CGMP文件文件印制、分发、保管、收回、销毁、撤销SOP

1、 文件题目Document Title文件印制、发放、保管、收回、销毁SOPSOP - Printing, delivery, filing, recalling and destruction of 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

2、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 Aim 建立GMP文件的复制、

3、分发、保管、收回、销毁、撤销程序，使文件保管和使用规范化。The purpose of this SOP is to define an appropriate procedure for the printing, delivery, keeping, recalling, destruction and revocation of documents, in order to standardize keeping and using of documents.2. 范围 Scope 所有GMP文件的复制、分发、保管、收回、销毁、撤销管理过程。The SOP must be applied

4、 to the printing, delivery, keeping, recalling, destruction and revocation of all the GMP-related documents at Huiyu.3. SOP的内容 Content of Standard Operating Procedure3.1 复印/分发/收回 Printing/delivery/recalling公司GMP文件由QA部进行管理，任何部门不得私自复印。若发生以下情况需要使用文件的复印件，须由使用部门填写文件复印申请表（见附录1）向QA部提出申请，由QA负责人批准，交付文件管理QA进行

5、复印、分发。GMP documents are managed by QA department, and no another department shall copy without permission. In case of the following condition to copy the documents, the use department s apply to QA department by filling out the "Application for Document Copy "(see Annex 1). After approving

6、 by the head of QA, the application should be delivered to document manage QA for document copying and distribution.3.1.1 新编文件复印、分发 Copying and distribution of new documents 新编文件生效后，由文件管理QA根据根据文件首页所示的发放部门确定需复印的份数，并亲自负责复印。复印件应能清晰可辨，复印过程中作废的文件应即时销毁。复印结束后必需在原件及复印文件的每一页上加印“GMP批准文件”。Document manage QA mu

7、st define how many copies has to be printed off according to the number of related-departments described in the first page of the document, and copy the document personally after the document take into force. Copies must be clear and distinguishable and the obsolete paper should be destroyed immedia

8、tely. The copies and the original document must be stamped “Approved GMP document” on each page. 文件管理QA逐部门到现场发放复印并盖章的新编文件。发放新编文件同时，文件发放和接收人应完成文件控制单（见附录2）。Document manage QA must deliver newly updated stamped document copies to each department personally .At the same time, both document suppliers and

9、 receivers should accomplish “Document Control Records “(see Annex 2).所有文件控制单应按文件编号分类保存于QA部文件资料室，在后续的文件管理程序中亦将使用此单。All “Document Control Records “should be classified by documents numbers and stored in the QA document room, it will also be used in the follow-up document management procedures.3.1.2 修

10、订文件的复印、发放、收回 Printing ,delivery and calling of revised documents经过变更控制SOP（编码： ）程序修订的文件，确定生效后，应由文件管理QA使用原件根根据文件首页所示的发放部门进行复印，复印件应能清晰可辨，复印过程中作废的文件应即时销毁。复印结束后必需在原件及复印文件的每一页上加印“GMP批准文件”。Revised documents on the basis of the procedure " SOP - Change control Procedures"(code: ), if once determin

11、ed to the entry into force, shall be printed out by document manage QA according to the receiving departments on the first page of the original document, and copies should be legible, the obsoleted papers in the process of copying should be destroyed immediately. After copying, its necessary to stam

12、p "GMP approval documents" on and each page of originals and copies.文件管理QA根据上一版本的文件控制单（见附录2）到各部门将现场使用的旧版本文件收回，领、发双方应办理文件交接手续，填写文件控制单，对收回的原有文件，应核实收回文件名称、数量是否与原文件发放登记记录相符。如有不符或遗失应由文件管理员和当事人双方共同查明不符或遗失原因，并在文件控制单的备注中进行登记。Recall the previous version of the documents according to “Document Contr

13、ol Records “(see annex 2)of last version, Receiver and suppliers have to transact document handover procedures, fill the “Document Control Records “, and check the name and quantity of documents to see to that recalled original match with original document delivery records. If it does not comply wit

14、h delivery record or there is loss, the document manages QA and the related person must investigate the reason and recorded at remarks of “Document Control Records “.收回的文件应包括现场文件、岗位张贴文件、培训文件以及空白记录。外发文件因无法收回，故不包括在内。确认丢失的文件亦不在收回之列。均应在文件控制单中备注清楚。The recalled documents should include on-site documents,

15、post posted documents, training documents and blank records. Documents could not be recovered because of Dispatch of the document, so it is not included. Confirmatively Lost documents are also out of list. It should be noted clearly in the "Document Controlled record" .文件管理QA收回旧版本文件后，将新版本文

