委托各方如何使用质量协议来描绘其生产活动,以 确保符合CGMP 。 For purposes of this guidance, we use certain
15、 terms with the following specific meanings: 在本指南中,我们使用了特定的术语,其在指南中的含义如下: Current Good Manufacturing Practice (CGMP) refers to requirements in the Federal Food, Drug, and Cosmetic Act (FD 21 CFR parts 210 and 211; and 21 CFR part 600. 7 Section 501 of the FD describe how changes to processes, equipm
16、ent, methods, and specifications will be managed; and permit the owner to audit its contractorfacilities for compliance with CGMP. ICH 行业指南Q7原料药GMP 指南建议所有者对合同场所进行评估,以确保受托方场 所在指定的操作方面符合CGMP 。它还建议所有者与受托方之间有一份书面批准的协议, 在其中详细定义生产职责,包括各方的质量措施。书面协议还应说明对分包的考虑、描述 如何管理工艺、设备、方法和质量标准变更、允许所有者就是否符合CGMP 方面审计其受 托方的
17、场所。 ICH guidance for industry Q9 Quality Risk Management offers a systematic approach to quality risk management as part of an effective quality system. It discusses quality risk management principles such as risk assessment, risk communication, and risk review and provides examples of tools that ca
18、n be used to make effective and efficient risk-based decisions in, for example, auditing and arranging quality agreements with contract manufacturers. ICH 行业指南Q9风险管理提供了质量风险管理的系统方法,它是有效质量体系的一部 分。它讨论了质量风险管理原则,如风险评估、风险沟通和风险审核,并给出了一些工具 的使用实例,这些工具可以用于做出基于风险的有效且高效的决策,如在审计和安排委托 生产质量协议方面。 ICH guidance for i
19、ndustry Q10 Pharmaceutical Quality System states that, as part of a pharmaceutical quality system, the owner is ultimately responsible for ensuring that “processes are in place to assure the control of outsourced activities and quality of purchased materials.” 17 It indicates that these processes sh
20、ould incorporate quality risk management and include the following critical activities: ICH 行业指南Q10药品质量体系声明,作为药物质量体系的一部分,所有者对于确保 “ 有程序确保外包活动的控制和所购物料的质量” 有最终责任。它指出这些程序应整合在质 量风险管理中,并包括以下关键活动: Assessing the suitability and competence of potential contractors before outsourcing operations or selecting m
21、aterial suppliers. This could be accomplished through audits, material evaluations, or other qualification criteria. 在将操作外包或选择物料供应商之前,评估潜在合同方的可持续性和资质。可以通 过审计、物料评估或其它确认标准来实现。 Defining the manufacturing responsibilities and communication processes for quality- related activities of the involved partie
22、s. For outsourced activities, these should be in a written agreement. 界定相关各方质量相关活动的生产职责和沟通流程。对于外包活动,应该在书面协 议上界定。 16 In ICH Q7, the term company is used rather than owner and is used to refer to an API manufacturer. 在 ICH Q7 中,使用的是“公司”而不是“所有者”来指原料药生产商。 17 In ICH Q10, the term company is used rather t
23、han owner. 在 ICH Q10 中,使用的是“公司”而不是“所有者”。 FDA Guidance for Industry: Contract M anufacturing Arrangements for Drugs: Quality A greements Page 10 / 21 FDA 行业指南:药品委托生产安排:质量协议翻译: Julia Monitoring and reviewing the performance of the contract facility and identifying and implementing any needed improveme
24、nts. 监测和审核受托场所的表现,识别并实施所需的改进措施。 Monitoring incoming ingredients and materials to ensure they are from approved sources using the agreed-upon supply chain. 监测进厂成分和物料,以确保他们是来自批准过的来源,并且使用的是经过认可的 供应链。 FDA encourages parties engaged in contract manufacturing to implement quality management practices. Thi
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