文件的分類與編碼SOP

1、二:黑簿:Z General Procedure程序文件從需黑Number / version:編號(hào)1版木號(hào);07-01-01-002/00Document name:文檔名稱文件的分類與編碼程序Taxonomy and code of documents文件題目.Document Title文件的分類與編碼程序Taxonomy and code of documents文件編號(hào)Document Code07-01-01-002-00文件版本號(hào)Version Code00文件種類Category of Document管理類Manasement發(fā)放部門Department of IssueQA

2、人員Person類別 Category姓名 1職”.Name /PositionSignature日期 Date編號(hào)人Compiled by審核人Check by批準(zhǔn)人Approved by生期日期Valid from文件分發(fā)部門：（）Department of document distributed:序號(hào)Serial No.部門名稱Department Name房間號(hào)Room No.負(fù)責(zé)人Manager123456文件變更歷史：History of document changing:固本號(hào)Version Code變更日期Changing Date變更內(nèi)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 在這里輸入公司名稱或有公司標(biāo)志Document name:文檔名稱:文件的分類與編碼Taxonomy and code of documentsNumber / version:編號(hào) 1版本號(hào):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.建立嘉林藥業(yè)的文件系統(tǒng)和編碼系統(tǒng)，使文件條理化和系統(tǒng)化，以利于識(shí)別、查詢、控 制、跟蹤和使用。2. SCOPE OF APPLICATION 適用范圍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.本文件適用于公司所有文件，包括各類標(biāo)準(zhǔn)、記錄、報(bào)告。3. TAXONOMY OF DOCUMENTATION 文件分類3.1. Category of document 文件的種類Types of document see below table:文件的種類詳見(jiàn)下表:總分類Category次分類Sub-Catesory

6、細(xì)分類Detail Category備注Remark生產(chǎn)質(zhì)量管 理文件 Production and quality managemen t files標(biāo)準(zhǔn)Standard技術(shù)標(biāo)準(zhǔn)Technology standardl：藝規(guī)程 Production instrument文件編號(hào)參見(jiàn) 3.3.1文件分 類號(hào)規(guī)定 Document classification code see 3.3.1 document code rule檢驗(yàn)規(guī)程 Analysis instrument質(zhì)量標(biāo)準(zhǔn) Quality specification驗(yàn)證方案 Validation plan管理標(biāo)準(zhǔn)Management s

7、tandard七產(chǎn)管理 Production management質(zhì)量管理 Quality management衛(wèi)生管理 Hygiene management驗(yàn)證管理 Validation management其它：職責(zé)、文件管理等Others: Responsibilities, document management and etc.工作標(biāo)準(zhǔn)Work standard閔位 SOP Post SOP其它：人員職責(zé)、人員更衣、環(huán)境監(jiān)測(cè)、 設(shè)備校驗(yàn)SOP等Others: Personnel responsibilities, clothes changing, environment monit

8、oring, equipment calibration SOP and etc.記錄Record驗(yàn)證記錄Validation record編號(hào)參見(jiàn)3.32規(guī)定Code see3.3.2 rule銷售記錄Distribution record監(jiān)測(cè)維修校驗(yàn)記錄 Check, repair and calibration record生產(chǎn)管理記錄Production record物料管理記錄Material management records批生產(chǎn)記錄 Batch production records質(zhì)型管理記錄Quality management record批檢驗(yàn)記錄 Batch inspe