16、件按文件第一页的发放部门进行发放。领、发双方应办理文件交接手续，填写该文件编号对应的新的文件控制单。新的文件控制单应替换旧的文件控制单，旧版本的文件控制单则作为部门管理记录保存于QA部文件资料室。After recalling the older version documents, document manage QA deliver the new version ones according to delivering department on the first page. Receiver and suppliers have to transact document handov

17、er procedures, fill the "Document Controlled record" corresponding to the document codes. New "Document Controlled record" replaces old ones. Old version "Document Controlled record" is stored as a department management document in the QA document room.3.1.3 岗位张贴文件复印、发放

18、 Printing and delivery of Post posted documents部门岗位张贴类文件划分，车间，需张贴设备技术手册、设备清洗SOP，岗位清场SOP和岗位操作SOP；QC部需张贴技术手册，仓库需张贴物料SOP，设备部需张贴技术手册和维护保养SOP。The department post posted documents classify to: The equipment in workshop, must post the equipment technical manual, the equipment cleaning SOP, the post cleanin

19、g SOP and the post operation SOP; QC must post the technical manual; The warehouse must post material SOP; The equipment department must post the technical manual and the maintenance SOP. 由文件使用部门填写文件复印申请表（见附录1）向QA部提出申请，经QA负责人批准，交付文件管理QA进行使用文件原件进行复印。并于复印件的第一页上加盖“岗位文件”章，签署复印理由以及总页数。发放时，发、领双方在文件控制单（见附录

20、2）上进行登记，并注明发放原因。The departments using documents should fill out the "Application for Document Copy"(see annex 1) to QA department, after the head of QA approves and deliver to document manage QA uses the original documents for copying. On the first page of copy stamp the "Post Documen

21、t" seals, sign in the reasons to copy and the total number of pages. When delivering, receiver and suppliers should register in in the "Document Control records"(see annex 2) and indicate the reason of delivery.3.1.4 培训文件复印、发放 Copying and delivering of training documents由培训组向填写文件复印申请表

22、（见附录1）向QA部提出申请，经QA负责人批准，交付文件管理QA进行使用文件原件进行复印。文件管理QA在复印件每一页上盖上“仅供培训”印章后发放给培训管理员，并在对应的文件控制单（见附录2）进行登记，注明发放原因。The training group fills out the "Application for Document Copy "(see annex1) to QA department, after the head of QA approves and deliver to document manage QA uses the original docum

23、ents for copying. On the first page of copy stamp the "only for training" seals, then deliver it to training administers, register in in the "Document Control records"(see annex 2) and indicate the reason of delivery.培训管理员收到培训文件后按员工培训、考核管理SOP（编码： ）中的规定将培训文件发放给各部门，供现场培训使用。After re

24、ceiving training documents, training administers deliver it to all departments to for on-site training according to “SOP -Training and examination of employees” (Code: ).培训结束之后，各部门将培训资料与培训文件交回给培训组保存，供新员工培训或定期培训使用。After training, all training materials and training documents will be returned to the t

25、raining group for saving, they can be used for new staff training or regular training.3.1.5 补发文件的复印、发放 Copying and delivering of reissue documents当出现以下情况，应由相关部门填写文件复印申请表（见附录1）向QA部提出申请，经QA负责人批准，交付文件管理QA进行使用文件原件进行复印、补发。复印后应在复印件的每一页盖上“增发文件”、“补发文件”或“外发文件”章，并在对应的文件控制单（见附录2）进行登记。In the following condition

26、s, relevant departments should fill out the "Application for Document Copy "(see annex1) to QA department, after the head of QA approves and deliver to document manage QA uses the original documents for copying and reissue. Each page of the copy must be stamped “Increase Document”, “Reissu

27、e Document” or “Dispatch Document”. And should register in "Document Control sheets "(see annex 2) 3.1.5.1 增加文件发放部门 Increasing document release department 某部门（车间）原不在发放范围内，现因工作需要某文件时，由使用部门可填写文件复印申请表，经本部门负责人和QA负责人批准后，到文件管理QA处办理增发手续，并在对应的文件控制单（见附录2）中注明增发。A department (workshop) is originally

28、not within delivery ,but now needs some document because of job demand, this department can fill out the " Application for Document Copy ", after approved by department head and head of QA, transact increasing procedures at document manage QA, and indicate in the original document " D

29、ocument Control sheets ".3.1.5.2 文件损坏 Document Damage当文件破损影响使用时，应填写文件复印申请表，并在申请理由处填写损坏原因，经本部门负责人和QA负责人批准后，到文件管理QA处办理更新手续，交回破损文件，补领新文件。文件管理QA将破损文件销毁，并在原文件文件控制单备注记录破损。When the document is damaged and affecting usage, related department should fill out the "Application for Document Copy "

