文件的分类与编码SOP

1、二:黑簿:Z General Procedure程序文件从需黑Number / version:编号1版木号;07-01-01-002/00Document name:文档名称文件的分类与编码程序Taxonomy and code of documents文件题目.Document Title文件的分类与编码程序Taxonomy and code of documents文件编号Document Code07-01-01-002-00文件版本号Version Code00文件种类Category of Document管理类Manasement发放部门Department of IssueQA

2、人员Person类别 Category姓名 1职”.Name /PositionSignature日期 Date编号人Compiled by审核人Check by批准人Approved by生期日期Valid from文件分发部门：（）Department of document distributed:序号Serial No.部门名称Department Name房间号Room No.负责人Manager123456文件变更历史：History of document changing:固本号Version Code变更日期Changing Date变更内容殖要Abstract of Cha

3、nging Contents00建立文件File foundation建立文件File foundationFrom here the Entering Firm name or logo 在这里输入公司名称或有公司标志Document name:文档名称:文件的分类与编码Taxonomy and code of documentsNumber / version:编号 1版本号:07.01.01-002-001. PURPOSE 目的1.1. The purpose of this SOP is to define an appropriate code number system for

4、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.

5、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:总分类Category次分类Sub-Catesory

6、细分类Detail Category备注Remark生产质量管 理文件 Production and quality managemen t files标准Standard技术标准Technology standardl：艺规程 Production instrument文件编号参见 3.3.1文件分 类号规定 Document classification code see 3.3.1 document code rule检验规程 Analysis instrument质量标准 Quality specification验证方案 Validation plan管理标准Management s

7、tandard七产管理 Production management质量管理 Quality management卫生管理 Hygiene management验证管理 Validation management其它：职责、文件管理等Others: Responsibilities, document management and etc.工作标准Work standard闵位 SOP Post SOP其它：人员职责、人员更衣、环境监测、 设备校验SOP等Others: Personnel responsibilities, clothes changing, environment monit

8、oring, equipment calibration SOP and etc.记录Record验证记录Validation record编号参见3.32规定Code see3.3.2 rule销售记录Distribution record监测维修校验记录 Check, repair and calibration record生产管理记录Production record物料管理记录Material management records批生产记录 Batch production records质型管理记录Quality management record批检验记录 Batch inspe

9、ction records其它：审计、投诉、召回等Others: Audit, complain, recoil and etc.From here the Entering Firm name or logo 在这里输入公司名称或有公司标志Document name:文档名称:文件的分类与编码Taxonomy and code of documentsNumber / version:编号 1版本号:07.01.01-002-00 3.1.1 Technical standard document: Written requirement like technical standards,

10、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 c

11、reated 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 jobresponsibilities and job content

12、 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 b

13、oards 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,

14、 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

15、subsections. The code of sections or sub-sections are 01、02、03 Thefollowing 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、03o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：文件类别 Item总分类号Item code细分类文件类别 Section细分 类号 Section code细分类文件类别Sub-section细分 类号 Subsectio

16、n code质量 Quality01总述Summary01质量管理手册 Quality management handbook01质量保证 Quality assurance02管理文件 Management file01质量检验Quality control03管理文件 Management file01Jialin PharmaceuticalThis document is uncontrolled if printed outPage 3 of 12From here the Entering Firm name or logo 在这里输入公司名称或有公司标志Document name

17、:文档名称:文件的分类与编码Taxonomy and code of documentsNumber / version:编号 1版本号:07.01.01-002-00文件类别 Item总分类号Item code细分类文件类别 Section细分 类号 Section code细分类文件类别 Sub-section细分 类号 Subsection code质量标准 Specification04原料质量标准0Specifications of API001辅料质量标准 Specification of excipients002包材质量标准 Specification of packaging

18、 materiel03中间产品质量标准 Specifications of intermediates04成品质量标准 Specification of finished products05介质质量标准Specifications of medias06检验规程Analytical instruction05原料质量标准Specifications of API01辅料质量标准 Specification of excipients02包材质量标准 Specification of packaging materiel03中间产品质量标准 Specifications of intermed