9、ction records其它：審計(jì)、投訴、召回等Others: Audit, complain, recoil and etc.From here the Entering Firm name or logo 在這里輸入公司名稱或有公司標(biāo)志Document name:文檔名稱:文件的分類與編碼Taxonomy and code of documentsNumber / version:編號(hào) 1版本號(hào):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. 技術(shù)標(biāo)準(zhǔn)文件：是由企業(yè)頒布和制定的技術(shù)性規(guī)范、規(guī)定、標(biāo)準(zhǔn)和規(guī)程等書 面要求。例如工藝規(guī)程、質(zhì)量標(biāo)準(zhǔn)、檢驗(yàn)規(guī)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. 管理標(biāo)準(zhǔn)文件：指企業(yè)為了行使生產(chǎn)計(jì)劃、指揮、控制等管理職能，使之標(biāo) 準(zhǔn)化、規(guī)范化而制定的規(guī)章制度類書面要求。例如操作人員衛(wèi)生制度、原輔 料取樣制度等。 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. 工作標(biāo)準(zhǔn)文件：指以人或人群的工作為對(duì)象，對(duì)工作職責(zé)、工作內(nèi)容等所提 出的規(guī)定、程序等書面要求。例如工作職責(zé)、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. 記錄：反映實(shí)際生產(chǎn)活動(dòng)中執(zhí)行標(biāo)準(zhǔn)情況的實(shí)施結(jié)果。例如臺(tái)賬、操作記 錄、表示狀態(tài)的單、卡、牌等。3.2. Classification code of document 文件分類號(hào) 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文件按文件類別分為質(zhì)量、機(jī)構(gòu)與人員、廠房與設(shè)施、設(shè)備、物 料、確認(rèn)與驗(yàn)證、文件、生產(chǎn)、衛(wèi)生、委托生產(chǎn)與委托檢驗(yàn)、產(chǎn)品發(fā)運(yùn)與召 回、審計(jì)等12類。包括：管理標(biāo)準(zhǔn)、操作標(biāo)準(zhǔn)及其實(shí)施需要的記錄表格。 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. 各文件類別總分類號(hào)依次為01至12。按細(xì)分類文件類別對(duì)文件總分類進(jìn) 行細(xì)分類，細(xì)分類號(hào)依次為01、02、03o按部門或文件管理類別再進(jìn) 行細(xì)分類，細(xì)分類號(hào)依次為01、02、03。具體分類見(jiàn)下表：文件類別 Item總分類號(hào)Item code細(xì)分類文件類別 Section細(xì)分 類號(hào) Section code細(xì)分類文件類別Sub-section細(xì)分 類號(hào) Subsectio

16、n code質(zhì)量 Quality01總述Summary01質(zhì)量管理手冊(cè) Quality management handbook01質(zhì)量保證 Quality assurance02管理文件 Management file01質(zhì)量檢驗(yàn)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 在這里輸入公司名稱或有公司標(biāo)志Document name

17、:文檔名稱:文件的分類與編碼Taxonomy and code of documentsNumber / version:編號(hào) 1版本號(hào):07.01.01-002-00文件類別 Item總分類號(hào)Item code細(xì)分類文件類別 Section細(xì)分 類號(hào) Section code細(xì)分類文件類別 Sub-section細(xì)分 類號(hào) Subsection code質(zhì)量標(biāo)準(zhǔn) Specification04原料質(zhì)量標(biāo)準(zhǔn)0Specifications of API001輔料質(zhì)量標(biāo)準(zhǔn) Specification of excipients002包材質(zhì)量標(biāo)準(zhǔn) Specification of packaging

18、 materiel03中間產(chǎn)品質(zhì)量標(biāo)準(zhǔn) Specifications of intermediates04成品質(zhì)量標(biāo)準(zhǔn) Specification of finished products05介質(zhì)質(zhì)量標(biāo)準(zhǔn)Specifications of medias06檢驗(yàn)規(guī)程Analytical instruction05原料質(zhì)量標(biāo)準(zhǔn)Specifications of API01輔料質(zhì)量標(biāo)準(zhǔn) Specification of excipients02包材質(zhì)量標(biāo)準(zhǔn) Specification of packaging materiel03中間產(chǎn)品質(zhì)量標(biāo)準(zhǔn) Specifications of intermed