30、;, and fill in causes of damage at the application blanks, after the approval of the department heads and head of QA, transact updating procedures at document manage QA, return the damaged document and receive the replacing document. Document manage QA must destroy the damaged document, and recorded

31、 damage in the original document "Document Control Sheets ".3.1.5.3 文件丢失 Document lost当受控文件使用人确信将文件丢失时，应填写文件复印申请表（见附录1），并在申请理由处填写丢失原因，经本部门负责人和QA负责人批准后，到文件管理QA处办理重新发放手续，并在对应的文件控制单中注明丢失。When users of controlled document assure controlled documents is lost, he/she should fill out the " A

32、pplication for Document Copy ", and fill in causes of lost at the application reason blank, after the approval of the department heads and QA manager, transact re-issuance procedure at Document manage QA and recorded lost in the original document "Document Control Sheets ".朗读3.1.6 外发文

33、件复印、发放 Copying and delivering of dispatch documents有外发文件需求的公司内某一部门，须填写文件复印申请表（见附录1）经部门负责人和QA负责人批准，到文件管理QA处办理外发手续。文件管理员将文件复印件加盖“保密文件章”，与受控文件收据（见附录3）一起交申请部门，并填写文件控制单。Some department which requires document dispatch should firstly fill in "Application for Document Copy ", communicate with doc

34、ument administrator of QA department and follow document reissue procedure after approved by Dept. supervisor and head of QA. Document administrator of QA should hand over the duplicate of the document and “Receipt of Controlled Document” to application department, meanwhile fulfills “Document Contr

35、ol Record”. 该申请部门将文件复印件与受控文件收据（见附录3）一起发给外发单位，外发单位收到后，在受控文件收据上签字，并返回QA保存。Application department send the copy of the document dispatched together with “Receipt of Controlled Document”, and the receiving unit signs on “Receipt of Controlled Document” which shall be returned back to QA department and s

36、aved.受控文件收据应作为部门管理记录由QA文件资料室保存。“Receipt of Controlled Document” should be saved together with the document dispatched.注意事项： Notice:文件控制单（见附录2）的发放部门编号，应在每一份复印件的第一页“文件发放部门”处填写。编号方式如下：原件设定分发“n”个部门，则第一个发放部门为“1/n”, 第二个发放部门为“2/n”，如果依此类推。例如：文件共分发9个部门，第一个部门为QA部，则QA部的复印文件第一页应为“1/9”。Delivery departments numbe

37、rs in "Document Control Sheets "(see annex 2), should be written in the " Department of document distributed:" on the first page of each copy. Number as below: Set "n" departments to receive Original documents, so the first delivery department is "1 / n", the

38、second one is "2 / n", and so on. For example: The file is delivered to nine departments, the first one is the QA department, the first page of the QA department's copy should be "1 / 9”.当增发、补发及外发文件时，发放编号不在原件上体现，但在文件控制单上应有记录。其编号应按此规则编制：增加一份文件，其编号则为“n+1/n”，增加第二份文件，其编号则为“n+2/n”，依此类推

39、。When there is increasing, replacing and dispatching documents, the release number is not reflected on the original document, but the "Document Control Sheets" must have the proper record. The number should be the preparation of this rule: one document increasing, its number is "n +1

40、/ n", if adding the second one, the release number should be "n +2 / n", and so on.每一份复印文件的发放编号，应在复印后由文件管理QA手写在该对应的复印件的第一页“文件分发部门”括号中，在文件发放、收回时，交接双方应对此编号进行复核确认。双交接The release number of each document must be hand written in the bracket after “Department of document distributed:” on the

41、 corresponding copys first page after copied by document manage QA. The releaser and receiver should double check this number when handing over the document.3.2 保管 Saving3.2.1 QA部 QA departmentQA部必须设文件管理QA，由专人负责管理文件。文件管理QA负责质量体系文件具体管理工作。检查文件是否到位及文件的执行情况是QA管理人员及各部门管理人员的共同职责，此项工作可通过日常检查和自检来进行。There sh

42、ould be specially-assigned document manage QA in QA department responsible for management of document. The document manage QA is responsible for concrete management of quality system document. QA inspector and other departments administers are responsible for checking whether documents in place and

43、implementation is satisfactory by routine inspection and self inspection.文件管理QA于文件控制单（见附录2）登记后，将文件原件及其文件控制单及相关文件管理记录按类归档上锁，只有经过授权的人才能处理。若为替代文件，将旧版取出，于每一页文件右上角加盖“作废”印章，封存于QA部。这些失效的文件单独放在一个柜子里，与有效的文件，完全隔离，避免与现行版本混淆使用。这些失效的文件在官员检查或是产品投诉的时候可能会用得上。After document manage QA filled in “Document Controlled S

