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| | Quality section of the Common Technical Document: 通用技术文档质量部分： Culture media and other additives (details provided in 3.2.S.2.3) The description should include information on, for example, scale, buffers and other reagents (details provided in 3.2.S.2.3), information on the quality and control, information demonstrating that materials (including biologically-sourced materials, e.g., media components, monoclonal antibodies, enzymes) meet standards appropriate for their intended use (including the clearance or control of adventitious agents) should be provided, as appropriate. For biologically-sourced materials, this can include information regarding the source, manufacture, and characterisation. (Details in 3.2.A.2 for both NCE and Biotech) 培养基及其他添加剂（详见3.2.S.2.3） 应对流程图中各个工艺步骤进行描述，包括如，规模、培养基和其他添加剂(详见3.2.S.2.3) ， 物料控制(名称，生产商) 应列出原料药生产所用的物料(如，原材料、起始物料、溶剂、反应试剂和催化剂等)，并说明各物料在工艺中所使用的步骤。应提供这些物料的质量控制信息。如适用， 应提供信息证明这些物料(包括生物源性物料，如，培养基组分、单克隆抗体、酶等) 符合适当的标准，从而满足其拟定的用途(包括外源因子的清除或控制)。对于生物源性物料，该信息可包括来源、生产及特性鉴定。(新化学实体和生物技术产品的详情均参见 3.2.A.2) 参考ICH指导原则—Q6A 和 Q6B 生物技术产品: 来源和生物源性起始物料的控制 应提供生物源性物料的病毒安全性信息总结。(详见 3.2.A.2) 细胞基质的来源、历史和构建 应提供细胞基质来源及表达系统构建信息，包括对细胞系的基因修饰、从起始细胞克隆构建主细胞库的信息，如 Q5B 和 Q5D 所述。 细胞建库系统、特性鉴定和检验 应提供有关细胞库建立、质量控制及细胞系在生产和贮藏过程中的稳定性信息(包括建立主细胞库和工作细胞库的过程)，如 Q5B 和 Q5D 所述。 参考ICH 指导原则—Q5A、Q5B、Q5C 和 Q5D |
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| | Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin. 来源于人源或动物来源的细胞系生物制品病毒安全性评估 It is recommended that manufacturers develop programs for the ongoing assessment of adventitious viruses in production batches. The scope, extent and frequency of virus testing on the unprocessed bulk should be determined by taking several points into consideration including the nature of the cell lines used to produce the desired products, the results and extent of virus tests performed during the qualification of the cell lines, the cultivation method, raw material sources and results of viral clearance studies. 推荐生产商对生产批次的外来病毒进行持续的评估制定计划。对未处理的原液病毒测试的范围，程度和频率应通过一些点确定，考虑到包括用于生产想要的产品的细胞系的属性，病毒测试（包括细胞系的确认过程，培养方法，原材料来源和病毒清除测试的结果）的结果和程度 |
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| | Good manufacturing practice 良好制造规范 No (raw) material should be released or used before the satisfactory completion of evaluation by the quality unit(s)... The quality unit should establish a system to release or reject raw materials, intermediates, packaging and labeling materials. Specifications should be established and documented for raw materials..... Acceptance criteria should be established and documented for in-process controls. The (API) impurity profile should be compared....in order to detect changes to the API resulting from modifications in raw materials.... 在质量部门满意地完成评估之前，不得放行或使用任何（原）材料…… 质量部门应建立一个放行或拒收原材料、中间体、包装和标签材料的制度。 应制定并记录原材料的规范..... 应制定验收标准，并记录在案，以进行过程控制 应比较（API）杂质档案……为了检测原材料修改导致的API变化…… |
| | Quality risk management. 质量风险管理 This guideline provides principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality, including the use of raw materials. To assess the critical attributes of raw materials, solvents, Active Pharmaceutical Ingredient (API) starting materials, APIs, excipients, or packaging materials. 本指南提供了质量风险管理工具的原理和示例，可应用于药品质量的不同方面，包括原材料的使用。 评估原材料、溶剂、活性药物成分（API）起始材料、API、辅料或包装材料的关键属性。 |