19、iates04成品質(zhì)量標(biāo)準(zhǔn) Specification of finished products05介質(zhì)質(zhì)量標(biāo)準(zhǔn) Specifications of medias06清洗殘留量檢驗(yàn)規(guī)程 Analytical instruction of cleaning residual amount07其它Others08檢驗(yàn)SOPQuality control SOP06取樣Sampling01環(huán)境監(jiān)測(cè) Environmental monitoring02標(biāo)定Standardization03穩(wěn)定性試驗(yàn)Stability test04oos05From here the Entering Firm nam

20、e or logo 在這里輸入公司名稱或有公司標(biāo)志Document name:文檔名稱:文件的分類與編碼Taxonomy and code of documentsNumber / version:編號(hào) 1版本號(hào):07.01.01-002-00文件類別 Item總分類號(hào)Item code細(xì)分類文件類別 Section細(xì)分 類號(hào) Section code細(xì)分類文件類別 Sub-section細(xì)分 類號(hào) Subsection code機(jī)構(gòu)與人員Organization and personnel02機(jī)構(gòu)、人員管理Organization and Personnel management0ISOP0

21、1部門職責(zé) Department responsibility02各部門職責(zé) Responsibility of each department01崗位職責(zé)Position responsibility03總經(jīng)理辦公室General manager01管理委員會(huì)Administration committees02QA/ QC 部QA/ QC department03生產(chǎn)技術(shù)部 Production & technology department04倉(cāng)庫(kù) Warehouse05設(shè)備工程部Equipment department06供應(yīng)部Supply department07開(kāi)發(fā)部R&a

22、mp;D department08行政Administration09財(cái)務(wù)Finance department10銷售部Sales departmentII口服固體制劑車間 Oral solid preparation workshop12注射劑車間Injection workshop13中試車間Pilot workshop14廠房與設(shè)施 Premises and facility03管理SOPManagement SOP01廠房、建筑管理Building and rooms management01房間手冊(cè)Room book02QA部 QA department01QC部QC departm

23、ent02倉(cāng)庫(kù) Warehouse03設(shè)備工程部Equipment department04開(kāi)發(fā)部R&D department05From here the Entering Firm name or logo 在這里輸入公司名稱或有公司標(biāo)志Document name:文檔名稱:文件的分類與編碼Taxonomy and code of documentsNumber / version:編號(hào) 1版本號(hào):07.01.01-002-00文件類別 Item總分類號(hào)Item code細(xì)分類文件類別 Section細(xì)分 類號(hào) Section code細(xì)分類文件類別 Sub-section細(xì)分 類

24、號(hào) Subsection code行政辦公樓 Administration office building06口服固體制劑車間 Oral solid preparation workshop07注射劑車間Injection workshop08設(shè)備Equipment04管理 Management01SOP01設(shè)備技術(shù)手冊(cè)Equipment technique manual02公共系統(tǒng)設(shè)備Equipment in public system01質(zhì)量控制儀器設(shè)備 Apparatus in quality control dept.02倉(cāng)庫(kù)Equipment in warehouse03水系統(tǒng)設(shè)備E

25、quipment in v/ater supply units04空調(diào)系統(tǒng)設(shè)備Equipment in HVAC-system05口服固體制劑車間 Oral solid preparation workshop06注射劑車間Injection workshop07中試車間 Pilot workshop08設(shè)備儀器校正 Calibration of equipment and apparatus03公共系統(tǒng)設(shè)備Equipment in public system01質(zhì)量控制儀器設(shè)備 Apparatus in quality control dept.02倉(cāng)在Equipment in wareho

26、use03水系統(tǒng)設(shè)備Equipment in water supply units04空調(diào)系統(tǒng)設(shè)備Equipment in HVAC-system05口服固體制劑車間 Oral solid preparation workshop06注射劑車間Injection workshop07From here the Entering Firm name or logo 在這里輸入公司名稱或有公司標(biāo)志Document name:文檔名稱:文件的分類與編碼Taxonomy and code of documentsNumber / version:編號(hào) 1版本號(hào):07.01.01-002-00文件類別