19、iates04成品质量标准 Specification of finished products05介质质量标准 Specifications of medias06清洗残留量检验规程 Analytical instruction of cleaning residual amount07其它Others08检验SOPQuality control SOP06取样Sampling01环境监测 Environmental monitoring02标定Standardization03稳定性试验Stability test04oos05From here the Entering Firm nam

20、e or logo 在这里输入公司名称或有公司标志Document name:文档名称:文件的分类与编码Taxonomy and code of documentsNumber / version:编号 1版本号:07.01.01-002-00文件类别 Item总分类号Item code细分类文件类别 Section细分 类号 Section code细分类文件类别 Sub-section细分 类号 Subsection code机构与人员Organization and personnel02机构、人员管理Organization and Personnel management0ISOP0

21、1部门职责 Department responsibility02各部门职责 Responsibility of each department01岗位职责Position responsibility03总经理办公室General manager01管理委员会Administration committees02QA/ QC 部QA/ QC department03生产技术部 Production & technology department04仓库 Warehouse05设备工程部Equipment department06供应部Supply department07开发部R&a

22、mp;D department08行政Administration09财务Finance department10销售部Sales departmentII口服固体制剂车间 Oral solid preparation workshop12注射剂车间Injection workshop13中试车间Pilot workshop14厂房与设施 Premises and facility03管理SOPManagement SOP01厂房、建筑管理Building and rooms management01房间手册Room book02QA部 QA department01QC部QC departm

23、ent02仓库 Warehouse03设备工程部Equipment department04开发部R&D department05From here the Entering Firm name or logo 在这里输入公司名称或有公司标志Document name:文档名称:文件的分类与编码Taxonomy and code of documentsNumber / version:编号 1版本号:07.01.01-002-00文件类别 Item总分类号Item code细分类文件类别 Section细分 类号 Section code细分类文件类别 Sub-section细分 类

24、号 Subsection code行政办公楼 Administration office building06口服固体制剂车间 Oral solid preparation workshop07注射剂车间Injection workshop08设备Equipment04管理 Management01SOP01设备技术手册Equipment technique manual02公共系统设备Equipment in public system01质量控制仪器设备 Apparatus in quality control dept.02仓库Equipment in warehouse03水系统设备E

25、quipment in v/ater supply units04空调系统设备Equipment in HVAC-system05口服固体制剂车间 Oral solid preparation workshop06注射剂车间Injection workshop07中试车间 Pilot workshop08设备仪器校正 Calibration of equipment and apparatus03公共系统设备Equipment in public system01质量控制仪器设备 Apparatus in quality control dept.02仓在Equipment in wareho

26、use03水系统设备Equipment in water supply units04空调系统设备Equipment in HVAC-system05口服固体制剂车间 Oral solid preparation workshop06注射剂车间Injection workshop07From here the Entering Firm name or logo 在这里输入公司名称或有公司标志Document name:文档名称:文件的分类与编码Taxonomy and code of documentsNumber / version:编号 1版本号:07.01.01-002-00文件类别

27、Item总分类号Item code细分类文件类别 Section细分 类号 Section code细分类文件类别 Sub-section细分 类号 Subsection code中试车间 Pilot workshop08设备维护、保养 Maintenance04公共系统设备Equipment in public system01质量控制仪器设备 Apparatus in quality control dept.02仓库Equipment in warehouse03水系统设备Equipment in water supply units04空调系统设备Equipment in HVAC-s

28、ystem05口服固体制剂车间 Oral solid preparation workshop06注射剂车间Injection workshop07中试车间Pilot workshop08物料Materials05SOP01仓库布局图Layout of v/arehouse01仓库管理Warehouse management02物料管理Material management03确认与验证Qualification and Validation06主计划和管理SOPMaster plan and Management SOP0I主计划Master plan01验证/确认分计划Sub-VMP an

29、d Sub-QMP02管理SOP Management SOP03房间Room02QA部 QA department01QC部QC department02仓库 Warehouse03设备工程部Equipment department04开发部R&D department05行政办公楼 Administration office building06口服固体制剂车间 Oral solid preparation workshop07注射剂车间Injection workshop08中试车间Pilot workshop09设备和仪器Equipment and apparatus03公共系

