GMPIVZ-Druck.fm Seite 1 Mittwoch, 26. September 2012 1:00 13 GMP . - PDA
GMPIVZ-Druck.fm Seite 1 Mittwoch, 26. September 2012 1:00 13GMP MANUAL ContentsGMP MANUAL ContentsPharmaceutical Quality System (PQS)1.APreface1.BThe road to a Pharmaceutical Quality System1.C1.C.11.C.2Introduction to the PQSGeneral in elements of a PQSManagement responsibilityResource managementManufacturing operationsEvaluation activities1.E1.E.11.E.21.E.31.E.4Essentials of a PQSPrinciples of a processProcess mappingResponsibilitiesKey Performance Indicators (KPIs)1.F1.F.11.F.21.F.31.F.4Practical implementation of a PQSAssistance for implementationOrganizational aspectsProcess of developing documentsDocument hierarchy1.GStructure of a PQS quality manual – example1.HCorrelation between GMP requirements (WHO) and ISO9001:20001.IReferences2Personnel2.APlace of work and job descriptions2.B2.B.12.B.2Requirements of the personnelQualification requirementsHealth requirementsContents1GMP Manual (Up14) Maas & Peither AG – GMP Publishing(1)www.pda.org/bookstore
GMPIVZ-Druck.fm Seite 2 Mittwoch, 26. September 2012 1:00 13ContentsGMP MANUAL .C.8TrainingPurpose of trainingResponsibility for trainingRequirements profiles/learning objectivesTraining contents and target groupsTraining planningCarrying outReviewing the training and the training .6Function owners subject to public lawQualified Person (QP)Head of ProductionHead of Quality ControlQualified Person in Accordance withArticle 103 of Guideline 2001/83/ECScientific Service in Charge of InformationMedical sales .53.A.6Official RequirementsLocation, connection to other roomsSize, area, heightInstallation and supply of utilitiesLighting, ventilation, air-conditioningHygienic constructionRoom book and layout3.B3.B.13.B.23.B.33.B.4Material flow, personnel flow and layoutMaterial flowPersonnel flowLayoutDesign concepts in FDA’s Sterile Drug ProductsProduced by Aseptic Processing m classesGeneral GMP Requirements for PremisesGMP Requirements for Cleanrooms: Air Cleanliness GradesCorresponding FDA DeterminationsGMP Requirements for PremisesRoom-specific Allocation of Air Cleanliness StipulationsCleanliness Zoning ConceptsConverting GMP Stipulations into RealityGMP Manual (Up14) Maas & Peither AG – GMP Publishingwww.pda.org/bookstore
GMPIVZ-Druck.fm Seite 3 Mittwoch, 26. September 2012 1:00 133.D3.D.13.D.23.D.33.D.4Construction elementsWallsDoors and r systems and isolatorsProtection concepts for maximized sterility assurancePharmaceutical isolator technologyRestricted access barrier systems (RABS technology)Application options for RABS and isolators3.F3.F.13.F.23.F.33.F.43.F.5Building servicesBasic requirements for installationHeatingSanitary plumbing and sewageElectrical installations incl. IT-management and control G.6Heating Ventilation Air Conditioning (HVAC)IntroductionRoom ventilation systemsFiltersPrinciples for the design and planning of airconditioning ventilation systemsDesign criteria for the ventilation of premisesMaintenance of air ventilation systems3.H3.H.13.H.23.H.33.H.4Process GasesQuality RequirementsGeneration, Storage and DistributionSystem designQualification and I.8Qualification of premises and air-conditioning systemsObjectives of qualificationRegulatory and normative fundamentals of qualificationProject development and qualificationQualification Master PlanQualification Plans and Qualification ReportsQualification checklistsRequirements for measurement and test reportsRequalification3.J3.J.13.J.23.J.3Monitoring of HVAC systemsObjectives of process monitoringData management stipulationsAir cleanliness and other room air dataGMP Manual (Up14) Maas & Peither AG – GMP PublishingContentsGMP MANUAL Contents(3)www.pda.org/bookstore