27、Item總分類號(hào)Item code細(xì)分類文件類別 Section細(xì)分 類號(hào) Section code細(xì)分類文件類別 Sub-section細(xì)分 類號(hào) Subsection code中試車間 Pilot workshop08設(shè)備維護(hù)、保養(yǎng) Maintenance04公共系統(tǒng)設(shè)備Equipment in public system01質(zhì)量控制儀器設(shè)備 Apparatus in quality control dept.02倉(cāng)庫(kù)Equipment in warehouse03水系統(tǒng)設(shè)備Equipment in water supply units04空調(diào)系統(tǒng)設(shè)備Equipment in HVAC-s

28、ystem05口服固體制劑車間 Oral solid preparation workshop06注射劑車間Injection workshop07中試車間Pilot workshop08物料Materials05SOP01倉(cāng)庫(kù)布局圖Layout of v/arehouse01倉(cāng)庫(kù)管理Warehouse management02物料管理Material management03確認(rèn)與驗(yàn)證Qualification and Validation06主計(jì)劃和管理SOPMaster plan and Management SOP0I主計(jì)劃Master plan01驗(yàn)證/確認(rèn)分計(jì)劃Sub-VMP an

29、d Sub-QMP02管理SOP Management SOP03房間Room02QA部 QA department01QC部QC department02倉(cāng)庫(kù) Warehouse03設(shè)備工程部Equipment department04開(kāi)發(fā)部R&D department05行政辦公樓 Administration office building06口服固體制劑車間 Oral solid preparation workshop07注射劑車間Injection workshop08中試車間Pilot workshop09設(shè)備和儀器Equipment and apparatus03公共系

30、統(tǒng)設(shè)備Equipment in public system01質(zhì)量檢驗(yàn)儀器設(shè)備02From here the Entering Firm name or logo 在這里輸入公司名稱或有公司標(biāo)志Document name:文檔名稱:文件的分類與編碼Taxonomy and code of documentsNumber / version:編號(hào) 1版本號(hào):07.01.01-002-00文件類別 Item總分類號(hào)Item code細(xì)分類文件類別 Section細(xì)分 類號(hào) Section code細(xì)分類文件類別 Sub-section細(xì)分 類號(hào) Subsection codeApparatus i

31、n quality control dept.口服固體制劑車間 Oral solid preparation workshop03注射劑車間設(shè)備 Injection workshop04倉(cāng)庫(kù)Equipment in warehouse05水系統(tǒng)Water system04純化水Purity water01注射用水Water for injection02QC純化水系統(tǒng)QC purity water03空調(diào)Air condition05口服固體制劑車間 Oral solid preparation workshop01注射劑車間Injection workshop02QC檢驗(yàn)QC test03取

32、樣室Sampling room04分析方法Analytical method06含量測(cè)定 Assay001有關(guān)物質(zhì)Related substance02殘留溶劑Residual solvents03微生物限度Microbial limit04無(wú)菌Sterility05內(nèi)毒素 Endotoxin06微生物Microbe07清洗殘留量 Cleaning residual amount08工藝 Process07口服固體制劑車間 Oral solid preparation workshop01注射劑車間Injection workshop02中試車間Pilot workshop02滅菌驗(yàn)證 Ste

33、rilization process validation08QC部QC department01口服固體制劑車間 Oral solid preparation workshop02From here the Entering Firm name or logo 在這里輸入公司名稱或有公司標(biāo)志Document name:文檔名稱:文件的分類與編碼Taxonomy and code of documentsNumber / version:編號(hào) 1版本號(hào):07.01.01-002-00文件類別 Item總分類號(hào)Item code細(xì)分類文件類別 Section細(xì)分 類號(hào) Section code細(xì)

34、分類文件類別 Sub-section細(xì)分 類號(hào) Subsection code注射劑車間Injection workshop03中試車間Pilot workshop04消毒工藝驗(yàn)證 Disinfection process validation09口服固體制劑車間 Oral solid preparation workshop01注射劑車間Injection workshop02中試車間Pilot workshop03清洗CleaningIO設(shè)備Equipment01API容器API Container02隔離器Isolator03工具Tool04其他Others11傳遞Transfer0I服

