Product Questionnaire 1 2 3 4 5 01: Contact InformationCompany Name*Company Address* Street Address Address Line 2 City State / Province / Region ZIP / Postal Code AfghanistanAlbaniaAlgeriaAmerican SamoaAndorraAngolaAnguillaAntarcticaAntigua and BarbudaArgentinaArmeniaArubaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelgiumBelizeBeninBermudaBhutanBoliviaBonaire, Sint Eustatius and SabaBosnia and HerzegovinaBotswanaBouvet IslandBrazilBritish Indian Ocean TerritoryBrunei DarussalamBulgariaBurkina FasoBurundiCambodiaCameroonCanadaCape VerdeCayman IslandsCentral African RepublicChadChileChinaChristmas IslandCocos IslandsColombiaComorosCongo, Democratic Republic of theCongo, Republic of theCook IslandsCosta RicaCroatiaCubaCuraçaoCyprusCzech RepublicCôte d'IvoireDenmarkDjiboutiDominicaDominican RepublicEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEswatini (Swaziland)EthiopiaFalkland IslandsFaroe IslandsFijiFinlandFranceFrench GuianaFrench PolynesiaFrench Southern TerritoriesGabonGambiaGeorgiaGermanyGhanaGibraltarGreeceGreenlandGrenadaGuadeloupeGuamGuatemalaGuernseyGuineaGuinea-BissauGuyanaHaitiHeard and McDonald IslandsHoly SeeHondurasHong KongHungaryIcelandIndiaIndonesiaIranIraqIrelandIsle of ManIsraelItalyJamaicaJapanJerseyJordanKazakhstanKenyaKiribatiKuwaitKyrgyzstanLao People's Democratic RepublicLatviaLebanonLesothoLiberiaLibyaLiechtensteinLithuaniaLuxembourgMacauMacedoniaMadagascarMalawiMalaysiaMaldivesMaliMaltaMarshall IslandsMartiniqueMauritaniaMauritiusMayotteMexicoMicronesiaMoldovaMonacoMongoliaMontenegroMontserratMoroccoMozambiqueMyanmarNamibiaNauruNepalNetherlandsNew CaledoniaNew ZealandNicaraguaNigerNigeriaNiueNorfolk IslandNorth KoreaNorthern Mariana IslandsNorwayOmanPakistanPalauPalestine, State ofPanamaPapua New GuineaParaguayPeruPhilippinesPitcairnPolandPortugalPuerto RicoQatarRomaniaRussiaRwandaRéunionSaint BarthélemySaint HelenaSaint Kitts and NevisSaint LuciaSaint MartinSaint Pierre and MiquelonSaint Vincent and the GrenadinesSamoaSan MarinoSao Tome and PrincipeSaudi ArabiaSenegalSerbiaSeychellesSierra LeoneSingaporeSint MaartenSlovakiaSloveniaSolomon IslandsSomaliaSouth AfricaSouth GeorgiaSouth KoreaSouth SudanSpainSri LankaSudanSurinameSvalbard and Jan Mayen IslandsSwedenSwitzerlandSyriaTaiwanTajikistanTanzaniaThailandTimor-LesteTogoTokelauTongaTrinidad and TobagoTunisiaTurkeyTurkmenistanTurks and Caicos IslandsTuvaluUS Minor Outlying IslandsUgandaUkraineUnited Arab EmiratesUnited KingdomUnited StatesUruguayUzbekistanVanuatuVenezuelaVietnamVirgin Islands, BritishVirgin Islands, U.S.Wallis and FutunaWestern SaharaYemenZambiaZimbabweÅland IslandsCountry Contact Name*Title*Email* 02: Product InformationClassification of ProductDrugMedical DeviceCompound Classification Monoclonal Antibody Oligonucleotide Peptide Small Molecule Protein Safety Data Sheet (SDS) Request Drop files here or Additional Classification Potent Hormone Antibiotic Cytotoxic Other N/A OtherRegulatory Phase Preclinical Phase III Process Validation Phase I Registration Commercial (Branded) Phase II 505(b)(2) Commercial (Generic) What agency is the filing going to? US EU Asia Other If US, What is your regulatory pathway? NDA BLA ANDA CBER CDHR If EU, What is your regulatory pathway?If Asia, What is your regulatory pathway?If Other, What is your regulatory pathway?How will the API or BDS be supplied?PowderSolution (API only)Solution Concentration (dilution required)Solution Preformulated (ready to filter and fill)API or BDS Storage Condition20-25 ⁰C2-8 ⁰C-20 ⁰C-40 ⁰C-80 ⁰COtherOtherAPI or BDS Storage ConditionProduct Use/IndicationRoute of Administration Intravenous Subcutaneous Intramuscular Intravitreal Other OtherRoute of Administration 03: Manufacturing InformationPresentationVialPre-filled syringeDropper bottleComponent informationSize2 mL10 mL60 mL3 mL25 mL100 mL5 mL30 mLOther6 mL50 mLSize1 mL1 mL long2.25 mL3 mLSize5 mL10 mLFill volume per vial (mL)Fill volume per syringe (mL)Fill volume per bottle (mL)Concentration per vial (mg/mL)Concentration per syringe (mg/mL)Concentration per bottle (mg/mL)Conditional BreakManufacturerPart number / DescriptionTypeTubingMoldedAmberClearOtherTypeCZClearGraduatedTreatedGlassPolymerTypeISOCustomizedBottle manufacturerBottle part number / DescriptionBottle colorNozzle manufacturerNozzle colorNozzle size40 μL60 μLOtherOther - Nozzle sizeCap manufacturerCap part number / DescriptionCap colorStopper manufacturerStopper part number / DescriptionStopper coatingTeflonFluorotecB2OtherStopper / Plunger manufacturerStopper / Plunger part number / DescriptionStopper / Plunger coatingTeflonFluorotecB2OtherOtherStopper / Plunger coatingCrimp seal manufacturerCrimp seal part number / DescriptionCrimp seal colorWhat excipients are required?ExcipientGrade (USP, EP, NF, etc.)VendorPart NumberClient or LSNE Supplied Type of batches Engineering Placebo Clinical Registration/Exhibit Process Validation For each type of batch selected show the following questions:EngineeringHow many runs?Batch size (vials)Formulation volume (liters)Target release dateWill engineering material be used for B&E/I&F?YesNoPlaceboHow many runs?Batch size (vials)Formulation volume (liters)Target release dateClinicalHow many runs?Batch size (vials)Formulation volume (liters)Target release dateRegistration / ExhibitHow many runs?Batch size (vials)Formulation volume (liters)Target release dateProcess ValidationHow many runs?Batch size (vials)Formulation volume (liters)Target release dateNon-conditional FieldsResets field visibility.Is the API or BDS water soluble?YesNoAny special handling requirements Hydroscopic Light sensitivity Oxygen sensitivity Shear sensitivity Temperature control N/A Additional InformationSterile filtration of final product?YesNoSterile compound formulation?YesNoHas filter validation been performed?YesNoStudies Performed Bubble Point (water) Bubble Point (product) Microbial Retention Extractable / Leachables Other OtherAdditional InformationIncompatible material Nylon Polycarbonate Polyethylene Polypropylene Polystyrene Polyvinyl Silicone Stainless steel Unknown Other OtherIncompatible materialPresentationLiquidLyophilizedPresentationLiquidSuspensionEmulsionVisual inspectionExpedited visual inspection due to stabilityStandard visual inspectionSpecial visual inspection criteria Colored Appearance Free of particulate Precipitation N/A Labeling and Packaging Bulk labeling and packaging Kitting Individual vial labeling Ink jetting Secondary labeling Secondary packaging 04: Safety InformationDoes the formulation contain organic solvents?What is the validated detection method?What is the validated cleaning method?What is the ID test method?Does product/formulation have any microbial effects?Assigned PDE/OEL/Potency data, if known?Deactivation Agent CIP100 Bleach Spor Klenz Other OtherDeactivation Agent 05: Drug Product TestingIs analytical method development needed?YesNoMore information for analytical method developmentWhat release testing is required? Appearance UV/Vis pH Residual Moisture (Karl Fischer) HPLC/UPLC (assay/purity & impurities) Reconstitution Time Residual Solvent by GC Endotoxin Particulate Matter (USP <788>) Sterility Osmolality Other If there are multiple HPLC or GC methods please add additional informationIf ICH Stability is required please confirm which batches will be set down on stabilityConditions KeyA = -20°C B = 2-8°C C = 25°C/60%RH D = 30°C/65%RH E = 40°C/75%RHPlease add applicable conditions for each assay using the condition key above.Container Closure Integrity1M3M6M9M12M18M24M36M48MAppearance1M3M6M9M12M18M24M36M48MReconstitution Time1M3M6M9M12M18M24M36M48MpH1M3M6M9M12M18M24M36M48MHPLC1M3M6M9M12M18M24M36M48MResidual Moisture1M3M6M9M12M18M24M36M48MParticulate Matter1M3M6M9M12M18M24M36M48MEndotoxin1M3M6M9M12M18M24M36M48MSterility1M3M6M9M12M18M24M36M48MUV/Vis1M3M6M9M12M18M24M36M48MOtherWhat additional ICH stability testing is required?Other1M3M6M9M12M18M24M36M48M