| | Development and manufacture of Drug Substance 原料药的开发和制造 The manufacturing process development program should identify which material attributes (e.g., of raw materials, starting materials, reagents, solvents, process aids, intermediates) and process parameters should be controlled. Risk assessment can help identify the material attributes and process parameters with the potential for having an effect on drug substance CQAs. Those material attributes and process parameters that are found to be important to drug substance quality should be addressed by the control strategy. The quality of each raw material used in the manufacturing process should be appropriate for its intended use. Raw materials used in operations near the end of the manufacturing process have a greater potential to introduce impurities into the drug substance than raw materials used upstream. Therefore, manufacturers should evaluate whether the quality of such materials should be more tightly controlled than similar materials used upstream. 制造工艺开发计划应确定应控制哪些材料属性（如原材料、起始材料、试剂、溶剂、工艺助剂、中间体）和工艺参数。风险评估有助于确定可能对原料药CQA产生影响的材料属性和工艺参数。控制策略应解决对原料药质量重要的材料属性和工艺参数。 制造过程中使用的每种原材料的质量应适合其预期用途。与上游使用的原料相比，生产过程接近尾声时使用的原料将杂质引入原料药的可能性更大。因此，制造商应评估此类材料的质量是否应比上游使用的类似材料受到更严格的控制。 |
9 CFR Part 113 sections 50, 52, 53 | | Requirements for ingredients of animal origin used for production of biologics 用于生物制品生产的动物源 性成分要求 113.50 — Ingredients of biological products. 113.50 — 生物制品的原料 113.52 — Requirements for cell lines used for production of biologics. 113.52 —生物制品生产用细胞系要求 113.53 — Requirements for ingredients of animal origin used for production of biologics. 113.53 — 生物制品生产用的动物来源材料要求 |
| | Constituent materials 组成材料 21 CFR 610.15: constituents shall meet generally accepted standards of purity and quality 21 CFR 610.15:组件必须满足纯度和质量的一般接受标准 |
| | General requirements 一般要求 21 CFR 211.80: Components and drug product containers and closures shall at all times be handled and stored in a manner to prevent contamination. 21 CFR 211.80：应始终以防止污染的方式处理和储存成分和药品容器及密封件。 |
21 CFR 211 Subpart E and 21 CFR 211.110 | | Control of Components and Drug Product Containers and Closures 组件和成品的容器和密封件的控制 21 CFR 211 Subpart E: Control of components and drug product containers and closures; components are required to be controlled by a Quality Control to ensure appropriate management. Testing and monitoring of components...components should be tested for identity and for conformity for purity, strength and quality. 21 CFR 211分部分E：组件和成品的容器和密封件的控制；质量控制需控制组件以确保合适的管理。组件的测试和监控…组件应该进行鉴别和纯度，规格和质量的符合性测试 Sampling and testing of in-process materials and drug products 内部材料和成品的取样及测试 21CFR 211.110: In-process materials shall be tested for ID, strength, quality and purity as appropriate, and approved or rejected by the quality control unit... 21 CFR 211.110：中间品材料应进行鉴别，规格和质量，纯度测试，由 控制单元进行批准或拒绝 |
| Human cells, tissues supplies and cellular and tissue-based products: supplies and reagents | Supplies and reagents 供应和试剂 |
| Fetal bovine serum quality attributes and functionality tests | |
| Growth factors and cytokines used in cell therapy manufacturing | |
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| Cellular- and tissue-based products | |
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| Quality Control Procedures for Raw Materials and Excipients Used for Production of Biologics | |
| Raw Materials of Biological Origin for the Production of Cell-Based And Gene Therapy Medicinal Products | |
| amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use as regards advanced therapy medicinal products | |
Eudralex Volume 4, Annex II | Good Manufacturing Practice (GMP) guidelines EU guideline 2015/C95/02 | |
| EMEA/CHMP/410869/2006 Guideline on Human Cell-Based Medicinal Products | |
| EMEA/CHMP/QWP/396951/2006 Guideline on excipients in the dossier for application for marketing authorisation of a medicinal product | |
EU guideline 2015/C 95/02 | EU Guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use | |
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