发布时间 : 星期日 文章New GMP ANVISA Regulation - RDC16 2013 - English Version(1)-对照译文更新完毕开始阅读
4.1.1.一般说明每个厂商应建立并维护产品设计控制程序，确保满足项目的规定要求。
4.1.1. General Instructions Each manufacturer shall establish and maintain procedures to control product design to ensure that the specified requirements for the project are met.
4.1.2.项目规划与开发每个厂商应建立并维护项目计划，计划的内容包括项目和开发活动描述和说明，以及每个活动的负责人。项目计划应说明或参照项目开发活动，包括与开发活动有接触的不同组织群组和技术群组之间的互动。项目计划应根据项目开发进度进行评估、更新、审批。
4.1.2. Project planning and development. Each manufacturer shall establish and maintain plans that describe or indicate project and development activities, and the people responsible for each activity. The plans should describe or refer to the activities of project development, including any interaction between the various organizational and technical groups that may have some interface with it. The plans should be evaluated, updated and approved as project development progresses.
4.1.3.项目/设计输入每个厂商应建立并维护相关程序，确保产品相关要求适用于且满足预期用于，包括用户和患者的需求以及法律法规的要求。上述程序应包含对不完整、模棱两可或相互矛盾的要求进行确定和处理的机制。项目的输入数据应由指定的有资格人士进行记录、评估和审批。要求审批的内容，包括日期和/或负责人签名电子版必须记录在案。
4.1.3. Project/Design Input. Each manufacturer shall establish and maintain procedures to ensure that the requirements relating to a product are appropriate and meet its intended use, including the needs of the user and patient and legal requirements and regulations. The procedures shall include a mechanism that allows incomplete requirements, ambiguous or conflicting are identified and treated. The input data of a project should be documented, evaluated and approved by a qualified person designated. The approval requirements, including the date and or electronic signature of the approver should be documented.
4.1.4.设计验证每个厂商应建立并维护产品设计验证的程序。设计验证应由指定人员开展，确保相关数据满足项目对于输入数据的输出。设计验证的结果，包括经
检查设计的鉴定、验证方法、验证日期、验证负责人姓名应记录在项目历史记录中。 Part c (e)设计评审 设计评审的结果应该记录在设计历史记录中
4.1.4. Design verification. Each manufacturer shall establish and maintain procedures for verification of product design. The design verification should be performed by a designated and shall ensure that the data meet the project's output to the input data. The results of the design verification, including identification of checked design, verification methods, date and name of the person responsible for the verification, shall be documented in the historical record of the project.
4.1.5.项目/设计输出每个厂商应定义并记录项目的数据输出，以评估输出数据是否满足设计要求中输入数据的要求。项目输出数据应满足输入数据的要求，且其中应包含验收标准，并确定对产品预期用途的关键的设计特征。在输出数据发布之前，应对以上各项进行记录、审查和批准。
4.1.5. Project/Design Output. Each manufacturer shall define and document the data output of the project in order to allow assessment of conformity to design requirements as input data. The output data of the project shall meet the requirements of the input data and should include acceptance criteria and identify design features that are essential to the intended use of the product. These should be documented, reviewed and approved prior to release.
4.1.6.项目/设计审查每个厂商应建立并维护相关程序，确保项目结果的评估在项目开发的不同阶段得到适当的规划、开展和记录。而且相关程序还应确保与待审查项目阶段直接关联的所有职能代表以及相关领域的个人和专家都要参与在内。设计审查的结果应记录在项目历史记录中。
4.1.6. Project/Design Review. Each manufacturer shall establish and maintain procedures to ensure that the evaluations of the results of projects are planned, conducted and documented in the various stages of project development. The procedures shall ensure that representatives of all functions directly related to stage of the project that is being reviewed, as well as individuals and experts in related fields required are involved. The results of design review should be documented in the historical record of the project.
4.1.7.项目转化每个厂商应建立并维护项目转化相关程序，确保产品设计正确地转化为生产规范。
4.1.7. Transfer project. Each manufacturer shall establish and maintain procedures to ensure that the product design is correctly translated into production specifications.
4.1.8.设计确认每个厂商应建立并维护产品设计确认的程序。项目的确认应在首批生产批次或设备单元完成后，在预定的操作条件下开展。设计确认必须确保产品满足用户需求和使用指示，并且确认过程应包括对产品在实际或模拟使用条件下进行测试。设计确认必须
在适当情况下使用确认软件。设计确认的结果，包括经检查设计的鉴定、确认方法、确认日期、确认负责人的书面签名和电子版签名应记录在项目历史记录中。适用情况下应进行产品稳定性研究。
4.1.8. Design validation. Each manufacturer shall establish and maintain procedures for validating the product design. The validation of the project should be carried out under predetermined operating conditions on initial production batch or unit. The design validation must ensure that the product meets user needs and indication for use and should include testing of the products in real or simulated conditions of use. The design validation must
include the validation software when appropriate. The results of the design validation, including identification, methods, data and physical or electronic signature of the responsible should be documented in the historical record of the project. Should be conducted stability studies where applicable.
4.1.9.项目发布每个厂商应确保项目在指定人员批准之前不得投入生产。项目发布前，指定人员应审查项目所有历史记录，确保记录的完整性，同时保证最终设计版本与审批的计划相符。项目发布的过程，包括日期和/或负责人签名电子版必须记录在案。
4.1.9. Release project. Each manufacturer shall ensure that the project is not released for production until it is approved by the persons designated for such by the manufacturer. Appointees shall review all records required for the historical record of the project, to ensure it is complete and that the final design is compatible with the approved plans, prior to their release. This release, including date and or electronic signature of the person responsible, must be documented.
4.1.10.设计变更每个厂商应建立并维护设计变更实施前的鉴定、记录、确认、审查和批准程序，包括风险管理流程内的风险评估。
4.1.10. Design changes. Each manufacturer shall establish and maintain procedures for the identification, documentation, validation, review and approval
of design changes before their implementation, including a risk assessment within the risk management process.
4.1.11.项目历史记录每个厂商应建立并维护每款产品的项目历史记录。项目历史记录应包含或参照所以必要记录，证明项目开发过程符合批准的设计计划以及本技术规范的要求。
4.1.11. Historical record of the project. Each manufacturer shall establish and maintain a historical record of the project for each product. The historical record of the project shall contain or make reference to all records necessary to demonstrate that the project was developed in accordance with the approved design plan and the requirements of this Technical Regulation.
4.2.产品主记录(PMR)/设备主记录(DMR)
4.2. Product Master Record (PMR)/Device Master Record (DMR)
4.2.1.每个厂商应维护产品主记录（器械主文档)。每种类型产品的器械主文档应包含或参照以下信息：
4.2.1. Each manufacturer shall maintain the product masters records (DMR). The DMR for each type of product should include or refer to the following information:
4.2.1.1.产品规范，包括设计、构成、配方、组件规范、软件设计规范及其源代码； 4.2.1.1. Product specifications, including their designs, composition, formulation, component specifications, design specifications of the software and its source code;
4.2.1.2.生产流程规范，包括基础设施和设备的规范、生产方法和说明以及生产环境规范等；
4.2.1.2. Specifications of the production process, including specifications of infrastructure, equipment, methods and instructions for production and environmental specifications of production;
4.2.1.3.包装和标签规范，包括使用的方法和工艺。
4.2.1.3. Packaging and labeling specifications, including methods and processes used;