GMPIVZ-Druck.fm Seite 4 Mittwoch, 26. September 2012 1:00 13ContentsGMP MANUAL Contents(4)3.J.43.J.53.J.6Risks of microbiological monitoringAlarm and action limitsOperation and maintenance3.KReferences4Facilities and al componentsConstruction and installation materialsGMP-compliant design characteristicsElectrical and pneumatic components4.CControl4.D4.D.14.D.24.D.3Facility conceptsCIP (Cleaning in Place)Isolator technologyConnected facilities4.E4.E.14.E.24.E.3Examples of facility qualification,Design qualificationInstallation qualificationOperational qualification4.F4.F.14.F.24.F.34.F.4Technical documentationNecessityScope and contentAdministration of the technical documentationLog rocedureDocumentationAdministration of scheduled calibration dates/ times4.H4.H.14.H.24.H.3MaintenanceTypes of maintenanceGMP-conforming maintenanceSystems for maintenance4.I4.I.14.I.24.I.34.I.4CIP (Cleaning in Place)IntroductionCIP systemsGMP-conforming design of CIP facilitiesNozzle heads for container cleaningGMP Manual (Up14) Maas & Peither AG – GMP Publishingwww.pda.org/bookstore
GMPIVZ-Druck.fm Seite 5 Mittwoch, 26. September 2012 1:00 134.I.54.I.6Measuring technologyRealisation of cleaning 4.J.94.J.104.J.11Containment (personnel protection)in solids handlingSignificanceDefinition of termsContainment grades of productsMeasurement of the residue limits (OEL)Example of containment facility planningContainment weak pointsContainment systems for filling and emptying drumsContainer systemsFilter systemsSamplingContainment on equipment4.K4.K.14.K.24.K.34.K.44.K.5Process control systemsDefinitionsFeatures of process control systemsHow to use process control systemsCarrying out a process control system projectQualification of process control 4.L.9Hygienic (sanitary) design when using solidsIntroductionSurfacesMaterial: stainless steelConnectionsHoists and roller conveyorsPneumatic conveyor systemDosing systemsPlatforms and standsClean room installations5Pharmaceutical Water5.A5.A.15.A.25.A.35.A.4Water typesPotable waterPurified waterHighly purified waterWater for injection5.B5.B.15.B.25.B.3Generation of pharmaceutical waterPurified water (PW)Water for injection (WFI)Purification of pharmaceutical water treatment systemsGMP Manual (Up14) Maas & Peither AG – GMP PublishingContentsGMP MANUAL Contents(5)www.pda.org/bookstore
GMPIVZ-Druck.fm Seite 6 Mittwoch, 26. September 2012 1:00 13ContentsGMP MANUAL istribution and storage of pharmaceutical waterLoopFixturesMeasuring techniqueFormation of biofilmsRougingBuffering of ultra pure waterLoop with 8Qualification of water suppliesIntroductionRisk analysisDesign qualificationInstallation qualificationOperational qualification (OQ)Transfer to the userProcess validation/performance qualification (PQ)Qualification report5.E5.E.15.E.25.E.35.E.45.E.55.E.6Operation of water suppliesProcedures to reduce microbial countsMaintenance of a water supplyCalibration of measuring systemsChange 5.F5.F.15.F.25.F.35.F.4Pure steam systemsPhysical principlesQuality requirements for pure steamPure steam generationPure steam distribution A.66.A.76.A.8Official requirementsLegal aspects of qualificationDocumentation of the qualificationDesign Qualification (DQ)Installation Qualification (IQ)Operational Qualification (OQ)Performance Qualification (PQ)Qualification of established facilitiesRequalificationGMP Manual (Up14) Maas & Peither AG – GMP Publishingwww.pda.org/bookstore
GMPIVZ-Druck.fm Seite 7 Mittwoch, 26. September 2012 1:00 13GMP MANUAL ContentsPreparation of the qualificationCommissioningSequenceQualification teamResponsibilitiesQualification by external service providersRisk analysis6.C6.C.16.C.26.C.36.C.46.C.5Qualification documentationQualification master planQualification planQualification reportLabeling of the qualification statusSOP – “Qualification of facilities and equipment”6.D6.D.16.D.2Design qualification (DQ)User requirements (user specifications)Technical specification6.E6.E.16.E.2Installation qualification (IQ)Examples of IQ plansExample: Fluid bed equipment6.F6.F.16.F.2Operational qualification(OQ)Examples of OQ plansExample: Fluid bed dryer6.GPerformance qualification (PQ)6.H6.H.16.H.26.H.36.H.46.H.5Special cases of qualificationRetrospective qualificationRequalificationContent of a reviewMaintenance of the qualified statusQualification of simple equipment7Process Validation7.A7.A.17.A.27.A.37.A.47.A.5Official requirementsRegulative aspectsPrinciples of process validationTypes of process validationMaintaining the validated statusDocumentation of process validation7.B7.B.17.B.2Validation – a key element of quality managementWhat is the significance of validation?How is validation MP Manual (Up14) Maas & Peither AG – GMP Publishing(7)www.pda.org/bookstore
