MSD Document Control Training

1、Document Control Training for China, New MSD Facility Hangzhou ( Project Number:10039475 )PDCCProject Document Control CenterContentDocument NameDocument NumberVersionDocument control procedureBPC-10039475-GD-PCD-0012.0Document numbering systemBPC-10039475-GD-PCD-0022.0Document Control ProcedureDocu

2、ment No.:BPC-10039745-GD-PCD-001Document control procedureScopeGeneralControl of documentsStorage and archiveControl and distribution of approved documents/drawingsDocument handoverScopeThis document control procedure covers:The creation, review, approval, filing, retention, revision of all MSD prod

3、uced technical documents (e.g.URS, Procedures, Validation documents ,etc.).Managing receipt, distribution, filing and retention of vendor, contractor and/or other 3rd party technical documents .This document control procedure doesnt cover:Finance/Commercial document (e.g. Tender document, Bid docume

4、nt, Purchase order, Cost control, etc.) All SOPs (e.g. equipment operation/maintenance SOPs)GeneralProject languageIn General, documents should be written in EnglishThe protocols & reports of Qualification and Validation should be bilingual (English & Chinese), the language for personnel to fill in

5、the Qualification and Validation report prefers Chinese.For special documents which need to be bilingual or only in Chinese, can be decided by MSD site QA case by case.Signature ruleAll signatures of project members should be registered in the signature record.Control of documentsMSD produced docume

6、ntsVendor/3rd party produced documentsQualification& Validation Protocols and ReportsMSD produced documentsCreation, Review, Approval of MSD produced documentsRevision of MSD produced documentsSimilar as above, the detail please read procedure by yourselfThe writer : Based on recommended document te

7、mplateThe writer : After approval, the effective date shall be hand written on the document , the effective date is the last approval date.The writer is responsible for sending the electronic document & handingoriginal approved document to PDCC for archiving. PDC will update the relevant list accord

8、ingly& upload it to teamsite.Reviewer should return their comments to the writer (suggested within 5 working days).Vendor/3rd party produced documentsThis section only applies to technical documents/drawings received from Vendor/3rd parties, which requires to be reviewed and/or approved by relevant

9、functional groups in MSD during project phase.The other documents of Vendor/3rd party will be managed according to their respective document procedure and are not covered in this section.Vendor/3rd party produced documentsReview, Approval, and Revision of Vendor/3rd party produced documentsThe relev

10、ant functional group in MSD is responsible for noticing vendor/3rd party to scan the approved document/drawing & send it to PDCC, PDCC will upload document/drawing to team site of project folder, If the drawing is difficult to scan, it is acceptable to give an electronic drawing plus a scannedsignat

11、ure part.Qualification& Validation Protocols and ReportsQualification & Validation Protocols and Reports shall be created, reviewed, approved, revision and controlled in accordance with the current procedure of Hangzhou MSD Pharmaceutical Co.,Ltd.(Q1046 GMP SLC General Procedure)Storage and archive

12、PQ/PV documents will be archived by Hangzhou Pharmaceutical Co.,Ltd also are not covered as blow:Electronic documents (only Pdf)For the documents produced by MSD, after approval, the electronic documents will be uploaded by PDC to MSD intranet, “team site” of project folder until ready for handover.

13、Original Paper documents & Drawings PDCC is responsible for filling all approved signed document (from Design document) in the project archive, which shall be a secure lockable location. Control and distribution of approved documents/drawingsDistribution & control of approved documentsUse of documen

14、ts &drawings for GEP&GMP activitiesDocument check in and check outSuperseded documentsReplaced documentsCancelled documentsControl and distribution of approved documents/drawingsDistribution & control of approved documentsAll approved documents & drawings will be distributed in electronic form to MS

15、D intranet, “team site” of project folder.All original approved documents & drawings in paper form will be archived in the project archive by PDCC.Use of documents &drawings for GEP&GMP activitiesWhere documents and / or drawings are used for GEP and / or GMP activities (e.g. walk downs, verificatio

16、ns etc.), a working copy of the current approved document/drawing should be requested via PDCC, PDCC will copy the document/drawing and stamp WORKING COPY on it.PDCC is to maintain a log of controlled copies to enable document traceabilityControl and distribution of approved documents/drawingsDocume

17、nt check in and check out Personnel who remove document (s) from the PDCC MUST complete the sign out log and upon return complete the sign in log. Documents removed from PDCC are to be returned within 10 working days. Personnel can come to PDCC to return the document and re-borrow it if he/she finds

18、 10 working days is not enough.Superseded documents Controlled by Project Document ControllerReplaced documentsControlled by Project Document ControllerCancelled documentsControlled by Project Document ControllerDocument handoverVendor/3rd party handover their documents to PDCCPDCC will accept Vendo

19、r/3rd partys documents according to a detailed Vendor handover list which was agreed by MSD. A Merck employee should verify those documents during handover. Usually the handover will be performed system by system.PDCC handover to MSD Hangzhou siteDocuments generated during the execution of the proje

20、ct will be handed over to site either during or at the completion of the project.PDCC shall deliver original signed off documents to site QA and electronic copy is supplemented according to the deliver list.Document Numbering SystemDocument number:BPC-10039745-GD-PCD-002Document Numbering SystemScop

21、eStructure for document numbering numberVersion controlApproved document before this procedure come into effectScopeThis document numbering system covers:The document numbering control of technical documents of China New MSD Facility Project.This document control procedure doesnt cover:Finance/Comme

