洛施德GMP咨询 - FDA行业指南 - 药品生产中OOS结果的调查中文版.pdf
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1、Soltoris Management Consultants, Inc. 洛施德企业管理咨询(上海)有限公司 第 1 页 / 共 22 页 , Soltoris Management Consultants, Inc. Guidance for Industry 行业指南行业指南 Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production 药品生产中药品生产中 OOS 结果的调查结果的调查 Soltoris Management Consultants, Inc. 洛施德企业管理咨询(
2、上海)有限公司 第 2 页 / 共 22 页 , Soltoris Management Consultants, Inc. Content 目录目录 1 INTRODUCTION 介绍介绍 . 3 2 BACKGROUND 背景背景. 4 3 IDENTIFYING AND ASSESSING OOS TEST RESULTS 界定和评价界定和评价 OOS 检验结果检验结果 . 6 A. Responsibility of the Analyst 化验员职责 . 7 B. Responsibilities of the Laboratory Supervisor 化验室主管职责 . 8 4
3、INVESTIGATING OOS TEST RESULTS 对对 OOS 结果的调查结果的调查 . 10 A. Review of Production 生产情况审核 . 10 B. Additional Laboratory Testing 附加化验室测试 . 12 C. Reporting Testing Results 报告测试结果 . 14 5 CONCLUDING THE INVESTIGATION 调查结论调查结论 . 19 A. Interpretation of Investigation Results 调查结果解释 . 19 B. Cautions 注意事项 . 20 C
4、. Field Alert Reports 现场警示报告 . 21 Soltoris Management Consultants, Inc. 洛施德企业管理咨询(上海)有限公司 第 3 页 / 共 22 页 , Soltoris Management Consultants, Inc. GUIDANCE FOR INDUSTRY1 行业指南行业指南 Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production 药物生产中不合格结果的调查 This guidance represents
5、the Food and Drug Administrations (FDAs) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulati
6、ons. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. 本指南代表 FDA 对本专题现行的想法。它没有给任何人创造或者赋予他们任何的权利,而且也不会束缚FDA 或公众的操作。如
7、果有替代的方法能满足法律法规的要求,你可以使用一个替代的方法。如果你要讨论一个替代的方法,请联系负责实施本指南的 FDA 工作人员。如果你不能够识别适当的 FDA 工作人员,请拨打本指南封面页上的适当电话。 1 INTRODUCTION 介绍介绍 This guidance for industry provides the Agencys current thinking on how to evaluate out-of-specification (OOS) test results. For purposes of this document, the term OOS results
8、 includes all test results that fall outside the specifications or acceptance criteria established in drug applications, drug master files (DMFs), official compendia, or by the manufacturer. The term also applies to all in-process laboratory tests that are outside of established specifications.2 本指南
9、旨在表达当局对如何评价 OOS 结果的最新想法。本文件中 OOS 结果这个术语包括所有不符合质量标准,或经由药品申请、DMF 文件、官方药典及生产商所确立的可接受标准的检测结果。这个术语也适用于所有不符合已建立标准的中控化验室检测结果。 This guidance applies to chemistry-based laboratory testing of drugs regulated by CDER. It is directed toward traditional drug testing and release methods. These laboratory tests ar
10、e performed on active pharmaceutical ingredients, excipients and other components, in-process materials, and finished drug products3 to the extent that current good manufacturing practice (CGMP) regulations (21 CFR parts 210 and 211) and the Federal Food, Drug, and Cosmetic Act (the Act) (section 50
11、1(a)(2)(B) apply. The principles in this guidance also apply to in-house testing of drug product components that are purchased by a firm. This guidance can also be used by contract firms performing production and/or laboratory testing responsibilities. Specifically, the guidance discusses how to inv
12、estigate OOS test results, including the responsibilities of laboratory personnel, the laboratory phase of the investigation, additional testing that may be necessary, when to expand the investigation outside the laboratory, and the final evaluation of all test results. 本指南适用于由 CDER 管理的药品类别的化学实验室。它直
