文件的分类与编码SOP

From here the Entering Firm name

or logo

在这里输入公司名称或者公司标志

General Procedure 程序文件

管理标准

Management standard

文件分发部门：（ ）

文件变更历史：

1.PURPOSE 目的

1.1.The purpose of this SOP is to define an appropriate code number system for the

entire documentation at Jialin Pharmaceutical Limited. The code number

system should facilitate the identification or pursuit of single documents and

must keep the filing system/documentation system clearly arranged.

建立嘉林药业的文件系统和编码系统，使文件条理化和系统化，以利于识别、查询、控制、跟踪和使用。

2.SCOPE OF APPLICATION适用范围

2.1.This taxonomy/code number system must be applied to all documentation of

our company, including all kinds of standards, records and reports.

本文件适用于公司所有文件，包括各类标准、记录、报告。

3.TAXONOMY OF DOCUMENTATION文件分类

3.1.Category of document文件的种类

Types of document see below table: 文件的种类详见下表：

• 3.1.1 Technical standard document: Written requirement like technical standards, rules, specification and procedures created and promulgated

by enterprise such as manufacturing procedures, quality specifications,

analysis instructions and etc.

•技术标准文件：是由企业颁布和制定的技术性规范、规定、标准和规程等书面要求。例如工艺规程、质量标准、检验规程等。

• 3.1.2 Management standard document: Written rules and regulations requirements created by enterprise to exercise management functions as

production planning, commanding and controlling and make it standard.

•管理标准文件：指企业为了行使生产计划、指挥、控制等管理职能，使之标准化、规范化而制定的规章制度类书面要求。例如操作人员卫生制度、原辅

料取样制度等。

• 3.1.3 Job standard document: Written rules and procedures for job responsibilities and job content requirements which consider the job of

staff for object such as job responsibilities, SOPs and etc.

•工作标准文件：指以人或人群的工作为对象，对工作职责、工作内容等所提出的规定、程序等书面要求。例如工作职责、SOP等。

• 3.1.4 Record: Reflect the result of implementing standards in actual life activities such as ledgers, operation record, sheets, cards and boards

showing postural.

•记录：反映实际生产活动中执行标准情况的实施结果。例如台账、操作记录、表示状态的单、卡、牌等。

3.2. Classification code of document文件分类号

• 3.2.1 At first, GMP documentation is classified into 12 items (according to different management contents) according to different management

contents. This includes management standards, operation standards and

related records.

•公司GMP文件按文件类别分为质量、机构与人员、厂房与设施、设备、物料、确认与验证、文件、生产、卫生、委托生产与委托检验、产品发运与召

回、审计等12类。包括：管理标准、操作标准及其实施需要的记录表格。

• 3.2.2 The item codes of documents are defined by numbers from 01 to

12. Subsequent each item of documentation is subdivided in several

sections and several subsections. The code of sections or sub-sections are

01、02、03…… . The following table itemise the structure in detail.

•各文件类别总分类号依次为01至12 。按细分类文件类别对文件总分类进行细分类，细分类号依次为01、02、03……。按部门或文件管理类别再进

行细分类，细分类号依次为01、02、03……。具体分类见下表：