发布时间 : 星期二 文章New GMP ANVISA Regulation - RDC16 2013 - English Version(1)-对照译文更新完毕开始阅读
政管理层负责确保上述政策包含于质量手册之中，并且所有影响产品质量的员工都理解掌握这些政策。
2.2.1. Quality Policy. The executive management of each manufacturer shall establish its policy and objectives of commitment to quality, which should be measurable and consistent with the established policy. Executive management should maintain the policy at all levels of the organization. Executive management should ensure that this policy is described in a quality manual and understood by all employees who may affect or influence the quality of a product.
2.2.2.组织每个厂商应根据组织系统图，建立并维护适当的组织结构，任命有效率的员工，确保生产的产品符合本技术规范的要求。
2.2.2. Organization. Each manufacturer shall establish and maintain an appropriate organizational structure, represented by the organization chart, with sufficient staff to ensure that products are manufactured in accordance with the requirements of this Technical Regulation.
2.2.3.职责及权限每个厂商应根据本规范中每一章节的要求，落实管理、执行并验证质量相关工作的所有员工的职责、权限和相互关系，并确保员工拥有必要的独立性去完成各自职责。
2.2.3. Responsibility and Authority. Each manufacturer shall establish, for each chapter of this Technical Regulation, responsibility, authority and interrelation of all personnel who manage, perform and verify work relating to quality, with the necessary independence to perform its responsibilities.
2.2.4.待验证的资源与人员每个厂商应确定验证职能，提供充足的资源，任命经培训的人员开展验证活动。
2.2.4. Resources and personnel for verification. Each manufacturer shall establish verification functions, and must provide adequate resources and assignment of trained personnel to carry out verification activities.
2.2.5.管理层代表每个厂商的行政管理层应指派一个人作为代表，并将任命决定记录存档。在不考虑其他职能的情况下，受任命的代表有以下权限和职责：
2.2.5. Management representative. The executive management of each manufacturer shall designate an individual of this, and document this
designation, which, irrespective of other functions, will have authority and responsibility for:
2.2.5.1.确保根据本技术规范的要求建立并维护质量体系要求；
2.2.5.1. Ensure that the requirements of the quality system are established and maintained in accordance with this Technical Regulation;
2.2.5.2.将质量体系的执行情况报告给行政管理层进行审查，并提供改善质量体系的相关信息。
2.2.5.2. Report the performance of the quality system to executive management for review and providing information on the improvement of the quality system.
2.2.6.管理审查每个厂商的行政管理层应根据规定的时间间隔评估质量体系的充分性和有效性，并保证充分的评估次数，确保质量体系满足本技术规范的要求且符合建立的质量政策的目标。管理审查应根据已有的审查程序开展，对质量体系每次审查的结果都应进行记录。
2.2.6. Management review. The executive management of each manufacturer should evaluate the adequacy and effectiveness of the quality system at defined intervals and with sufficient frequency to ensure that the quality system satisfies the requirements of this Technical Regulation, and complies with the objectives of the quality policy established. The management review shall be conducted in accordance with established review procedures and the results of each review of the quality system shall be documented.
且管理审查应考虑与审计结果、上市后信息、过程性能和产品合格性、预防措施和保护措施状态、影响质量体系或产品合规性的变更、法规要求等有关的事宜。 Should be considered for review matters relating to audit results, post-marketing information, process performance and product conformity, status of preventive and corrective actions, changes that could affect the quality system or product compliance, regulatory requirements, among other .
2.3.人事部门
2.3. Personnel
2.3.1.一般说明每个厂商应配备足够的人员，他们的教育、经验、培训和实践经验要与职位责任相符，确保本技术规范中的所有活动都能够正确执行。说明权限、责任和公司各种任务的要求。
2.3.1. General Instructions. Each manufacturer shall have sufficient personnel with education, experience, training and practice consistent with the duties of the position, to ensure that all activities under this Technical Regulation are correctly performed. Should be kept descriptions defining authority, responsibility and requirements for the various tasks of the company.
2.3.2.培训每个厂商应确保所有人员经过充分培训，能够胜任指定的任务。培训需要根据有资格人士确立的程序来开展，确保员工了解他们的常规职责以及本技术规范中适用于他们岗位的要求。
2.3.2. Training. Each manufacturer shall ensure that all personnel are adequately trained to perform the tasks assigned to it. Training shall be conducted in accordance with procedures established by qualified persons to ensure that employees have a proper understanding of their regular duties and requirements of this Technical Regulation applicable to their duties.
培训过程中需要提醒所有员工由于未能正确行使职能可能造成的产品缺陷。
As part of their training, all employees should be warned of defects in products may occur as a result of improper performance of their specific functions.
员工的培训需要进行记录。
The employee training should be documented.
2.3.3.顾问每个厂商应确保每位对员工进行产品设计、采购、制造、包装、贴标签、储存、安装或维修方法和控制进行指导的顾问必须具备足够的资历（教育、培训和经验），才能对职责以内的事项提供建议。
2.3.3. Consultants. Each manufacturer shall ensure that any consultant to guide employees on methods and controls used for the design, purchase, manufacturing, packaging, labeling, storage, installation or servicing of products has sufficient qualifications (education, training and experience) to advise on matters for which he was hired.
顾问的招聘要根据本技术规范中的采购控制要求来执行。 新增
Hiring consultants should be conducted in accordance with the requirements of Purchasing Control under this Technical Regulation.
2.4.风险管理 新增 2.4. Risk Management
2.4.1.每个厂商应建立并维护一个风险管理的持续流程，涉及产品从概念到停用的整个生命周期，以此确定与医疗设备或体外诊断设备产品相关的危害，评估并监控相关风险，同时衡量已有控制过程的有效性。这个流程应包含风险分析、评估、控制和监控等方面。
2.4.1. Each manufacturer shall establish and maintain an continuous process of risk management which involves the entire product life cycle, from conception to its discontinuation, to identify the hazards associated with a medical device or product for in vitro diagnostic use, assess and evaluate the risks involved, monitor them and evaluate the effectiveness of established controls. This program should include the following elements: analysis, evaluation, control and monitoring of risk.
2.4.2.公司行政管理层应指定专业负责人，制定确定风险的可接受性准则的政策，并确定对风险管理行动进行审查的周期，确保风险管理的充分性和有效性。
2.4.2. The executive management of the company shall designate the responsible professionals, establish policy for determining the criteria for acceptability of risk, and determine a periodic review of the risk management activities to ensure the adequacy and effectiveness of the same.
2.5.采购控制
2.5. Purchasing Control
2.5.1.每个厂商应建立并维护相关程序，确保组成部分、生产材料和经他人制造、处理、包装、贴标签或储存的成品与相关规范相符。每个厂商还应确保第三方提供的服务与相关规范相符。
2.5.1. Each manufacturer shall establish and maintain procedures to ensure that components, manufacturing materials and finished products manufactured, processed, packaged or labeled by others or stored by them under the contract, are under conformity with the specifications. Each manufacturer shall also ensure that the services performed by third parties are under conformity with the specifications laid down by it.
2.5.2.供应商产品和服务的评估每个厂商应根据质量对于成品的影响，建立并维护供应商评估标准，并指定供应商应满足的相关要求，包括质量要求。
2.5.2. Evaluation of suppliers of products and services. Each manufacturer shall establish and maintain, according to the impact on the quality of the final product, criteria for evaluating suppliers,; specifying the requirements, including quality requirements, that they should meet.