文件_文件的分类与编码作业指导.doc

文件题目Document Title文件的分类与编码SOPSOP - Taxonomy and code of GMP documents文件编号Document Code文件版本号Version Code00 (2011)文件种类Category of Document管理类Management发放部门Department of IssueQA 人员 Person类别 Category姓名/职位Name /Position签名Signature日期Date编写人Compiled by审核人Check by批准人Approved by生效日期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Manager12345678910文件变更历史：History of document changing:版本号Version Code变更日期Changing Date变更内容摘要Abstract of Changing Contents00 (2011)2011.05.16建立文件 File foundation1. SOP的目的 Purpose / aim 建立公司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。The purpose of this SOP is to define an appropriate code number system for the entire documentation at HUIYU 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. 2. 适用范围 Scope of application 本文件适用于公司所有文件，包括各类标准、记录、报告。This taxonomy/code number system must be applied to all documentation of our company, including all kinds of standards, records and reports.3. 文件分类 Taxonomy of documentation3.1 文件的种类Category of document文件的种类详见下表：Types of document see below table: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Production 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 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岗位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, environmentmonitoring, equipment calibration SOP and etc.记录Record验证记录Validation 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其它：审计、投诉、召回等Others: Audit, complain, recall and etc.3.1.1 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。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.3.1.2 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。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.3.1.3 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。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.3.1.4 记录：反映实际生活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。Record: Reflect the result of implementing standards in actual life activities such as ledgers, operation record, sheets, cards and boards showing postural.3.2文件分类号 Classification code of document3.2.1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。 At first, GMP documentation is classified into 12 items (Quality, Organization and personnel, Premises and facility, Equipment, Materials, Qualification and Validation, Documents, Manufacture, Sanitation, Product delivery and recall, Audit) according to different management contents. This includes management standards, operation standards and related records.3.2.2各文件类别总分类号依次为 。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 。具体分类见下表：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 . The following table itemise the structure in detail. 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Sub-section code质量Quality 01总述Summary01质量管理手册Quality management handbook01质量保证Quality assurance02管理文件Management file 01质量检验Quality control 03管理文件Management file 01质量标准Specification04原料质量标准Specifications of API 01辅料质量标准Specification of excipients02包材质量标准Specification of packaging materiel 03中间产品质量标准Specifications of intermediates 04成品质量标准Specification of finished products 05介质质量标准Specifications of medias06检验规程Analytical instruction05原料质量标准Specifications of API 01辅料质量标准Specification of excipients02包材质量标准Specification of packaging materiel 03中间产品质量标准Specifications of intermediates 04成品质量标准Specification of finished products 05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Sampling 01环境监测Environmental monitoring 02标定Standardization03稳定性试验Stability test04OOS05机构与人员Organization and personnel 02机构、人员管理Organization and Personnel management 01SOP01部门职责Department responsibility02各部门职责Responsibility of each department01岗位职责 Position responsibility03总经理室General manager01委员会Committees02QA/ QC部QA/ QC department03生产技术部Production & technology department04仓 库Warehouse 05设备工程部Equipment department 06供应部Supply department07开发部R&D department08行政Administration09财务Finance department10销售部Sales department11注射剂车间 Injection workshop12中试车间Pilot workshop13厂房与设施Premises and facility03管理SOPManagement SOP01厂房、建筑管理Building and roomsmanagement01房间手册Room book 02QA部QA department01QC 部QC department02仓 库Warehouse 03设备工程部Equipment department 04开发部R&D department 05行政办公楼Administration office building 06注射剂车间 Injection workshop07中试车间Pilot workshop08设备Equipment04管理Management 01SOP01设备技术手册Equipment technique manual02公共系统设备 Equipment in public system 01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-system05注射剂车间 Injection workshop06中试车间Pilot workshop07设备仪器校正Calibration of equipment and apparatus03公共系统设备 Equipment in public system 01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-system05注射剂车间 Injection workshop06中试车间Pilot workshop07设备维护、保养Maintenance04公共系统设备 Equipment in public system 01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-system05注射剂车间 Injection workshop06中试车间Pilot workshop07物料Materials05SOP01仓库布局图Layout of warehouse 01仓库管理Warehouse management 02物料管理Material management 03确认与验证Qualification and Validation06主计划和管理SOPMaster plan and Management SOP01主计划Master plan01验证/确认分计划Sub-VMP and Sub-QMP02管理SOPManagement SOP03房间Room02QA部QA department01QC 部QC department02仓 库Warehouse 03设备工程部Equipment department 04开发部R&D department 05行政办公楼Administration office building 06注射剂车间 Injection workshop07中试车间Pilot workshop08 设备和仪器Equipment and apparatus03公共系统设备Equipment in public system01质量检验仪器设备Apparatus in quality control dept.02注射剂车间设备Injection workshop 03仓库Equipment in warehouse04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车间workshop01QC检验QC test02取样室Sampling room03分析方法Analytical method 06含量测定Assay01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注射剂车间 Injection workshop01中试车间Pilot workshop02灭菌验证Sterilization process validation08QC部QC department01注射剂车间 Injection workshop02中试车间Pilot workshop03消毒工艺验证Disinfection process validation09注射剂车间 Injection workshop01中试车间Pilot workshop02清洗Cleaning10设备Equipment01隔离器Isolator02工具Tool03其他Others11传递Transfer01服装类Clothes02其他Others03文件Documents07管理Management 01SOP01格式Format 02生产Manufacture08管理Management 01SOP01工艺规程Manufacturing instruction02注射剂工艺规程Manufacturing instructions of injection 01车间SOPSOP in workshops03注射剂车间 Injection workshop01中试车间Pilot workshop02卫生Sanitation09管理Management01卫生主文件HMP01质量管理Quality management02人员 Personnel 01设备Equipment 02岗位Location03仓库Warehouse 03人员 Personnel 01设备Equipment 02岗位Location03设备工程部Equipment engineering dept.04人员 Personnel 01设备Equipment 02岗位Location03注射剂车间 Injection workshop05人员Personnel 01设备Equipment 02岗位Location03中试车间Pilot workshop06人员Personnel 01设备Equipment 02岗位Location03其它Others07人员Personnel 01设备Equipment 02岗位Location03委托生产与委托检验Contract production and test10生产Production01委托生产Contract production01检验Test 02委托检验Contract test 01产品发运与召回Production delivery and recall11 SOP01销售管理Sale management01投诉Complaints02召回Recall03审计Audit 12SOP01自检Self-inspection 01供应商审计Supplier audit 02接受审计检查Audited procedure03委托生产、检验单位审计Contract production and test unit audit043.3文件的编码 Definition of Code number system 3.3.1 标准类文件编码的格式Code number system of standard documentation . . - 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 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。Item: Documentation is classified according to the different management contents, and the code is defined by numbers from 01 to 12.细分类号：需要对文件进行细分类的号，依次为01、02、03。Section or subsection: Documentation is subdivided into section and subsection and the codes possess numbers beginning with 01, 02, 03.文件序列号：用阿拉伯数字001依顺序三位数开始编排下去。Sequence number of documentation beginning with Arabic numerals 001. 版本号：用阿拉伯数字00依顺序二位数开始编排下去。Version number: Expressed by Arabic numerals such as 00, 01, 02,. 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“ - QP / VP；确认报告/验证报告则在相应的文件编号后面加“ - QR / VR”Code