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Sr. No.Change in(Item)Impact On(Due to change in item)Supportive Data / Justification Required1Mfg. Formula / Components and compositionBatch mfg. RecordTrainingStability Studies/Shelf lifeLabel claim of printed PMRegulatory approvalProduct permissionProcess validationPartial analytical method validation (e.g. In case of change in colour of tab, placebo interference should be checked)FP specification & ATP.In process specification & ATPStability protocolBill of Raw MaterialRevision of FO/MICleaning validationCustomer approvalChange of MBR,PBR,PI,MIIn process & FP analytical trendSupportive data received from SPARC / FDDScientific rationale2Manufacturing SiteBatch mfg. recordAnalytical documentsTrainingProcess validationSame working principle of machines/equipmentEquipment QualificationScientific rational.Equipment equivalence3Batch sizeBatch mfg. recordTrainingProcess validationBill of Raw MaterialRegulatory approvalRevision of MF and MI or PI or MPREquipment design and qualification statusIn process & FP analytical trend.4Critical manufacturing equipment/Batch mfg. RecordTrainingEquipment equivalence (operating principle, design, operating parameters, mfg. capacity), impact on productCalibration of the equipment.Equipment QualificationEquipment equivalence5Cleaning ProcedureCleaning validationCleaning validation/Verification protocolSr. No.Change in(Item)Impact On(Due to change in item)Supportive Data / Justification Required6Mfg. procedureBatch mfg. record.TrainingStability Studies/Shelf life.In process & FP analytical TrendSupportive data receivedfrom SPARC/FDD7Instrument / machineStandard Operating Procedure (SOP).Training to the chemist/analyst.Master BMR/ Analytical documentsSupportive data to prove no impact on core quality.8FP SpecificationFP STPStability protocolTraining to the analystMethod validationFP Template/ LIMSBatch mfg. recordAny supportive document received from FDDFP analytical trend / historical dataChange in pharmacopoeial limit / parative data study9Test methodATP (Analytical test procedure)Training to AnalystImpact on available lots/batchesAnalytical method validationAnalytical Tech TransferSupportive data from FDDAny pharmacopoeialreferenceComparative study data10Stability protocolStability specificationStability analytical test procedureTraining to analystAny supportive document received from FDD.Change in Pharmacopoeiallimit / method.11RM specification.RM standard test procedure.Raw material inventory system.RM directory/sample justification sheet.BMR and BOMLabel claim of printed packing material, if applicable.Training to the analyst.Method validationRM Template/ PLIMSRM analytical trend.Any supportive document received from FDDChange in pharmacopoeiallimitComparative data studyRM analytical trend/historical data.Sr. No.Change in(Item)Impact On(Due to change in item)Supportive Data / Justification Required12In the process specification/ control specificationIn process analytical test procedure.Batch mfg. record.Training to the analyst.Process ValidationCleaning ValidationStability studiesRegulatory approvalRevision of specificationCustomer approvalImpact on controlling/monitoring instrumentIn process analytical trendAny supportive document received from FDDComparative study data13Secondary(printed/ un-printed) packaging material.Batch packing record.Packing material specification and ATPPack profileTraining to the analystPackaging material inventory system.Copy of revised artwork of printed pkg. material.Justification for the change.14Shelf LifeMaster BMR Stability study/ Stability protocolChange in specificationCustomer ApprovalRegulatory approval or effect Specification (material sampling & handling sheet)Supportive data from FDDSupportive stability study15RM Source / SupplierStability Study ( if active )Stability protocol Vendor approval Regulatory effectAPI Specification and ATPsInclusion of vendor in approved vendor listProcess ValidationVendor QualificationMethod Transfer , if requiredComparative study between different RM lot Comparative study of finished product manufactured from these RM16Any standard formats / System.Standard Operating Procedure(SOP). Training to the analyst.Any audit comment.Reference of any incidence report Supportive trend / literature.Sr. No.Change in(Item)Impact On(Due to change in item)Supportive Data / Justification Required17Change in item code of API/ Excipient /Intermediate/Raw materialAll products BMR/BOM in which material is used.ERPSpec/ATP/Stability protocolPackage insert/label/foilProcess validation protocolVendor QualificationIdentification of affected stock for HOLDIdentification of affected stock for RejectionRegulatory approvalRevision of finished product specificationRevision of raw material specificationRevision of FO/MI packing materialSupportive data to prove no impact on FP quality.18Inclusion ofnew pack sizeRevision of stability protocol.Stability study.Process validation.NDC code inclusion in PI orrevision of PI.Packing order.Revision or of pack style.Processing of ArtworkPO/PI PreparationMarketing requirement19Change in Tablet Description:Addition /deletion