44、heets”（see annex 2）, file and lock the original document ,its document controlled sheet and related document management records. Finally, these documents must be accessible only for authorised persons. Concerning the amended documents, take out the former edition and stamp“cancellation”on the top ri

45、ght corner, seal up for keeping in QA dept. one of the non - valid documents must be filed in an separated tank (filed them separately from the valid GMP documents). This non - valid version might be necessary or useful at inspections or events like product complaints.QA部负责确认/验证方案及报告的审核和保管，确认/验证方案及报

46、告应尽量装订成册，集中管理。QA Department is responsible for checking and saving the validation / validation plan and report. The validation/validation plan and report should be bound, and centralized management.QA部负责对供应商资料、审计报告、年度产品回顾资料等本部门的管理资料进行保管及审核，并对本部门的管理记录进行保管。QA department is responsible for checking and

47、 saving the suppliers data, audit reports, annual product review and the management data of department. QA department is also responsible for saving of the management records.QA部负责对外来文件进行管理。对于外来文件，QA部收到并做登记后，根据文件内容确定发放范围进行复印发放，并进行登记。外来文件原件保存在QA部。Where foreign documents involved, quality department s

48、hould receive and register them, then determine dispensed scope and dispense exact copies. The original copy of foreign document should be saved in QA department.3.2.2 各部门 Deparments各部门负责对本部门的现场文件进行保管和维护。各部门所使用的现场文件，必须是由QA部分发的有效版本的、印有“GMP批准文件”红章的文件。如是增发、补发文件则该“GMP批准文件”章为黑色复印章，并应每一页上同时有“增发文件”或“补发文件“红

49、章。The departments are responsible for the saving and maintenance of site document. The site documents used by departments must be the valid version printed with "GMP approval document" red stamp released by QA department. If it is increase or reissue document, the "GMP approval docume

50、nt" should be black copy, and there must be “Increase Document” or “Reissue Document” red stamp on each page at the same time.现场文件应用适当的文件夹进行整理后，按要求妥善保存于相应的房间，不得随意复印、借阅、涂改和损坏。不得在工作现场出现非许可复印文件、旧版文件。Site documents should be appropriate saved in corresponding room after clear up with appropriate fo

51、lder and not to copy, borrow, alter and damage. Non-valid copy, old version copy of document must not appear in operation location.各部门岗位张贴类文件，必须是GMP原件有效版本的复印件，印有“岗位文件”红章并写明复印用途的文件。The department post posts must be the copy of original GMP document with “Post Document” red stamp and use.岗位张贴类文件必须放置于相

52、应的岗位，供岗位人员使用。如在洁净区内，应进行过塑处理，避免产尘。The department post posts must be located in corresponding post for the using of post operators. If it is located in clean area, it should be over plastic to avoid produce dust.文件持有人应做好文件维护工作，保持文件的完好、无损，积极配合文件管理QA做好文件发放、收回工作。当人员调岗或调离、办理相关手续时，应向文件管理员交清有关文件，文件管理员应仔细核对文

53、件内容、数量并签署意见后，厂办才能办理调岗或调离厂手续。对于遗失文件者，必须阐明原因，追查到底，严格防止文件外泄。Document holders should keep documents in good condition and actively cooperate with document manage QA to distribute and recall documents. When employee changing post or leaving, they must send back the related documents to file manager. File

54、 manager must check the contents and quantity of the documentations then sign his / her statement. Then the office can transact related procedure. If it does not comply with delivery record or there is loss, file manager and the person concerned must investigate the reason and record in losing and d

55、efective documents register form.各部门需建立文件和记录的清单，便于管理。A list of documents and records should be established by related department for convenience for management.文件不得随意向与执行和管理文件无关的人员借阅。如确需借阅已归档文件，应由文件发放部门向外借阅,借阅人需及时填写文件借阅申请书（见附录4），并做到纸质版文件不得复印，文件管理QA应按期催还，以防止文件丢失或损坏。电子版文件严格做好保密工作。The borrower should f

56、ill the sheet of "Application of Document Borrowing"(Annex 4)if the borrowed document have been filed.Document should not be copied and must be returned at the the same day, document manage QA should urge to return the document. The electronic version of document should not be leaked out.3.3 文件销毁 Destroying of document3.3.1 对于超过保存期的文件，由文件管理QA填写文件销毁申请表（见附录5）经QA部经理及主管领导批准后由文件管理QA在其它QA的监督下销毁，销毁后应完成文件控制单（见附录2）中的销毁记录。If there are some documents that have exceeded their retention period, the document manage QA must fill in Application for Destructi