All Documentation required by GMP Regulation is issued, managed and controlled by a Document Management System such as batch related documents as M-aster Batch Records - Processing and Packaging Instructions, Raw Data Records, Distribution Records, Standard Operating Procedures, Specifications, Test Methods and non batch related documents such as Qualification and Validation Documents, Complaint and Recalls Records, Environmental Monitoring Records, Utility Monitoring Records, Change Control Documentation, Engineering Drawings, Maintenance and Calibration Records, Equipment Logs, Personnel Training Records, Technical Agreements, Investigation and Reporting Records, Cleaning and Sanitization Records, Entry Records for Controlled Areas, Pest Control Records, Stability Records, Audit Reports, Regulatory Files, etc. 按GMP法规要求制订的所有文件由文件管理系统发行、管理与控制，例如与批生产有关的文件，如批生产记录，生产与包装说明，原始数据记录，分发记录，标准操作程序，规格，检测方法；与批生产无关的文件，如确认与验证文件，投诉与召回记录，环境监测记录，设备监控记录，变更控制记录，工程图纸，保养与校正记录，设备日志，人员培训记录，技术协议，调查研究与报告记录，清洁与卫生记录，控制区人员出入记录，蚊虫控制记录，稳定性记录，审计记录，法规文件等。 Modifications to M-aster Documents are managed through Change Control. 主文件的修订按变更控制程序进行管理。 All incoming raw materials are quarantined until all the tests required by the specification have been performed and found to be satisfactory. 所有进厂的原料被隔离，直到按照指定的规格进行检测并且所有检测结果均符合要求。 A numbered copy of the M-aster batch production record is produced for every batch which serves as an Operating Procedure. 将主批生产记录编号后的副本，按操作程序填写每批的批生产记录。（总是难以翻译顺畅） The guidelines used in the packaging and labeling of APIs are defined in approved packaging assembly specifications. The packaging orders are prepared for specified quantities, and whenever possible, an entire batch is packaged at one time. The packaging is performed in a manner such as to avoid mix-ups and prevent cross contamination. 批准的包装规格中规定了APIs包装与贴签的准则。包装量按规定的数量准备，无论如何，一个完整的批号应在一个时间内包装完成。包装以一种方式进行，以避免混批以及预防交叉污染。 Adequate sampling and controls are set for all the critical process steps for each product to ensure that each operation is satisfactory. 每一批生产中所有关键工艺步骤要设定足够的取样与控制，以保证每一批的操作是令人满意的。 Representative samples of the batch are sampled at various intervals during production and processing to ensure quality of the final product. 在生产与操作过程中，以不同的间隔对生产批的代表性样品进行取样，以确保最终产品的质量。
6. Quality Control 质量控制 6.1 Release of batches 批放行 Name and function of the person who have responsibility for the release of Packaging materials, Bulk Products, Raw Material: XX, QA manager 负责包装材料、原料药产品、原辅料的人及其岗位
6.2 Brief description of Quality Control System 质量控制系统简述
Quality Control has a well-equipped laboratory for the physical, analytical and microbiological testing of raw materials, intermediates and Finished API. 质量控制部门有一个设备完善的实验室，负责对原料、中间体以及原料药产品进行物理、化学及微生物检测。 A Quality Control sampler takes samples in a sampling booth according to specific sampling plans. 质量控制部门的取样员根据规定的取样计划在取样间进行取样。 The samples are logged into the laboratory and allocated to the relevant section for testing. 所取样品在实验室登记并分发到相关的检测岗位。 Materials and products are tested according to registered testing specifications. Methods have been validated according to the M-aster Validation Program. 原料及产品根据已注册的测试规格进行测试。检测方法已根据验证主计划进行了验证。 Results are reported on a Laboratory Test sheets and supplied to the relevant Supervisor who reviews the results and gives a final disposition on the material or product tested. 检测结果报告在实验室的测试单上，提供给相关的负责结果审核的管理者并对原料或产品的测试结果给出一个最终的处理。 Release of products entails a Batch Record and Quality Control documentation reviewed prior to release. 产品的放行需要一个批记录以及先前被审核放行的质量控制部门的文件。
[注：我理解为需要批记录以及QC的质量检验合格报告单才能放行]
7. Distribution, Complaints and Product Recalls 分发、投诉与产品召回
A procedure is established for the handling of customer complaints and product recalls. The site SOPs describe all necessary steps, starting from the notification recording, investigation and subsequent actions, which must be carried out for any customer complaint received and potential recall. The content of the investigation include Batch Production Record, retest of reserve samples and test of samples provided by customers. All related complaints and recalls must be recorded, including product name, batch number, receiving date, cause of recall, etc. 建立客户投诉与召回的处理程序。厂地SOPs描述了所有必要的步骤，从通知记录，调查以及后来的行动开始，收到的任何客户投诉以及潜在的召回都必须实施。调查内容包括批生产记录、留样样品的复测以及客户提供样品的测试。必须记录所有的投诉与召回，包括产品名称，批号，收到日期，召回的原因等。
8. Self-inspections 自检
In order to monitor the implementation of good manufacturing practice, any necessary corrective measures and regular internal audits are performed in accordance with an approved schedule. A full general GMP inspection is carried out in each year. In addition, inspections for parts of GMP system will be carried out every month. 为了监控GMP的执行情况，应根据批准的时间表执行任何必要的纠正措施以及定期的内部审计。每年执行一次全面的GMP检查，另外，每个月执行一次GMP系统的部分检查。
When the self-inspection has been completed, QA will discuss the deficiencies observed during the inspection with representatives of the departments. Corrective actions will be completed in a timely and effective manner under the supervision of QA. Audit findings and corrective actions will be documented. 自检完成后，QA将与相关的部门讨论审计中所发现的缺陷，在QA的监督下以及时、有效的方式完成纠正行动。审计结果以及纠正行动记录将被存档保存。 . . . . 结束...
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