of break line / quarter line Change in embossing / debossingChange in shape of break line (fish shape /straight line)Trail to break the tablets.One batch Dissolution /CU of half tablet – One time study, Friability, Package insert, Stability protocol.BMR, Process validation protocol. (exhibit/stability)Reporting category as per SUPAC and rmation to FDA.FDD recommendationSr. No.Change in(Item)Impact On(Due to change in item)Supportive Data / Justification Required20Inclusion ordeletion ofpack size orcount per bottle.Package insert (NDC code).Packing order.Pack style.Marketing requirement.21Existing Product/Equipment/DiscontinuationCleaning validation for worst case identification/MACO calculationsRejection of raw material/packing material stock or transfer to other locationDecision for continuation ofstability studyUpdation of Product planningTo cancel the order of rawmaterials/packing materialsUpdate of cleaning validation matrixRetrieval of Operational copies of FO/MI, PO/PIRetrieval of Operational copies of SOPUpdate calibration calendar, PM calendar, RQ Calendar, Inventory ListProduct discontinuation instruction details22Site TransferAvailability of identical equipmentVMP/Facility Qualification/Equipment/Critical Utility QualificationWhether batch size has been changedProcess validationCleaning ValidationAnalytical method transfer/Mfg. Tech TransferStability StudyMF/MBR revisionAvailability of manufacturing licenseApproval by regulatoryResource adequacy in terms of manpower and infrastructure Product informationSr. No.Change in(Item)Impact On(Due to change in item)Supportive Data / Justification Required23New ProductVendor QualificationAvailability of regulatory approvalStability studyInclusion of vendor in approved vendor listApproval of MF and MI (Manufacturing Instructions)Approval PO (Packaging Order) and ( PI (Packaging Instruction)Process validationAvailability of scale-up reportAvailability of test batch/exhibit batch monitoring reportCleaning ValidationResource adequacy in terns of human resources and infrastructure requirementsImpact on contamination/containment issuesAnalytical test method development verification/validation Product details24New equipmentIdentical equipmentDesign qualificationInstallation qualificationUtilities requirementsOperational qualificationPerformance qualificationOperation and cleaning SOPCleaning validationProcess validationRevision of MI/PIPreventive Maintenance SOPCalibration of SOPStability StudiesEquipment equivalenceRegulatory approval Update in equipment inventory /RQ (Re-qualification) CalendarUpdate in calibration calendarUpdate in preventive maintenance calendar Equipment qualificationSr. No.Change in(Item)Impact On(Due to change in item)Supportive Data / Justification RequiredEquipment LogSterilization SOPUpdate Equipment LayoutUpdate Validation matrix (VMP)Microbiology (E. g. Media fill, EM)Special TrainingSpecialized resourcesRevision to as built engineering diagrams25Change in EquipmentUtilities requirementsCleaning validationProcess validationRevision of MI/PIStability StudiesEquipment equivalenceRegulatory approval Update in equipment inventory /RQ (Re-qualification) CalendarUpdate in calibration calendarUpdate in preventive maintenance calendarEquipment Log/ History recordSupplementary qualification or IQ/OQ/PQ Change in facility.26Change in Layout/FacilityIs there a change in layoutEnvironment control as per specialization (HVAC)Area qualification/ Re-qualificationContamination/cross contaminationSpecial trainingImpact on available resourcesApproval of regulatory agencyRevision to as built engineering diagrams Changes in Site master file 27Change in utility equipmentSupplementary qualification or IQ/OQ /PQRevision of SOPRevision of MI/PIRevision of PM SOPUpdate in equipment inventory/RQ calendar Change in utility equipmentSr. No.Change in(Item)Impact On(Due to change in item)Supportive Data / Justification RequiredUpdate in calibration calendarUpdate in preventive maintenance calendarRevision to as-built engineering diagrams28Change in art work/Packaging material/Labelling changeRevision of PO/PIRevision of art workRevision of packaging specificationRegulatory approvalIdentification of affected stock for HOLD and Blocking of existing code for further orderingDestruction of negative/plates at vendor endMarketing approvalIdentification of affected stocks for Rejection Art work 29Change in VendorAPI specs and STPsMethod transfer, if requiredVendor QualificationInclusion of vendor in approved vendor listStability studyRegulatory approval availableProcess validationRevision of FO/MI, or PO/PI Vendor qualification30Change in Document (Specification/STP/ SOP/ProtocolDocument revisionRegulatory approvalTraining System implementation31Regulatory agencyAny requirement of regulatory agency Regulatory requirement 32Personal and General IssuesCustomer requirementMarketing requirement Requirement 33GxP Computer systemChange in GxP category 3, 4, 5 computer systems, Revision of SOPChange in infrastructure componentsSupplementary qualification or IQ/OQ/PQ Computer system qualification ................
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