GMPIVZ-Druck.fm Seite 8 Mittwoch, 26. September 2012 1:00 13ContentsGMP MANUAL Contents(8)7.B.37.B.47.B.57.B.67.B.7Who must perform validation?What faults can occur during validation?What are the benefits of validation?Current trends in process validationProcess validation from the viewpoint of the FDA7.C7.C.17.C.27.C.3Validation planning and procedureProcess validation approachesPrerequisites and responsibilitiesScope of Validation7.D7.D.17.D.27.D.37.D.47.D.5Validation documentationStructure and archivingValidation master planValidation protocolValidation reportDocumentation examples7.E7.E.17.E.27.E.37.E.4Process Validation and Product LifecycleQuality by DesignProcess Analytical Technology (PAT)Maintaining the validated stateProcess validation as a three-stage life cycle model7.FReferences8Cleaning Validation8.AOfficial requirements8.B8.B.18.B.28.B.3How to validate cleaning proceduresOptimization of cleaning proceduresCompilation of cleaning instructionsValidating manual and automated cleaning procedures8.CCleaning validation master plan8.D8.D.18.D.2Establishing the scope of validationBracketing: determination of critical substancesMatrixing: determination of equipment-specific validation protocols8.E8.E.18.E.28.E.3Acceptance criteria and limit calculationCalculation of active pharmaceutical ingredient residuesCalculation of cleansing agent residuesDetermination of the microbial status8.F8.F.18.F.2Sampling proceduresSwab testRinse testGMP Manual (Up14) Maas & Peither AG – GMP Publishingwww.pda.org/bookstore
GMPIVZ-Druck.fm Seite 9 Mittwoch, 26. September 2012 1:00 138.F.38.F.48.F.5Other proceduresSelection of the appropriate sampling procedureMicrobiological testing of surfaces8.G8.G.18.G.2Analytical proceduresRequirements for method validationSelection of the appropriate analytical procedure8.H8.H.18.H.28.H.3DocumentationValidation protocolValidation reportOther documents8.I8.I.18.I.28.I.38.I.48.I.5Maintenance of the validated statusChanges and deviationsChange controlRevalidationNew products and equipmentDeviations8.JCleaning validation documentation (example)8.KReferences9Computer System Validation9.AIntroduction and terminology9.B9.B.19.B.29.B.39.B.49.B.5Legal aspectsEuropeUSAPIC/SElectronic signatures and electronic recordsISPE GAMP 5 – Good Automated Manufacturing Practice9.C9.C.19.C.29.C.3System life cycleThe “V model”Software developmentConfiguration and customisation9.D9.D.19.D.2System classification and risk managementSystem classification according to ISPE GAMP 5Risk management9.E9.E.19.E.29.E.39.E.4Validation of computerised systemsValidation organisationValidation planSpecifications (user requirements/technical specification)Unit, integration, system and acceptance testsGMP Manual (Up14) Maas & Peither AG – GMP PublishingContentsGMP MANUAL Contents(9)www.pda.org/bookstore
GMPIVZ-Druck.fm Seite 10 Mittwoch, 26. September 2012 1:00 13ContentsGMP MANUAL Contents9.E.59.E.69.E.79.E.8Validation reportData migration and start-upExamplesRetrospective F.89.F.9Operation of computerised systemsSystem descriptionUser trainingStandard operating procedures (SOPs)Access and securityData backup and archivingContingency plansChange management and error reportingPeriodic reviewRetirement of computerised systems9.G9.G.19.G.29.G.3External service providersRelocation of activitiesService level agreementAuditing of suppliers and service providers9.HReferences10Considerations on Risk Introduction and PrinciplesAdvantages of Risk ManagementConsiderations on the Risk-Based ApproachRegulatory EnvironmentObjectivesScience-Based ApproachSummary10.BBasic Consideration on Implementing Risk Management Into aProcessAreas of HazardsPrerequisitesUse of Knowledge and ExperienceConsideration on Manual OperationsElements of Risk ManagementImplementation of a Risk Management ProcessCommitment of ManagementProject TeamAnalysis of Existing Risk Management ApproachesStandardization of Methods and ToolsConsiderations on Risk Based BehaviorAdditional Training 710.B.810.B.910.B.1010.B.1110.B.12(10)GMP Manual (Up14) Maas & Peither AG – GMP Publishingwww.pda.org/bookstore
