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

1.2.12.批次：来自同一生产或消毒周期的，关键特性相同的产品之数量。

1.2.12. Lot or batch: quantity of a product produced in a cycle of manufacturing or sterilization, whose essential characteristic is homogeneity.

1.2.13.原材料：用于生产或促进生产的材料或物质，包括清洁剂、脱模剂、润滑剂、消毒剂或生产流程中的其他副产品。 原材料：

1.2.13. Manufacturing Material: material or substance used in the manufacturing process or to facilitate this process, including cleaning agents, mold release agents, lubricants, sterilizing, or other byproducts of the manufacturing process.

1.2.14.不合格: 未满足事先规定的各项要求。

1.2.14. Nonconformity: non-fulfillment of requirements specified in advance.

1.2.15.序号或批号：可追溯采购、制造、包装、贴标及成品分销信息的唯一字母/数字/字母+数字组合。

1.2.15. Serial Number or Lot: distinctive combination of letters or numbers, or both, which can be given a complete history of purchasing, manufacturing, packaging, labeling and distribution of finished products.

1.2.16.危害：潜在风险。

1.2.16. Hazard: Potential source of harm.

1.2.17.质量政策：行政管理人员明示的组织关于质量的一切目的与指示。

1.2.17. Quality Policy: all the intentions and directives of an organization with regard to quality, expressed by executive management.

1.2.18. 特殊工艺：无法通过后续检查与测试充分核实结果的任何流程。

1.2.18. Special Process: any process whose results cannot be fully verified by subsequent inspection and testing.

1.2.19.生产：制造产品所涉及的所有运作，从接收成分、处理、包装，到实现成品。

1.2.19. Production: all operations involved in the manufacture of a product, from receipt of components, through processing and packaging, to obtain the finished product.

1.2.20.成品：适合使用的已包装或已贴标的产品或配件。

1.2.20. Finished product: any product or accessory suitable for use, packed, labeled.

1.2.21.质量：使某一医疗用品或体外诊断用品符合使用要求（包括安全与性能）的全体功能与特点。

1.2.21. Quality: the totality of features and characteristics that enable a medical product or product for diagnostic use in vitro meet the requirements of fitness for use, including safety and performance.

1.2.22.投诉：否定产品特性、质量、耐用性、安全性、效果或性能的书面、口头或电子沟通。

1.2.22. Complaint: written communication, oral or electronic on the rejection of identity, quality, durability, reliability, safety, effectiveness, or performance of a product.

1.2.23.记录：符合标准与质量系统程序要求的，展示数据、事实、特定情况及成果的纸质或电子文件。

1.2.23. Records: physical or electronic document, which shows data, facts, specific events and achievements in relation to compliance with standards and procedures of the quality system.

1.2.24.产品历史记录/设备历史记录(DHR)：成品制造完整历史信息的记录。

1.2.24. Historical record of the product/Device History Record (DHR): compilation of records containing the complete history of producing a finished product.

1.2.25.项目历史记录/设计历史文件(DHF)：从项目到成品的完整历史信息的文件。 1.2.25. Historical record of the project/Design History File (DHF): compilation of documents containing the complete history of the project to a finished product.

1.2.26.产品主记录(PMR)/设备主记录(DMR)：含实现成品、安装、维修与服务的规范、指示与程序的文件。

1.2.26. Product Master Record (PMR)/Device Master Record (DMR): compilation of documents containing specifications, instructions and procedures to obtain a finished product as well as installation, service and maintenance.

1.2.27.返工：用于整改某一不合格成分、中间产品或成品，使其符合产品主记录/设备主记录规范的部分或全部制造活动。

1.2.27. Rework: part or all of the manufacturing operation designed to correct non-conformity of a component, the intermediate product or a finished product, so that it meets the specifications set out in PMR/DMR.

1.2.28.项目/设计审查：项目开发过程中实施的配有文件、系统化且完整实施的检查，用于评估规划与目标的适当性。

1.2.28. Project/Design review: examination documented, systematic and complete performed during the development of the project to assess the adequacy of the same planning and objectives.

1.2.29.风险：发生概率与破坏程度的结合。

1.2.29. Risk: Combination of the probability of occurrence and severity of damage.

1.2.30.质量体系：质量管理的组织化结构、职责、程序、规范、流程及资源。 1.2.30. Quality system: organizational structure, responsibilities, procedures, specifications, processes and resources for quality management.

1.2.31.确认：通过检查与客观证明，验证针对特定目的提出的要求持续获得预期结果。就项目而言，确认指确立并记录客观证据，证明产品规范符合用户需求及其目标用途。就流程而言，确认指确立并记录客观证据，证明流程将持续产生符合既定规范的结果。

1.2.31. Validation: Confirmation by examination and objective evidence that the requirements defined for a particular purpose lead, consistently, the expected result. With respect to a project, means to establish and document objective evidence that the product specifications meet user needs and its intended use. With respect to a process means to establish and document objective evidence that the process will consistently produce a result that meets the predetermined specifications.

1.2.32.验证：检查并提供客观证据，证明满足特定要求。验证流程包括检查某一活动的记录，确定符合确立的规范。

1.2.32. Verification: confirmation by examination and presentation of objective evidence that specified requirements have been met. The verification process includes examining the results of an activity to determine compliance with established specifications.

1.2.33.生命周期：厂商预计产品可正常发挥设计功能的时长。

1.2.33. Life time: time estimated by the manufacturer that a product complies correctly functions for which it was designed.

第2章——质量体系一般要求

CHAPTER 2 - GENERAL REQUIREMENTS OF QUALITY SYSTEM

2.1.总则

2.1. General Provisions

2.1.1.每个厂商应建立并维护一个质量体系，确保满足本技术规范的要求，并保证生产的产品安全、有效，适合预期用途。对于质量体系，每个厂商需要开展下列活动：

2.1.1. Each manufacturer shall establish and maintain a quality system to ensure that the requirements of this Technical Regulation are met and that the products manufactured are safe, effective and appropriate for the intended use. As part of its activities on the quality system, each manufacturer must:

2.1.1.1.根据本技术规范的要求，建立并维护使用说明和有效质量体系程序，并 2.1.1.1. Establish and maintain instructions and effective quality system procedures in accordance with the requirements of this Technical Regulation, and

2.1.1.2.建立符合当前健康法/卫生法/监督法的规定的程序。

2.1.1.2. Establish procedures for compliance with the legal provisions contained in current health/sanitary surveillance laws.

2.2.管理责任

2.2. Managerial responsibility

2.2.1.质量政策。每个厂商的行政管理层的任务包括建立与已有政策一致的可量化政策和目标，以实现质量承诺。行政管理层负责维护组织内各个层级的政策。行