30、统设备Equipment in public system01质量检验仪器设备02From here the Entering Firm name or logo 在这里输入公司名称或有公司标志Document name:文档名称:文件的分类与编码Taxonomy and code of documentsNumber / version:编号 1版本号:07.01.01-002-00文件类别 Item总分类号Item code细分类文件类别 Section细分 类号 Section code细分类文件类别 Sub-section细分 类号 Subsection codeApparatus i

31、n quality control dept.口服固体制剂车间 Oral solid preparation workshop03注射剂车间设备 Injection workshop04仓库Equipment in warehouse05水系统Water system04纯化水Purity water01注射用水Water for injection02QC纯化水系统QC purity water03空调Air condition05口服固体制剂车间 Oral solid preparation workshop01注射剂车间Injection workshop02QC检验QC test03取

32、样室Sampling room04分析方法Analytical method06含量测定 Assay001有关物质Related substance02残留溶剂Residual solvents03微生物限度Microbial limit04无菌Sterility05内毒素 Endotoxin06微生物Microbe07清洗残留量 Cleaning residual amount08工艺 Process07口服固体制剂车间 Oral solid preparation workshop01注射剂车间Injection workshop02中试车间Pilot workshop02灭菌验证 Ste

33、rilization process validation08QC部QC department01口服固体制剂车间 Oral solid preparation workshop02From here the Entering Firm name or logo 在这里输入公司名称或有公司标志Document name:文档名称:文件的分类与编码Taxonomy and code of documentsNumber / version:编号 1版本号:07.01.01-002-00文件类别 Item总分类号Item code细分类文件类别 Section细分 类号 Section code细

34、分类文件类别 Sub-section细分 类号 Subsection code注射剂车间Injection workshop03中试车间Pilot workshop04消毒工艺验证 Disinfection process validation09口服固体制剂车间 Oral solid preparation workshop01注射剂车间Injection workshop02中试车间Pilot workshop03清洗CleaningIO设备Equipment01API容器API Container02隔离器Isolator03工具Tool04其他Others11传递Transfer0I服

35、装类Clothes02其他Others03文件Documents07管理 Management01SOP01格式Format02生产 Manufacture08管理Management0ISOP01工艺规程 Manufacturing instruction02口服固体工艺规程Manufacturing instructions of Oral solid preparation01注射剂工艺规程 Manufacturing instructions of injection02车间SOPSOP in workshops03口服固体制剂车间 Oral solid preparation wor

36、kshop01注射剂车间Injection workshop02中试车间 Pilot workshop03卫生Sanitation09管理Management01卫生主文件HMP01质量管理Quality management02人员Personnel01设备Equipment02From here the Entering Firm name or logo 在这里输入公司名称或有公司标志Document name:文档名称:文件的分类与编码Taxonomy and code of documentsNumber / version:编号 1版本号:07.01.01-002-00文件类别 I

37、tem总分类号Item code细分类文件类别 Section细分 类号 Section code细分类文件类别 Sub-section细分 类号 Subsection code岗位Location03仓库 Warehouse03人员Personnel01设备Equipment02岗位Location03设备工程部 Equipment engineering dept.04人员 Personnel01设备Equipment02岗位Location03口服固体制剂车间 Oral solid preparation workshop05人员Personnel01设备Equipment02岗位Loc

38、ation03注射剂车间Injection workshop06人员Personnel01设备Equipment02岗位Location03中试车间Pilot workshop07人员Personnel01设备Equipment02岗位Location03其它Others08人员 Personnel01设备Equipment02岗位Location03委托生产与委托检Contract production and test10生产 Production01委托生产Contract production01检验Test02委托检验Contract test01产品发运与召回 Production

39、 delivery and recall11SOP01销售管理Sale management0I投诉Complaints02召回 Recall03审计I201自检0IFrom here the Entering Firm name or logo 在这里输入公司名称或有公司标志Document name:文档名称:文件的分类与编码Taxonomy and code of documentsNumber / version:编号 1版本号:07.01.01-002-00文件类别 Item总分类号Item code细分类文件类别 Section细分 类号 Section code细分类文件类别 S

40、ub-section细分 类号 Subsection codeAuditSelf-inspection供应商审计Supplier audit02接受审计检查Audited procedure03委托生产、检验弟位审计 Contract production and test unit audit0. 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 XX. XX. XX - XXXX X；/ I ! 总分类号 细分类号细分类号 文

41、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、12o 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