GMPIVZ-Druck.fm Seite 11 Mittwoch, 26. September 2012 1:00 1310.C10.C.110.C.210.C.310.C.410.C.510.C.6Details on Using Risk Management Principles as BehaviorApplication to the QM SystemThe TeamAssessment CriteriaProcedure to Determine ConclusionsEvaluation on Individual Topics (DetailedEvaluation) Using Risk ManagementExample on Process Validation10.DMethodologies to be Used to Facilitate Risk Management10.EUsing Process Mapping10.F10.F.110.F.2Using a Fishbone DiagramCreate a Fish Bone DiagramAdvantages and Disadvantages10.GInformal Use of Risk Fault Tree Analysis (FTA)Basic PrinciplesObjective: What a FTA Can Do and Where to Use ItHow to Run the Process of a FTAPrerequisites for an FTAExecution of an FTAAdvantages and Disadvantages of an FTA10.I10.I.110.I.210.I.310.I.410.I.5Failure Mode Effects Analysis (FMEA)Objectives and Areas of ApplicationGeneral Items on the FMEA ProcessImplementation of FMEA in a ProjectAdvantages and Disadvantages of an FMEAApplication Example of a Modified FMEA10.J10.J.110.J.210.J.3Hazard Analysis of Critical Control Points (HACCP)Prerequisite and Result to be ExpectedAdvantages and DisadvantagesApplication 1.A.3SanitationOrganisational prerequisitesSources of contaminationResponsibilities and implementationGMP Manual (Up14) Maas & Peither AG – GMP PublishingContentsGMP MANUAL Contents(11)www.pda.org/bookstore
GMPIVZ-Druck.fm Seite 12 Mittwoch, 26. September 2012 1:00 13ContentsGMP MANUAL onnel hygieneClothingCode of ConductHand disinfectionHealth on hygieneSources of anitation programmeOrganisation of room 1.E.511.E.6Environmental monitoringGeneralSampling planEstablishment of limits and frequenciesMethodsInvestigation areasEvaluation11.FGMP in the production process11.G11.G.111.G.211.G.311.G.4Weigh-inLegal requirementsWeigh-in principlesWeigh-in IdentificationHandling of labelsLabelling of starting materialsLabelling of equipment and containersLabelling of rooms11.I11.I.111.I.211.I.311.I.4In-process controlObjectivesOrganisation and responsibilitiesCarrying outDocumentation and evaluation of data11.J11.J.111.J.211.J.3Prevention of cross-contaminationCauses of cross-contaminationMeasures to prevent cross-contaminationManufacture of critical productsGMP Manual (Up14) Maas & Peither AG – GMP Publishingwww.pda.org/bookstore
GMPIVZ-Druck.fm Seite 13 Mittwoch, 26. September 2012 1:00 13GMP MANUAL iesMeasuresFailure investigation reportEvaluation of measuresSOP “deviations” – (example)Check-list for deviation gDefinitionsProcedureRework/Reprocessing of rejected productsRework of returned productsRework of products that have not been .M.711.M.811.M.9Warehouse and logisticsRegulatory requirementsStock management systemResponsibilitiesPersonnelStorage areasStorage conditionsSanitation and pest controlMaterial FlowProcess onRequirements for logistic service providersTransportation challenges and monitoring devicesCool/Cold Chain DistributionTemperature ProfilesTransportation Risks11.OReferences12Sterile Manufacturing of terminally sterilised productsAseptic processingSterilisation proceduresGMP regulations, standards and .511.K.611.K.711.K.8GMP Manual (Up14) Maas & Peither AG – GMP Publishing(13)www.pda.org/bookstore
GMPIVZ-Druck.fm Seite 14 Mittwoch, 26. September 2012 1:00 13ContentsGMP MANUAL Contents(14)12.B12.B.112.B.2Air Lock ConceptsPersonnel locks in the clean areaMaterial locks12.C12.C.112.C.212.C.312.C.412.C.5Manufacture of terminally sterilised productsIntroductionManufacturing a batchWashing .D.412.D.512.D.6Sterilisation processesIntroductionNormative background of sterilisationSterilisation methodsSteam sterilisationDry heat sterilisationRadiation ptic processingRoom requirementsMonitoringPersonnelSterile filtrationValidating aseptic processing (media fill)12.F12.F.112.F.212.F.312.F.4Freeze-dryingThe concept of freeze-dryingFreeze dryer designProcess monitoring and controlQualification and process validation in freeze-drying12.G12.G.112.G.212.G.3Testing for SterilityIntroductionParametric releaseSterility 12.H.8Testing for EndotoxinsIntroductionMethods for detection of endotoxinsTests According to PharmacopeiaAction LimitsGel-Clot TestPhotometric MethodsElimination of Interfering SubstancesOut of Specification (OOS)GMP Manual (Up14) Maas & Peither AG – GMP Publishingwww.pda.org/bookstore