13、接针对传统的药品测试和放行方法。这些实验室检测项目是对活性药物成份、赋形剂和其它组件、中控材料和制剂成品,这些就是 CGMP 法规Soltoris Management Consultants, Inc. 洛施德企业管理咨询(上海)有限公司 第 4 页 / 共 22 页 , Soltoris Management Consultants, Inc. (21CFR210 部分和 211 部分)和联邦食品药品和化妆品法案(501(a)(2)(B))所适用的范围。本指南的公司采购的用于制剂成品的组件在公司内的检测。本指南也能用于承担生产和/或实验室测试的合同公司,尤其是, 指南讨论如何调查 OOS
14、结果时, 包括实验室人员职责, 化验室调查阶段、 可能需要的附加测试、何时扩大调查至化验室之外,和所有检测结果的最终评价。 The Agency, in accordance with its August 2002 “Pharmaceutical CGMPs for the 21st Century” initiative, encourages modern approaches to manufacturing, monitoring, and control to enhance process predictability and efficiency. Process Analyt
15、ical Technology (PAT) takes a different approach to quality assurance by using process controls and in-process data as the release specification instead of relying on single laboratory determinations to make batch acceptability decisions. This guidance is not intended to address PAT approaches, as r
16、outine in-process use of these methods might include other considerations. For information on timely in-process testing, see the CGMP guidance entitled PAT A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance. 官方机构,按照 2002 年 8 月“21 世纪药品 CGMPS”倡导的,鼓励采用现代方法制造、监测和
17、控制以提高工艺可预测性和效率。工艺分析技术(PAT)采用了不同的质量保证方法,即采用工艺控制和制程数据作为放行标准而不仅信赖于单一的化验室检测来作出批放行决定。由于这些方法的用于常规制程可能还有其它考虑,本指南并准备对 PAT 方法进行探讨。关于即时制程检测,参见 CGMP 指南 PAT-药品研发、生产和质量保证框架。 FDAs guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Ag
18、encys current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. FDA 的指南文件, 包括本指南, 并不具备法规强制性。 指南仅是用于表述当局的目
19、前对某个问题的看法,应该当作一种推荐来采纳,除非在其中引用了特定的法规要求。在官方指南中,SHOULD 表示建议或推荐的方法,并非必须。 2 BACKGROUND 背景背景 Laboratory testing, which is required by the CGMP regulations ( 211.160 and 211.165), is necessary to confirm that components, containers and closures, in-process materials, and finished products conform to specif
20、ications, including stability specifications. cGMP 法规(211 章第 160 部分和 211 章第 165 部分)要求化验室对药品的成分、包装材料、过程控制及成品进行检测,确保其达到既定的标准要求,包括稳定性标准要求。 Testing also supports analytical and process validation efforts.4 General CGMP regulations covering laboratory operations can be found in part 211, subparts I (Labo
21、ratory Controls) and J (Records and Reports). These regulations provide for the establishment of scientifically sound and appropriate specifications, standards, and test procedures that are designed to ensure that components, containers and closures, in-process materials, and finished drug products
22、conform to the established standards. Section 211.165(f) of the CGMP regulations specifies that finished drug products that fail to meet established standards, specifications, or other relevant quality control criteria will be rejected. Soltoris Management Consultants, Inc. 洛施德企业管理咨询(上海)有限公司 第 5 页 /
23、 共 22 页 , Soltoris Management Consultants, Inc. 检验亦应支持方法验证和工艺验证。通用 CGMP 规范包括化验室操作,在 211 部分章节 I (化验室控制) 和 J (记录和报告)可以查阅到。这些法规用于建立科学合理和适当的质量规格、标准和检验方法,用于保证组件、容器和密闭器材、中控材料和制剂成品符合既定标准。CGMP 法规 211 部分 165(f)指出制剂成品不符合既定标准、规格或其它相应质量控制标准时应拒绝放行。 Both finished pharmaceuticals and active pharmaceutical ingredie
24、nts (APIs) are to be manufactured in accordance with current good manufacturing practice under section. 制剂成品和原料药(APIs)生产均应符合现行 GMP 对应条款下的要求。 501(a)(2)(B) of the Act. Current good manufacturing practice for APIs includes the performance of scientifically sound raw material testing, in-process monitor
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