New GMP ANVISA Regulation - RDC16 2013 - English Version(1)-对照译文

5.5. 确认

5.5. Validation 5.6.变更控制

5.6. Change Control

第6章——搬运、储存、分销的可追溯性 Part K搬运、存储、交付和安装

CHAPTER 6 - HANDLING, STORAGE, DISTRIBUTION AND TRACEABILITY 6.1.处置

6.1. Handling 6.2. 存贮

6.2. Storage 6.3.分销

6.3. Distribution 6.4.可追溯性

6.4. Identification and traceability 6.5.产品的符合性

6.5. Non-compliant components and products

第7章—— 纠正预防措施 Part J 纠正措施

SECTION 7 - PREVENTIVE AND CORRECTIVE ACTIONS

7.1.纠正和预防措施

7.1. Corrective and Preventive Actions 7.2.投诉的管理

7.2. Management of complaints 7.3.质量审核

7.3. Quality audit

第8章——安装和服务 Part K 搬运、存储、交付和安装 CHAPTER 8 - INSTALLATION AND SERVICING

8.1.安装

8.1. Installation 8.2.技术援助和服务

8.2. Technical Assistance/Servicing

第9章——统计技术 Part O CHAPTER 9 - STATISTICAL TECHNIQUES

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第1章——总则

CHAPTER 1 - GENERAL PROVISIONS

1.1——适用性

1.1 - Applicability

1.1.1.本技术规范说明了对医疗用品与体外诊断用品的制造要求。这些要求说明了医疗用品与体外诊断用品的设计、采购、制造、包装、贴标、存放、配送、安装及维修方法与管理的良好生产规范(GMP)。本技术规范的要求旨在保证医疗用品与体外诊断用品的安全性与有效性。

1.1.1. This Technical Regulation establishes requirements for the manufacture of medical products and products for in vitro diagnostic use. These requirements describe the Good Manufacturing Practices (GMP) for methods and controls used in the design, purchase, manufacturing, packaging, labeling, storage, distribution, installation and servicing of medical products and products for in vitro diagnostic use. The requirements of this Technical Regulation are intended to ensure that medical products and products for in vitro diagnostic use are safe and effective.

1.1.1.2.本技术规范的要求适用于在巴西销售的体外诊断用品的制造商与进口商。 1.1.1.2. The requirements of this Technical Regulation are applicable to manufacturers and importers of medical devices and diagnostic products for use in vitro that are commercialized in Brazil.

1.1.3.制造商认为本决议的任何要求不适用于自身情况的，应提交相应的书面理由说明。

1.1.3. Where the manufacturer understand that any of the requirements of this resolution does not apply to their cases, shall document justification for such understanding.

1.1.1.4.适用时，医疗用品与体外诊断用品的进口商应符合决议要求。

1.1.1.4. Importers of medical and diagnostic products for use in vitro should meet the requirements of this Resolution, as applicable.

1.2.定义

1.2. Definitions

在本技术规范采用下列定义：

For the purposes of this Technical Regulation the following definitions apply:

1.2.1.技术协助/维修：为使成品达到规范要求而开展的维护或维修。

1.2.1. Technical Assistance/Servicing: Maintenance or repair of a finished product to return it to your specifications.

1.2.2.质量审查：一项定期以适当频率开展的，独立于制造商所有质量体系的系统化审查，用于确认质量体系活动或其结果是否符合贵方质量体系程序的要求，确保有效落实程序，实现质量体系目标。质量审查与本技术规范要求的其他质量体系活动不同。

1.2.2. Audit quality: means an established examination, systematic and independent of all quality system from a manufacturer, performed at regular intervals and with sufficient frequency to ensure that either the activities of the quality system or their results satisfy the procedures specified in your quality system, and that these procedures are implemented efficiently and that are appropriate to achieve the objectives of the quality system. The quality audit is different from other activities of the quality system required by this Technical Regulation.

1.2.3.组成部分：医疗用品与体外诊断用品的生产过程中使用的，作为成品组成部分的原材料、物质、组件、零件、软件、硬件、包装、标签或使用说明。

1.2.3. Component: raw material, substance, piece, part, software, hardware, packaging, labeling or instructions for use which are used during the manufacture of a medical product and product for diagnostic use in vitro, to be included as part of the finished product.

1.2.4.项目/设计输入：作为贵方项目依据的物理特性、使用说明、性能、兼容性、安全性、功效、人体工程学理论、可用性、先前项目信息与风险管理结果，以及医疗设备或体外诊断用品的其他要求。

1.2.4. Project /Design Input : description of physical attributes, indication for use, performance, compatibility, security, efficiency, ergonomics, usability, information from previous projects and results of risk management, among other requirements of a medical device or diagnostic product use in vitro that are used as the basis for your project.

1.2.5.项目/设计输出：项目各阶段成果及其最终结果。完成项目的输出数据是产品主记录(PMR)/器械主记录(DMR)的依据。

1.2.5. Project/Design Output : outcome of the work in each phase of the project and its final result. The output data of finished project is the basis for the product master record (PMR)/Device Master Record (DMR) .

1.2.6.损害：对人员健康的物理伤害，或者财产或环境的损坏。

1.2.6. Damage: physical injury or harm to the health of the person, or damage to property or the environment.

1.2.7.规范：各种产品、成分、生产活动、技术协助服务、质量体系或其他活动必须符合的要求。

1.2.7. Specifications: requirements that products, components, production activities, technical assistance services, quality system or any other activity must conform.

1.2.8.确立：定义、记录（通过书面或电子手段）与实施。

1.2.8. Establish: define, document (through written or electronic) and implement.

1.2.9.厂商：负责设计、制造、组装或处理成品的任何人，包括消毒、贴标与包装人。

1.2.9. Manufacturer: means any person who designs, manufactures, assembles or processes a finished product, including those who perform contract sterilization, labeling, packaging.

1.2.10.行政管理层：负责提供资源与授权变更政策与质量体系的高层管理人员。 1.2.10. Executive management: top management responsible for providing resources and authority to establish or change policy and quality system of the company.

1.2.11.风险管理：各种分析、评估、控制与管理特定产品或流程相关风险的政策、程序与管理规范的系统化应用。

1.2.11. Risk Management: the systematic application of policies, procedures and management practices to the tasks of analyzing, evaluating, controlling and monitoring risks associated with a particular product or process.