22、rcial document (e.g. Tender document, Bid document, Purchase order, Cost control, etc.) All SOPs (e.g. equipment operation/maintenance SOPs)Structure for document numbering numberNumbering of technical documents produced by MSD.Numbering of Vendor/3rd party produced documentsDrawing numberingNumberi

23、ng of technical documents produced by MSDNumber structurePlant Identity Abbreviation Document Type 10039475System Number/ System CategorySequence NumberProject NumberNumber structure-continuePlant Identity AbbreviationPKGPackaging Operation Facility COMCommercialization FacilityBPCBoth Packaging Ope

24、ration Facility & Commercialization FacilityProject Number:Project number is 10039475.Number structure-continueSystem Number or System CategorySystem NumberSystem Number refers to MSD System List for Packaging Operation Facility and MSD System List for Commercialization Facility. To avoid confusion,

25、 if System Number includes symbol of “, the “” of System Number have to adjust into symbol of “:” . System Category If one document covers several systems, will use system category for this naming section, system categories are as blow:GDGeneral DocumentAMAutomation systemPEProcess equipment LBLab e

26、quipmentHAHVACMBMechanical Black UtilityMCMechanical Clean UtilityELElectrical SystemEHSEnvironment Health & Safety* * * Other system categories which can be added by PDCCNumber structure-continueDocument typesCHRChange RequirementCAS-Calculation SheetCLAComponent Level AssessmentCQPCommissioning &Q

27、ualification PlanCMPConfiguration Management PlanGDLGuidelineHDPHandover PlanLST ListPLNPlanPCDProcedurePRSPurchase Requirement Specification QAPQuality Assurance PlanAQAPAutomation Quality Assurance PlanQASRAutomation Quality Assurance Summary ReportRTMRequirement Traceability MatrixSIASystem Impac

28、t AssessmentSPCSpecificationTEMTemplateURSUser Requirement SpecificationVDRVendor Document RequirementWOIWork Instruction VMPValidation Master PlanNumber structure-continueDocument typesVMRValidation Master ReportDQ- Design Qualification Protocol/ReportFAT- Factory Acceptance Test Plan/ReportSAT- Si

29、te Acceptance Test Plan/ReportIC - Installation Commissioning Plan/ReportOC- Operational Commissioning Plan/Report IQ - Installation Qualification Protocol/ReportOQ- Operational Qualification Protocol/ReportIOQCombined Installation & Operational Qualification Protocol/ReportPQP- Performance Qualific

30、ation ProtocolPQR- Performance Qualification ReportPQ- Performance Qualification Protocol/ReportPVPProcess Validation ProtocolPVRProcess Validation ReportCLVCleaning Validation ProtocolCLRCleaning Validation ReportAMPAnalysis Method Validation ProtocolAMRAnalysis Method Validation ReportCALCalibrati

31、onOTHOthers* * * Other document types which can be added by PDCC(FS.)Number structure-continueSequence NumberSequence number is different from version number, sequence number is used to distinguish the documents which have the same plant identity, system number/system category, document type.Three c

32、haracters express for Sequence Number: start from 001Numbering of Vendor/3rd party produced documentsDocument number for vendor/3rd party shall be defined within the respective vendor quality plan and/or procedureFor the commissioning Plan/Protocol/Report, besides Vendor/Contractors document number,

33、 will be added MSD document number.Drawing numbering Drawing numbering for Vendor/Contractors and other 3rd Parties shall be defined within the respective Vendor/Contractor Quality Plan and/or Procedure.VERSION CONTROLDocument Status Version Explanation Draft 0.00.10.2etc The draft/working version s

34、tarts at 0.0, then become 0.1, 0.2 etc. When the last draft/working version of document is ready to come into effect, the version number will be updated to 1.0.First version in effect 1.0The version number of first approved documentDraft of changes to first version in effect 1.11.21.3etc The first d

35、raft/working version of changes to a version 1.0 is assigned the version number 1.1.Changes are made to version 1.1, subsequent draft/working version are numbered 1.2,1.3,etc. Second version in effect 2.0The version number of Second approved document etc. 2.12.2etc. VERSION CONTROLAll integer versio

36、n（i.e. effective version）of the document must be filed during project phase. As long as one and the same person is working on a document and it has not yet been distributed to anybody else, the document can keep the same draft/working version and it can be overwritten several times.After distributio

37、n of a document, revising the document is not allowed without changing the documents version.Approved document before this procedure come into effectFor the approved documents before this procedure come into effect, the document number will be adjusted when the document updates. Transmittal & Submit

38、tal General During the project execution phase when MSD project member received docs & drawingsfrom external organisation,PDC is responsible for register all of them in the Transmittal Log, besides when MSD need give feedback PDC need register them in the Submittal Log . As well as MSD send out docu

39、ments ,the Originator should prepare the Transmittal Sheet meanwhile scan and upload it to teamsite, then PDC will register it in the Transmittal Log Out .Note : The logs and Transmittal sheet template are filed in new project system Folder 09.0 Construction .PracticeExample 1: Document generate and

40、 archive steps.An engineer is going to write a URS for Autoclave of Packing Operation Facility, how will he/she follow the procedure?Example 1- ContinueStep 1: To contact PDCC to get a document number; At the same time, to offer PDCC the relevant information, e.g. Which plant dose this document cove

41、r, which systems does this document cover.Step 2: After get a document number and format (currently only word document has a format), to start review/approval progress.Step 3: After document approved, author is responsible for sending the electronic document & handing original approved document to PDCC for archiving. Step 4: PDCC will update the relevant list accordingly. Example 2: Document numberingThe document number for URS of autoclave of Packing Operation Facilit