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：
3.3.
3.4.Definition of Code number system文件的编码
? 3.3.1 Code number system of standard documentation
?标准类文件编码的格式
?×× . ×× . ×× - ×××××
?
?
?
?总分类号细分类号细分类号文件序列号版本号
? Item Section Sub-section Sequence number Version number
?Item: Documentation is classified according to the different management contents, and the code is defined by numbers from 01 to 12.
?总分类号：公司文件按GMP各管理内容分类，总分类号依次为01、
02、……12。
?Section or subsection: Documentation is subdivided into section and subsection and the codes possess numbers beginning with 01, 02, 03…….
?细分类号：需要对文件进行细分类的号，依次为01、02、03……。
?Sequence number of documentation beginning with Arabic numerals 001.
?文件序列号：用阿拉伯数字001依顺序三位数开始编排下去。
?Version number: Expressed by Arabic numerals such as 00, 01, 02,…….
?版本号：用阿拉伯数字00依顺序二位数开始编排下去。
?Code of Risk Analysis /qualification / validation documentation: for qualification / validation plan, add“-RA /- QP / VP”following the
documentation code; and for qualification / validation report, add“-
QR / VR” in the same manner.
?风险分析、确认、验证方案及报告的编号：确认方案/验证方案则在相应的文件编号后面加“–RA/- QP / VP；确认报告/验证报告则在相应的文件编号
后面加“ - QR / VR”
Example 实例
?例1： Example 1：06 . 07 . 01 - 001 - VP
?Validation . Process validation . Process validation in SVP workshop - Process validation of Oral solid preparation -
?06 . 07 . 01 - 001 - VP
?验证 . 工艺验证 . 口服固体工艺验证–
?例2：Example 2: 01 . 04 . 01 - 001
?Quality .Quality specification . API -
? 01 . 04 . 01 - 001
?质量 . 质量标准 . 原料 -
? 3.3.2 Code number of record sheets 记录类文件的编号
?Record sheets must be designated with the identical code number as defined for the related documentation. The code must comply with the corresponding documentation added by “- R”to the corresponding code. If there are several records to the same documentation, distinguish them according to the following description “ - R1”and “ - R2”……
“ - Rn”
?各种记录与各类文件一一对应，编号同对应的文件编号一致，只是在对应文件编号后面加“- R”表示。如果同一个文件中有多个记录，则用“- R1”
和“ - R2”……“ - Rn”区分。