GMPIVZ-Druck.fm Seite 15 Mittwoch, 26. September 2012 1:00 1312.I12.I.112.I.212.I.3Testing for Leakage and for ParticlesTesting for LeakageTesting for ParticlesOperating 2.J.712.J.812.J.9Microbiological monitoringIntroductionSources of contaminationRoom classificationMonitoring programLevelMethods and equipmentSamplingMeasures if levels are exceededOrganism 3.A.213.A.313.A.413.A.5Packaging n against counterfeit medicinal productsPackaging material ng processAllocation of packaging materialLine clearanceLabellingControl functionsRelease for productionIn-process controlsCleaning primary containersLabellingVariable dataImprintsReconciliationSafety featuresCompletion of a packaging process13.C13.C.113.C.213.C.3Qualification of a packaging lineMaster qualification planDesign qualification (DQ)Installation qualification (IQ)GMP Manual (Up14) Maas & Peither AG – GMP PublishingContentsGMP MANUAL Contents(15)www.pda.org/bookstore
GMPIVZ-Druck.fm Seite 16 Mittwoch, 26. September 2012 1:00 13ContentsGMP MANUAL Contents13.C.413.C.5Operational qualification (OQ)Performance qualification (PQ)14Laboratory Sampling plan (instructions)Notes for the sampling process14.B14.B.114.B.214.B.3ReagentsLabelingUsage and stabilityDocumentation14.C14.C.114.C.2Standards and reference substancesDefinition of different standards and their areas of useHandling, storage and stability14.D14.D.114.D.2Qualifying laboratory instrumentsQualification protocols and reportsSystem suitability test (SST)14.E14.E.114.E.214.E.314.E.4Calibration in the labDefinitionsCalibration instructions and Validation of analytical methodsPrinciplesDefinitions of the 214.G.314.G.414.G.514.G.6Stability testingICH guidelines for stability testsStorage and storage conditionsAnalysesReduction of the study designStability testing in the marketing phaseDefining the retest period for an active pharmaceutical ingredientand the shelf life for a drug product through evaluation of stabilitydata (ICH Q1E)Decision tree for data evaluation for retest period or for APIs or drugproducts (excluding frozen products)Procedure for statistical analysisExamples of the statistical evaluation of stability data14.G.714.G.814.G.9(16)GMP Manual (Up14) Maas & Peither AG – GMP Publishingwww.pda.org/bookstore
GMPIVZ-Druck.fm Seite 17 Mittwoch, 26. September 2012 1:00 13GMP MANUAL ContentsOut-of-specification resultsSignificanceDefinitionsFDA OOS GuidanceExample for handling of an OOS resultTrend tracking14.I14.I.114.I.2Raw data documentationPrinciplesSingle sheet documentation system14.J14.J.114.J.214.J.314.J.4Batch releaseCertification by a Qualified Person and releasein accordance with EC GMP GuidelinesResponsibility for issuing the releasePublication of releaseRelease procedures in l testingTotal microbial countSpecified microorganismsTesting frequenciesMiscellaneous 714.L.814.L.9PharmacopoeiasStructure of PharmacopoeiasGeneral considerationsDevelopment of MonographsEuropean Pharmacopoeia (Ph Eur)British Pharmacopoeia (BP)United States Pharmacopeia (USP)Japanese Pharmacopoeia (JP)International Pharmacopoeia (Ph 15.A.115.A.215.A.315.A.415.A.515.A.6Official RequirementsBasic Principles of DocumentationGMP-relevant DocumentsRequirements of the US GMP RegulationsDocument Management SystemCreating DocumentsControlling and monitoring 5GMP Manual (Up14) Maas & Peither AG – GMP Publishing(17)www.pda.org/bookstore
