17 Documentation 文档

17.1 Principle 原则

17.1.1 Each company should establish, design, install and maintain its own system of documentation that is appropriate to its organizational structure and to the type of products. An electronic system can be used to prepare and manage documents.

每个公司应该策划、制订，设置和维护适合组织结构和产品类型的文件系统，电子文件系统可被用来准备和管理文件。

17.1.2 Documentation is an integral part of Good Manufacturing Practices. Therefore, the objective of documentation is to describe activities defined in these guidelines in order to relate the history of these activities and to prevent risks of interpretation, loss of information, confusion or errors inherent to verbal communication.

文件是 GMP 不可或缺的部分，因此，其目的在于描述规定范围内的活动，记录这些活动并且减少在口头交流中出现的信息丢失，不理解或者错误这些风险。

17.2 Type of document 文件类型

17.2.1 Documents should be composed of constituents such as procedures, instructions, specifications, protocols, reports, methods, and records appropriate to the activities covered by these guidelines.

文件应由程序，规定，说明书，协议，报告，方法和记录表组成，当然是在规定范围内的。

17.2.2 Documents can be hard-copy papers or electronic data processing records.

文件可以是书面的也可以是电子档的。

17.3 Writing, approval and distribution 编写，审批和发放。

17.3.1 Documents should be defined and describe, with appropriate detail, the operations to be carried out, precautions to be taken and measures to be applied in all activities connected with these guidelines.

文件应描述操作方法，预防措施和一些其它措施，利用文件指导、规范相关的活动。