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1、药包材关联审评审批申报资料要求,主讲人：寇国通 18603286625 石家庄凯瑞德医药科技发展有限公司，CEO,基本信息概要产品,一、目录 1 企业基本信息 2 直接接触药品的包装系统（以下简称包装系统）的基本信息 2.1 包装系统名称、类型 2.2 包装组件 2.3 配方 2.4 基本特性 2.5 境内外批准及使用信息 2.6 国家标准以及境内外药典收载情况 3 生产信息 3.1 生产工艺的开发 3.2 生产工艺和过程控制 3.3 物料控制 3.4 关键步骤和中间体的控制 3.5 工艺验证和评价,基本信息概要质量,4 包装系统的质量控制 4.1 质量标准 4.2 分析方法的验证 4.3 质
2、量标准制定依据 5 批检验报告 6 稳定性 6.1 稳定性总结 6.2 稳定性数据 6.3 包装及选择依据 7 安全性研究,美国对包材的申报要求,官方的要求美国的要求,B. CGMP, CPSC and USP Requirements on Containers and Closures cGMP要求（ 21 CFR Parts 210 and 211 ），中国对包材也有独立的GMP要求，联合申报也会出细则 包材其它的更加详细的要求：比如防儿童开启等. 药典的要求 注射用途产品风险更大一些 美国药典有更加详细的规定： “玻璃容器内表面耐受性评估”,同制剂申报时的要求,C. Informati
3、on That Should Be Submitted in Support of an Original Application for Any Drug Product （制剂同时申报要求） 需要在新药申请中提及 1. 描述 包装系统整体描述，所有的包材基包材成分提供者要提供： Identification by product name, product code (if available), the name and address of the manufacturer, and a physical description of the packaging component (
4、e.g., type, size, shape, and color) Identification of the materials of construction (i.e., plastics, paper, metal, glass, elastomers, coatings, adhesives, and other such materials) should be identified by a specific product designation (code name and/or code number) and the source (name of the manuf
5、acturer).16 Alternate materials of construction should also be indicated. Postconsumer recycled plastic should not be used in the manufacture of a primary packaging component. If used for a secondary or associated component, then the safety and compatibility of the material for its intended use shou
6、ld be addressed appropriately. Description of any operations or preparations that are performed on a packaging component by the applicant (such as washing, coating, sterilization, or depyrogenation)17,同制剂申报时的要求,2. 包材适用性 所有完整的组成成分每一种组分. 检测结果，定性，关键测试：方法、标准、对照品、方法验证. 保护功能，药典（避光、湿、微生物、无菌）及非药典方法（气体穿透，溶剂泄
7、漏、容器完整性测试） 溶出物生物测试、成分剖析合规？. 功能测试 非药典要求测试要充分说明；药典方法和非药典方法参照；方法验证. 组装后包装系统，申报着要提供：真空泄漏，水分穿透，重量减少，或填充. 单独的组建，往往是包材厂提供资料（DMF）.,质控是双方的共同职责需要注意,3. Information About Quality Control 质控是包材和制剂厂共同的责任 The fabricator/manufacturer of a packaging component and the drug product manufacturer who uses this firm shar
8、e the responsibility for ensuring the quality of packaging components. a. Applicants The tests and methods used by the applicant for acceptance of each batch of a packaging component that they receive should be described. If a batch is to be accepted based on a suppliers COA or COC, then the procedu
9、re for supplier validation should be described. The data from the suppliers COA or COC should clearly indicate that the lot meets the applicants acceptance criteria. Acceptance criteria for extractables should also be included, if appropriate. Dimensional and performance criteria should be provided.
10、 Dimensional information is frequently provided via a detailed schematic drawing complete with target dimensions and tolerances and may be provided via the packaging component manufacturers DMF. A separate drawing may not be necessary if the packaging component is part of a larger unit for which a d
11、rawing is provided or if the component is uncomplicated in design (e.g., a cap liner).,提供给制剂厂包材厂责任,b. Manufacturers of Packaging Components Sold to Drug Product Manufacturers Each manufacturer of a packaging component sold to a drug product manufacturer should provide a description of the quality co
12、ntrol measures used to maintain consistency in the physical and chemical characteristics of the component. These generally include release criteria (and test methods, if appropriate) and a description of the manufacturing procedure. If the release of the packaging component is based on statistical p
13、rocess control,18 a complete description of the process (including control criteria) and its validation should be provided. The description of the manufacturing process is generally brief and should include any operations performed on the packaging component after manufacture but prior to shipping (
14、e.g., washing, coating, and/or sterilization). In some cases it may be desirable for the description to be more detailed and to include in-process controls. This information may be provided via a DMF (see section V). c. Manufacturers of Materials of Construction or of Packaging Components Used to Ma
15、ke Other Packaging Components The quality control procedures of the manufacturer of a packaging component may sometimes rely in whole or in part on the quality control procedures of a manufacturer who makes an intermediate packaging component that is used to create the component. If so, each contrib
16、utor to the final packaging system should provide a description of the quality control measures used to maintain consistency in the physical and chemical characteristics of the separate components and of the assembled packaging system that they provide. The manufacturer of each material of construction should be prepared to describe the quality control measures used to maintain consistency in the chemical characteristics of their product. This information may be provided via a DMF (see section V).,