GMPIVZ-Druck.fm Seite 18 Mittwoch, 26. September 2012 1:00 13ContentsGMP MANUAL Contents(18)15.B15.B.115.B.215.B.3GMP-conforming documentationHandwritten entriesArchivingMaster-SOP – “GMP-conforming Batch documentationManufacturing instructions/recordPackaging instruction and batch packaging recordElectronic batch recordingTesting procedures and test protocolBatch record .715.D.815.D.915.D.10Standard operating procedures (SOPs)CompilationApproval and g an operating procedureAdministrationArchivingExample of an SOP “Compilation andadministration of operating e Master FileIntroductionHistoryFocus of recent update (PE 008-4)Regulatory requirementsGuidelines for structure, contents and extent15.F15.F.115.F.215.F.315.F.415.F.5Annual product review /Product quality reviewDocuments required for an annual product reviewAnnual product review reportCollaboration with a contract manufacturerExample: annual product reviewMaster-SOP for the annual product review15.GReferencesGMP Manual (Up14) Maas & Peither AG – GMP Publishingwww.pda.org/bookstore
GMPIVZ-Druck.fm Seite 19 Mittwoch, 26. September 2012 1:00 1316Research and Development16.AGeneral conditions and legal .616.B.7Development phases and GMP requirementsFormulation developmentAnalytical developmentManufacturing and testing of stability samplesPackaging developmentProcess developmentCleaning verification and validationProcess optimization:Basic principles for process validationUp scaling to pilot plant and production scaleHandover to other manufacturing sites16.B.816.B.916.C16.C.116.C.216.C.3Interfaces to GLP and GCPGLP – Good Laboratory PracticeGCP – Good Clinical PracticeInterfaces between the areas regulated by GMPand those regulated by ture and control of clinical samplesPrerequisites for the approval of clinical investigationsManufacturing of clinical samples and comparator drugsPackaging and labelingControl and release of investigational medicinal productsStorage and shipment of investigational drugsReturns, recalls and destruction of clinical samples16.EDocumentation and recording of changes during development16.FDevelopment .7Quality by design (QbD)IntroductionThe Regulatory FrameworkThe New Quality ParadigmApplying Quality by DesignImplementing Quality by DesignApplication ExamplesOutlook16.HReferencesGMP Manual (Up14) Maas & Peither AG – GMP PublishingContentsGMP MANUAL Contents(19)www.pda.org/bookstore
GMPIVZ-Druck.fm Seite 20 Mittwoch, 26. September 2012 1:00 13ContentsGMP MANUAL Contents(20)17Contractors and 7.A.717.A.8Contract manufactureReasons for contract manufactureProcedure for assigning manufacturing contractsDuties of the contract giverDuties of the contract acceptorContract manufacturer agreementAudits of contract manufacturersSOP for assigning manufacturing contractsFramework contract for contract manufacture and quality tract AnalysisIntroductionLegal backgroundSelection of an external testing laboratoryLiability limitation contractCertificate of AnalysisTransfer of the test to the contract Quality systemsRecordsContracts and quality agreementsSupplier review and controlsSupplier auditsRe-evaluation of SuppliersGMP MANUAL Cross References to 18.B18.B.118.B.218.B.318.B.4Inspection Area-based18.C18.C.118.C.2InspectorsTechnical qualification requirementsPersonal requirementsGMP Manual (Up14) Maas & Peither AG – GMP Publishingwww.pda.org/bookstore
GMPIVZ-Druck.fm Seite 21 Mittwoch, 26. September 2012 1:00 1318.D18.D.118.D.218.D.318.D.4Organization of inspectionsInspection planningInspection preparationCarrying out the inspectionsEvaluation and f-inspectionPurpose of self-inspectionCarrying out the self-inspectionSelf-inspection documentationErrors and remedial actionFollow-up activities18.F18.F.118.F.218.F.3Inspection of contract manufacturersPurpose of the inspection of contract manufacturerCarrying out inspections of contract manufacturerHandling of changes and deviations18.G18.G.118.G.2Inspection of suppliersPurpose of the supplier inspectionCarrying out the supplier inspection18.HQuestionnaire for preparing GMP-inspections18.I18.I.118.I.218.I.3Inspection of API manufacturersPreparation of the inspectionType of inspectionInspection questionnaire18.JReferences19Quality Unit19.AGeneralThis chapter will be part of a later update.19.B19.B.119.B.219.B.319.B.419.B.5The “Qualified Person” according to Directive 2001/83/ECIntroductionLegal background of the European “Qualified Person” regulationsQualification and experienceDuties and responsibilitiesQualified Person and Pharmaceutical Quality Systems19.C19.C.119.C.219.C.319.C.4Change ManagementPrinciples of Change ControlBoundary ConditionsRegulatory aspectsConducting the Change Control ProcedureGMP Manual (Up14) Maas & Peither AG – GMP PublishingContentsGMP MANUAL Contents(21)www.pda.org/bookstore
