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
2.5.3.每个厂商应根据供应商的能力以及能够满足已有的要求评估并选择潜在供应商，并记录经过审批的供应商。记录评估过程以及结果。
2.5.3. Each manufacturer shall evaluate and select potential suppliers according to their ability to meet the requirements previously established, keeping record of approved suppliers. Records must be kept of the assessment records, as well as their results.
2.5.4.采购记录每个厂商应维护采购订单记录，这些记录应清楚说明或参照相关规范，包括组成部分质量要求、制造材料、要求或合同规定的成品或服务。申请审批，包括日期和/或负责人签名电子版必须记录在案。
2.5.4. Purchase record. Each manufacturer shall maintain records of purchase orders that clearly describe or refer to the specifications, including quality requirements for components, manufacturing materials, finished products or services requested or contracted. The approval of applications, including the date and or electronic signature of the person responsible, must be documented.
2.5.5.必须为供应商承诺通知厂商产品或服务变更的有文件证明的协议，使得厂商能够确定上述变更是否会对成品的质量造成影响。
2.5.5. Must be documented agreement that suppliers undertake to notify the manufacturer of any change in the product or service, so that the manufacturer can determine if the change affects the quality of the finished product.
2.5.6.每个厂商应在采购文件发布之前进行审查和批准。
2.5.6. Each manufacturer shall review and approve purchasing documents before their release.
第3章——质量相关的文件和记录
CHAPTER 3 - DOCUMENTS AND RECORDS OF QUALITY
3.1.一般要求
3.1. General requirements.
3.1.1.每个厂商应建立并维护文件控制程序，确保本技术规范中提及的所有文件均保持正确，并适用于预期用途，同时保证可能对产品质量造成影响的所有员工理解并掌握相关文件。
3.1.1. Each manufacturer shall establish and maintain document control procedures to ensure that all documents referenced in this Technical Regulation
are correct and suitable for the intended use, and are understood by all employees who may affect or influence the quality of a product.
3.1.2.文件审批和发放每个厂商应指定人员审查和批准本技术规范中规定的所有文件内容是否充分，然后才能发放。批准的过程，包括日期和审批人签名的电子版必须附有文件证明。
3.1.2. Approval and issuance of documents. Each manufacturer shall designate persons to review and approve all documents set forth in this Technical Regulation for adequacy prior to issue. The approval, including the date and or electronic signature of the person responsible for approving the document, shall be documented.
3.1.3.文件分发厂商应确保所有的文件应及时更新，并且在使用场合能够获得，同时应该保证回收所有不必要和老旧的文件，避免非预期使用。
3.1.3. Distribution of documents. The manufacturer shall ensure that all documents are updated and available at the sites of application and that all unnecessary or obsolete documents are removed from use, or protected from unintended use.
3.1.4.文件变更质量体系相关规范、方法或程序的变更必须由与原来审查人和批准人职位或职责等级相当的人员进行评估、记录、审查和批准。
3.1.4. Change documents. Changes in specifications, methods or procedures relating to the quality system must be evaluated, documented, reviewed and approved by people whose role and level of responsibility are equivalent to those that performed the original review and approval.
3.1.5.记录文件变更每个厂商应维护文件变更记录，包括变更说明、受影响和变更文件鉴定、责任人鉴定、批准日期和变更生效日期。
3.1.5. Records document changes. Each manufacturer shall maintain records of changes to documents shall contain a description of the change, identification of affected and altered documents, identification of the responsible person, date of approval and date on which the changes will take effect.
保存文件当前清单，确定文件当前状态并确保只使用经批准的当前文件。
Should be kept current list of documents to identify the current status of the same and ensure that they use only current and approved documents.
3.1.6.文件档案和记录所有文件和质量记录应清晰可辨，并储存起来将损坏降低至最小，防止文件丢失，并提供快速恢复。所有以电子方式保存的文件和记录应进行备份：
3.1.6. Document Archive and Records. All documents and quality records shall be legible and be stored to minimize damage, prevent loss and provide fast recovery. All documents and records digitally stored should be backed up:
3.1.6.1.保密性厂商认定的保密文件和记录需要进行标记，以提醒有关卫生当局。新增
3.1.6.1. Confidentiality. The documents and records deemed confidential by the manufacturer may be marked to alert the competent health authority;
3.1.6.2 文件和记录的保留周期：文件记录的保存期限因不低于产品的使用寿命期限，但是不得少于文件分发日期后的两年。 不同
3.1.6.2 Period of retention of documents and records: all records and documents necessary relating to a product should be kept for a period of time equivalent to the useful life time of the product, but in no case for less than two years from the date the distribution thereof.
3.2.产品/设备历史记录(DHR)
3.2. Historical record of the product/ Device History Record (DHR)
3.2.1.每个厂商应维护产品的历史记录。每个厂商应建立并维护相关程序，确保产品的历史记录分批或按照不同系列保存，证明产品是根据本技术规范要求和产品主记录进行生产。产品的历史记录应包含或参照以下信息：
3.2.1. Each manufacturer shall maintain historical records of products. Each manufacturer shall establish and maintain procedures to ensure that the historical records of products are kept for each batch or series to demonstrate that the products were manufactured according to the master record of the product and the requirements of this Technical Regulation. The historical record of the product should include or refer to the following information:
3.2.1.1.生产日期；
3.2.1.1. Date of manufacture ; 3.2.1.2.产品部件；
3.2.1.2. Components used;
3.2.1.3.生产数量；
3.2.1.3. Quantity manufactured; 3.2.1.4.检验和测试结果；
3.2.1.4. Results of inspections and tests; 3.2.1.5.特殊过程的参数；
3.2.1.5. Parameters of special processes; 3.2.1.6.放行数量；
3.2.1.6. Quantity released for distribution; 3.2.1.7.标签； 3.2.1.7. Labeling;
3.2.1.8. 批量生产的产品序列号；
3.2.1.8. Identifying serial number or batch production, and 3.2.1.9. 最终合格数量；
3.2.1.9. Final release of product.
3.3.检验和测试记录
3.3. Records of inspections and tests.
3.3.1.每个厂商应维护与关键产品质量属性直接相关的检验和测试结果的记录。
3.3.1. Each manufacturer shall maintain records of the results of inspections and tests set forth when they are directly related to critical quality attributes of the product.
这些记录应包含验收标准、结果、使用的设备/仪器、日期和/或负责人签名电子版。
These records should include the acceptance criteria, the results, the equipment / instrument used and date and or electronic signature of the person responsible.
第4章——项目/设计控制和产品主记录(PMR)
CHAPTER 4 - PROJECT/DESIGN CONTROL AND PRODUCT MASTER RECORD (PMR)
4.1.项目控制 4.1. Project Control