文件的分类与编码SOPWord格式文档下载.docx

1、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:版本号变更日期Changing Date变更内容摘要Abstract of Changing Contents建立文件 File foundation1.PURPOSE 目的 1.1.The purpose of this SOP is to define an appropriate code number system for the entire documentation at Jialin Pharma

2、ceutical 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 app

3、lied 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-Category 细分类Detail Category 备注Remark生产质量管理文件Productio

4、n and quality management files标准Standard技术标准Technology standard工艺规程 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 standard生产管理 Production management质量管理 Quality mana

5、gement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岗位SOP Post SOP人员职责、人员更衣、环境监测、设备校验SOP等 Personnel responsibilities, clothes changing, environmentmonitoring, equipment calibration SOP and etc.记录Record验证记录Validation

6、 record编号参见3.3.2规定Code see 3.3.2 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 质量管理记录Quality management record批检验记录 Batch inspection records审计、投诉、召回等 Audit, complain, recall and etc.1.1 T

7、echnical 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 Ma

8、nagement 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:

9、 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 lif

10、e 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 di

11、fferent 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

12、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：文件类别Item总分类号Item code细分类

13、文件类别Section细分Section codeSub-sectionSub-section code质量Quality01总述Summary质量管理手册Quality management handbook质量保证Quality assurance02管理文件Management file质量检验Quality control03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 materiel中间产品质

14、量标准Specifications of intermediates成品质量标准Specification of finished products05介质质量标准Specifications of medias06检验规程Analytical instruction原料质量标准清洗残留量检验规程Analytical instruction of cleaning residual amount07其它Others08检验SOPQuality control SOP取样Sampling环境监测Environmental monitoring标定Standardization稳定性试验Stabi

15、lity testOOS机构与人员Organization and personnel机构、人员管理Organization and Personnel managementSOP部门职责Department responsibility各部门职责Responsibility of each department岗位职责Position responsibility总经理办公室General manager管理委员会Administration committeesQA/ QC部QA/ QC department生产技术部Production & technology department仓

16、库Warehouse设备工程部Equipment department供应部Supply department开发部R&D department行政Administration09财务Finance department10销售部Sales department11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 facility管理SOPManagement SOP厂房、建筑管理Building and roomsmanagement房

17、间手册Room bookQA部QA departmentQC 部QC department行政办公楼Administration office building设备Equipment管理设备技术手册Equipment technique manual公共系统设备Equipment in public system质量控制仪器设备Apparatus in quality control dept.仓库Equipment in warehouse水系统设备Equipment in water supply units空调系统设备Equipment in HVAC-system设备仪器校正Calib

18、ration of equipment and apparatus设备维护、保养Maintenance物料Materials仓库布局图Layout of warehouse仓库管理Warehouse management物料管理Material management确认与验证Qualification and Validation主计划和管理SOPMaster plan and Management SOP主计划Master plan验证/确认分计划Sub-VMP and Sub-QMP房间Room设备和仪器Equipment and apparatus质量检验仪器设备注射剂车间设备水系统Wa

19、ter system纯化水Purity water注射用水Water for injectionQC纯化水系统QC purity water空调Air conditionQC检验QC test取样室Sampling room分析方法Analytical method含量测定Assay有关物质Related substance残留溶剂Residual solvents微生物限度Microbial limit无菌Sterility内毒素Endotoxin微生物Microbe清洗残留量Cleaning residual amount工艺Process灭菌验证Sterilization process

20、 validationQC部消毒工艺验证Disinfection process validation清洗CleaningAPI容器API Container隔离器Isolator工具Tool其他传递Transfer服装类Clothes文件Documents格式Format生产Manufacture工艺规程Manufacturing instruction口服固体工艺规程Manufacturing instructions of Oral solid preparation注射剂工艺规程Manufacturing instructions of injection车间SOPSOP in workshops