GMPIVZ-Druck.fm Seite 22 Mittwoch, 26. September 2012 1:00 13ContentsGMP MANUAL Contents(22)19.C.519.C.6Evaluating the Change Control SystemDocumenting the Change D.719.D.8Corrective and Preventive Actions (CAPA)IntroductionRegulatory BackgroundDefinitionsOrganizational IntegrationDocumentation and TrackingEfficacy and SustainabilityEfficient ImplementationSample SOP “CAPA System“19.EReferences20Continual 20.B.520.B.620.B.7Six SigmaDefinitionWhat it is / what it does / how it 520.C.620.C.7Statistical Process Control (SPC)DefinitionWhat it is /what it does / how it 520.D.6Process Analytical Technology (PAT)DefinitionThe Role of PAT in Pharmaceutical ManufacturingRegulatory Perspective and GuidancesPAT instrumentationApplication of PAT in a GMP environmentExamples of PAT Applications20.EReferencesGMP Manual (Up14) Maas & Peither AG – GMP Publishingwww.pda.org/bookstore
GMPIVZ-Druck.fm Seite 23 Mittwoch, 26. September 2012 1:00 1321Active and Inactive A.1421.A.1521.A.1621.A.1721.A.1821.A.19GMP for Active Pharmaceutical Ingredients (APIs)IntroductionQuality managementPersonnelBuildings and facilitiesProcess equipmentDocumentation and recordsMaterials managementProduction and in-process controlsPackaging and identification labelling of APIs and intermediatesStorage and distributionLaboratory controlsValidationChange ControlRe
5.D Qualification of water supplies 5.D.1 Introduction 5.D.2 Risk analysis 5.D.3 Design qualification 5.D.4 Installation qualification 5.D.5 Operational qualification (OQ) 5.D.6 Transfer to the user 5.D.7 Process validation/performance qualification (PQ) 5.D.8 Qualification report 5.E Operation of water supplies
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DPI 610/615 Series is a Druck product. Druck has joined other GE high–technology sensing businesses under a new name—GE Sensing. g Druck Portable Pressure Calibrators DPI 610/615 Series The technically advanced Druck DPI 610 and DPI 615 portable calibrators are the culmination of many years of field e
Der Mensch an Stelle Gottes Seite 360 Adelsrepublik im Himmel Seite 361 Summum bonum ist Gott Seite 362 . Die Freiheitsmütze: Revolte gegen die etablierte Ordnung. Seite 373 Das große Siegel der Vereinigten Staaten Seite 374 Selbst die Flagge kam nicht davon Seite 374
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Druck Limited Fir Tree Lane Groby Leicester LE6 0FH England Tel: 0116 231 7100 Druck Limited 2011 This document is the property of Druck Limited and may not, either in part or whole, be cop ied or otherwise reproduced, communicated in any way to third parties, nor stored in any data processing system, without the express written authority of
DPI 610/615 Series is a Druck product. Druck has joined other GE high–technology sensing businesses under a new name– GE Industrial, Sensing. g Druck Portable Pressure Calibrators DPI 610/615 Series The technically advanced Druck DPI 610 and DPI
Das Klinikum investiert weitere 17 Millionen Euro zum Wohle der Patienten Zahlen, Daten Fakten (Seite 12) Der Wirtschaftsplan für das laufende Jahr ist verabschiedet Neurologie (Seite 18) Die neue Hauptabteilung unter Leitung von Dr. Konhäuser ist in Betrieb Kindersegen (Seite 22) Am 22. Juli erblicken gleich sieben Babys am Klinikum das .
Any dishonesty in our academic transactions violates this trust. The University of Manitoba General Calendar addresses the issue of academic dishonesty under the heading “Plagiarism and Cheating.” Specifically, acts of academic dishonesty include, but are not limited to:
