Product Process Mapping

Product Process Mapping

Methods:Quality Modules and Relevant Local SOPsForecasts/Receiving orders from CustomerSUPPLY CHAINWAREHOUSEMANUFACTURINGQUALITY CONTROLMS & TSTAGING WAREHOUSEENGINEERINGMaterial arrival at the Warehouse(ZAIS-SOP-00826)Inspection 1:- PO and Vendor Verification- Complete (ZAIS-FRM-01268)Inspection Passed?YesNoUnload TruckPlace in Reception AreaInspection Passed?Reject RM and label with “Redsticker. Store in Reject Store(Imports: Reject and alert Purchasing/Supplier)(ZAIS-SOP-01890)NoObtain GRN and LabelsSample (ZAIS-SOP-00057)(send to QC for testing)Ready to IssueApproved?YesReturn to SupplierInspection 2:Quantities and Batch no. VerificationWrite Off(ZAIS-SOP-00210)NoMove RM to DispensaryTRANSFERS:Technological Transfer (ZAIS-SOP-00975)Analytical Method Transfer (ZAIS-SOP-01077)VALIDATION:Process Validation (ZAIS-SOP-00026)Cleaning Validation(ZAIS-SOP-00025)Ongoing Process Verification(ZAIS-SOP-01738)DISPENSARYTest Method:Analytical Method Validation (ZAIS-SOP-00720)Tech Transfer Protocol,Method Transfer Protocol Validation Protocols and Reports,Risk Assessment ReportAnalytical Method Protocol / ReportHSELocal / ImportsImportsLocalCONTROL CENTRE : Samples receipt and Admin(ZAIS-SOP-00343)Testing Methods:Results Comply?OOS Investigation (ZAIS-SOP-SOP 0042)Check/ Review DocumentationEquipment Ready?EQUIPMENT :Qualification MaintenanceCalibrationOperationDaily VerificationsYesNoNoYesInvestigation ReportRetest / Reject / Pass?Equipment log-books fulfilled Results and References in Laboratory Worksheet (ZAIS-SOP-SOP 0000) Note book and Raw data print-outs ReviewPrint-outs, ChromatogramsRelease(ZAIS-SOP-01797)RejectRetestRejectRetestLine Clearance, Opening and Closing(ZAIS-SOP-01729)PreparationProcessGranulationCompression / EncapsulationCoatingCleaningEquipment CleaningRoom Cleaning(ZAIS-SOP-00409)Fill Batch RecordFill Log booksFill Log booksFill Log booksPACKAGINGLine ClearancePreparationLine OpeningPackingPrimary(Securitaners / Blisters)Secondary(Labelling / Coding)Tertiary(Shippers/Palletising / Wrapping)(ZAIS-SOP-01486)In-Process Control (ZAIS-SOP-00602)CleaningCleaning of Packaging Area (ZAIS-SOP-00912)Fill Master Packaging InstructionFill Log booksFill Log booksFill Log booksDaily Balance Verification(00253)Fill Log booksLabellingFilling MMITesting, QC and QA ApprovalDistributionUTI(ZAIS-SOP-SOP 00267)(Bulk Manufacturing ZAIS-SOP-00465)(Bulk Packaging ZAIS-SOP-00693)Gowning(ZAIS-SOP-00349)P/Line Close Down(ZAIS-SOP-00322)Fill Status LabelPrepare for DistributionGowning(00349)Dispensing(00566)Cleaning(00384)Fill Log bookMicrobial Lab:Environmental Testing(ZAIS-SOP-00269)Purified Water Testing (ZAIS-SOP-00231)Stability Lab:Stability SOP (ZAIS-SOP-00148)Media Preparation (ZAIS-SOP-00247)Product Testing(ZAIS-SOP-00306)StorePlant Maintenance (ZAIS-SOP-PPM)(ZAIS-SOP-00819)Allocate Work Order to TechnicianObtain/Print Work Orders from SAPPerform Work Order ActivitiesReview Work OrdersLog/Capture on SAP SystemPass / FailLog to SAP SystemYesSystem ReadyNoPass Biovac Hexaxim Process Flow - Data IntegrityStartEndIPC (00280)IPC (00280)IPC (00280)YesQualification (00201)Equipment list(Specific)Projects (00839)Plant Maintenance (00827)Instrument Calibration (00732) UTILITIES HVAC (00868)Compressed Air (01059)Purified Water (00819)Goods Receiving NoteStorage(ZAIS-SOP-00823)Gowning(ZAIS-SOP-00349)ITIGM Manual V2.0Inventories and Classification: (IGM.SDZ.001_V2)Main Document and Acceptance: (IGM.SDZ.000_V02)IT Organization Definition: (IGM.DSM 007)IT SECURITY: (IGM.DSM 008 V02)IT Continuity, Disaster Recovery & Backup Management: (IGM.STD 009.v01)IT Operations: (IGM.DSM 005 V02)Incident Management Process Flow: (IGM.DSM 005 V02 A01)Change Management Process Flow: (IGM.DSM 005 V02 A02)Data Center Access Management Process Flow: (IGM.DSM 005 V02 A04)User Access Management Process Flow: (IGM.DSM 005 V02 A03)IT Project Management: (IGM SDZ 004_V02)Information Management: (IGM.DSM 010 V02)Service Provider Management: (IGM.DSM 009 V02)Method Validation (ZAIS-SOP-00720)Quality Control Testing and Usage Decision(ZAIS-SOP-00590)OOS (ZAIS-SOP-00289)Operating PlanPurchasing(SOP-01497)Scheduling (ZAIS-SOP-01813)Support StructuresSUPPORT STRUCTURES / SYSTEMSImported BulkCLINICEmployee Health Medicals(ZAIS-MAN-01218)(01209, 00966)PEST CONTROL (ZAIS-SOP-00902)HSE(ZAIS-SOP-01713)WASTE MANAGEMENT(ZAIS-SOP-00471)07. Analytics and Testing(01077), (00590), (00265), (00287)06. Commercial Manufacturing ‎(00201), (01716), (00011), (00819), (01792), (01788), (01852), (00026), (01738), (00025), (00464), (01554)05. Technical Development and Tech Transfer(00975)03. Quality and Compliance Systems(00043), (00002), (00174), (00177), (00353), (00042), (00842), (01092), (00054), (0057), (00148), (00034), (00823), (00267), (00979), (01081), (00827), (00896)02. Management Responsibility(00437), (01413), (01848), (01487), (01760), (01392), (00826), (00143)01. Corporate Quality Organization(00372), (01171)QUALITY ASSURANCESITE QUALITY PLAN (ZAIS-SOP-01772)Site Quality Risk AssessmentSite Quality Plan Management ReviewSUPPLIER MANAGEMENTSupplier Approval, Qualification for Reduced Testing and Monitoring including TSE Requirements (ZAIS-SOP-00143)Management of 3rd Party and Outsourced Activities (ZAIS-SOP-01395)Quality Agreement for Contract Manufacture, Packaging, Distribution and Analysis (ZAIS-SOP-00170)Quality Audits at Suppliers and Contractors (ZAIS-SOP-01092)Quality Agreements with Suppliers (ZAIS-SOP-01487)TRAININGTraining of Personnel (ZAIS-SOP-00043)Recruitment, Selection and Qualification of Personnel (ZAIS-SOP-01428)SELF INSPECTIONGMP Self-Inspection Audits (ZAIS-SOP-00052)COMPLIANCEOPERATIONSDeviations (ZAIS-SOP-00353)Customer Complaints (ZAIS-SOP-00054)Change Requests (ZAIS-SOP-00034)Releases (ZAIS-SOP-01797, 00177 and 00174)Archive (ZAIS-SOP-01549 and 01811)Retention Store (ZAIS-SOP-00271 and 00352)AQL SOP (ZAIS-SOP-00690)OPERATIONSSYSTEMSDocument Management (ZAIS-SOP-00002, 00003 and 01870)Annual Product Quality Reviews (ZAIS-SOP-00006)Quality Modules Implementation (ZAIS-SOP-00372)Stability program (ZAIS-SOP-00148)SYSTEMSHUMAN RESOURCERecruitment & SelectionJob ProfileEmployment Offer & Acceptance(ZAIS-SOP-01428)Onboarding & InductionTraining & Development PlanTraining (by QA)(ZAIS-SOP-00043)Performance Management Process Approved by : McMullen, Heather Signature :Date : Approved by : Qunta, Thembile Signature :Date : Approved by : Dayimani, Ntombekhaya Signature :Date : Approved by : Strydom, Conrad Signature :Date : Reviewed by : Silvo, Gloria Signature :Date : Compile by :0.3617 Simelane, Bonginkosi Signature :Date : Approved by : Neculicioiu, Christian Signature :Date : Approved by : Urbani, Carla Signature :Date : Approved by : Kilian, Dewald Signature :Date : Approved by : Signature :Date : Kate, Sudam SANDOZ SPARTAN, SA – Quality Management System and Material Flow Ver. 02Version HistoryVersion No.: Reason: 01 Added method validations to QC department Compiled by :
publish time: 2021-04-04
Baiano Simelane

This is a Biovac product process mapping, from which you can see the data integrity. A process map visually depicts the sequence of events to build a product or produce an outcome. Process mapping is an important tool for the manufacturing industry. Like a blueprint, mapping takes the overall manufacturing procedure. Check more details from this diagram, and try to make yours with ease.

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