35、裝類Clothes02其他Others03文件Documents07管理 Management01SOP01格式Format02生產(chǎn) Manufacture08管理Management0ISOP01工藝規(guī)程 Manufacturing instruction02口服固體工藝規(guī)程Manufacturing instructions of Oral solid preparation01注射劑工藝規(guī)程 Manufacturing instructions of injection02車間SOPSOP in workshops03口服固體制劑車間 Oral solid preparation wor

36、kshop01注射劑車間Injection workshop02中試車間 Pilot workshop03衛(wèi)生Sanitation09管理Management01衛(wèi)生主文件HMP01質(zhì)量管理Quality management02人員Personnel01設(shè)備Equipment02From here the Entering Firm name or logo 在這里輸入公司名稱或有公司標(biāo)志Document name:文檔名稱:文件的分類與編碼Taxonomy and code of documentsNumber / version:編號(hào) 1版本號(hào):07.01.01-002-00文件類別 I

37、tem總分類號(hào)Item code細(xì)分類文件類別 Section細(xì)分 類號(hào) Section code細(xì)分類文件類別 Sub-section細(xì)分 類號(hào) Subsection code崗位Location03倉(cāng)庫(kù) Warehouse03人員Personnel01設(shè)備Equipment02崗位Location03設(shè)備工程部 Equipment engineering dept.04人員 Personnel01設(shè)備Equipment02崗位Location03口服固體制劑車間 Oral solid preparation workshop05人員Personnel01設(shè)備Equipment02崗位Loc

38、ation03注射劑車間Injection workshop06人員Personnel01設(shè)備Equipment02崗位Location03中試車間Pilot workshop07人員Personnel01設(shè)備Equipment02崗位Location03其它Others08人員 Personnel01設(shè)備Equipment02崗位Location03委托生產(chǎn)與委托檢Contract production and test10生產(chǎn) Production01委托生產(chǎn)Contract production01檢驗(yàn)Test02委托檢驗(yàn)Contract test01產(chǎn)品發(fā)運(yùn)與召回 Production

39、 delivery and recall11SOP01銷售管理Sale management0I投訴Complaints02召回 Recall03審計(jì)I201自檢0IFrom here the Entering Firm name or logo 在這里輸入公司名稱或有公司標(biāo)志Document name:文檔名稱:文件的分類與編碼Taxonomy and code of documentsNumber / version:編號(hào) 1版本號(hào):07.01.01-002-00文件類別 Item總分類號(hào)Item code細(xì)分類文件類別 Section細(xì)分 類號(hào) Section code細(xì)分類文件類別 S

40、ub-section細(xì)分 類號(hào) Subsection codeAuditSelf-inspection供應(yīng)商審計(jì)Supplier audit02接受審計(jì)檢查Audited procedure03委托生產(chǎn)、檢驗(yàn)弟位審計(jì) Contract production and test unit audit0. Definition of Code number system 文件的編碼 3.3.1 Code number system of standard documentation標(biāo)準(zhǔn)類文件編碼的格式 XX. XX. XX - XXXX X；/ I ! 總分類號(hào) 細(xì)分類號(hào)細(xì)分類號(hào) 文

41、件序列號(hào)版本號(hào) 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. 總分類號(hào)：公司文件按GMP各管理內(nèi)容分類，總分類號(hào)依次為01、 02、12o Section or subsection: Documentation is subdivided Into section and subsection and the codes possess numbers beginning with 01, 02, 03 細(xì)分類號(hào)：需要對(duì)文件進(jìn)行細(xì)分類的號(hào)，依次為01、02、03。 Sequence number of documentation beginning with Arabic numerals 001. 文件序列號(hào)：用阿拉伯?dāng)?shù)字001依順序三位數(shù)開(kāi)始編排下去。 Version number: Expressed by Arabic numerals such as