Transcription
Company LogoCOMPANY B.Address: xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxCONTROLLEDBATCH MANUFACTURING RECORDDOCUMENTFilling Building #Department NamePage NoPage 1 of 27Blending, Filling, Lyophilization andSealingProduct XX dose LyophilisedxxxxxxxTitleProduct NameShort TextProduct CodeIssued By (Q.A ):Document NoVersion NoProcess OrderBatch NoMBR-xxxxxxX########xxxxxxDate :Production Manager :Date :INDEXNoDescriptionPage NoSummary of ProcessSummary of ActivitiesBatch FormulationThawing of Bulk AntigenLyophilizer Trays ProcessingRubber Stopper ProcessingProcessing Product contact Material for Pooling & FillingVial ProcessingRoom Pressure RecordingPreparation of LyophilizerVerification of Bulk Antigen Container Weights.Pooling & Clarification of Thawed Bulk and Preparation of Final BulkIntegrity Testing of Product FilterFillingIntegrity Test of Vent FiltersLoading of LyophilizerLyophilizationAluminum cap processingSealing of vialsMaterial Reconciliation recordBulk reconciliation recordBMR CertificationOfficer Incharge:(Checked by)Date:
Company LogoCOMPANY B.Address: xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxCONTROLLEDBATCH MANUFACTURING RECORDDOCUMENTFilling Building #Department NamePage NoPage 2 of 27Blending, Filling, Lyophilization andSealingProduct XX dose LyophilisedxxxxxxxTitleProduct NameShort TextProduct CodeDocument NoVersion NoProcess OrderBatch NoMBR-xxxxxxX########xxxxxxThe entire activity has the following major steps:ActivityDay No1.Thawing of Bulk Antigen2.Cleaning and Sterilization of Lyophilizer Trays3.Sterilization and Drying of Rubber StoppersCleaning, Preparation and Sterilization of Material4.Required for Filling and Pooling5.Cleaning and Sterilization / Disinfection of Lyophilizer6.Washing and Sterilization of Vials7.Pooling and Clarification to Prepare ‘Final Bulk’8.Filling of Vaccine into VialsLoading of Filled Vials in the Lyophilizer and9.Lyophilization10. Sterilization and Drying of Aluminium Caps11. SealingDay 1Day before fillingDay 2Day of fillingDay 3Day after filling133323333333343Day 42nd day after fillingDay 53rd day after fillingSealed vials with lyophilized vaccine are handed over to Screening Dept. for visual inspection.Pages 5 and 6 to be issued to Bulk section who will fill the details and send it back.Pages 25 To 27 to be issued to Lyophilization section who will fill the details and send it back.Officer Incharge:(Checked by)5Date:
Company LogoCOMPANY B.Address: xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxCONTROLLEDBATCH MANUFACTURING RECORDDOCUMENTFilling Building #Department NamePage NoPage 3 of 27TitleProduct NameShort TextProduct CodeBlending, Filling, Lyophilization andSealingProduct XX dose LyophilisedxxxxxxxDocument NoVersion NoProcess OrderBatch NoMBR-xxxxxxX########xxxxxxSUMMARY OF ACTIVITIESTarget Lyophilizer NumberLyophilizer Batch CapacityVolume per vialBatch Volume as Dispensed by Bulk Mfg DeptDate of FillingFill volume per vial (xx x xx) (Overfill mid point at X %)Batch Volume as Rechecked by Filling DeptTheoretical Batch SizeApprox Filling Yield. [Quantity loaded in Lyophilizer]Approx Sealing Yield. [Quantity transferred to screening]XXXXVialsmL (23)L (24)dd/mm/yyyymL (25)LVials (28)Vials (22)Vials (19)Note: Acceptable variation between 24 and 26 which is caused by removal of outer packaging / doublebagging should not be more than X %Activity: BATCH FORMULATIONRef SOP No:Select the bulks for the batch on the basis of bulk Ag titre, volume, filling volume per vial, and batchsize. Filling personnel* to cross check in terms of Weights on receipt.ComponentBulk Ag No.Antigen TitreVol. ‘L’*Gr WtTare Wt‘kg’‘kg’Limit XX L X%Set Ag Titre / vialProduct XActual Vol.LkgkgVolume / Formulation: Dt:Weighing: Dt:vialDone by Checked by Done byChecked byX mLRemarks:-Officer Incharge:(Checked by)Date:
Company LogoCOMPANY B.Address: xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxCONTROLLEDBATCH MANUFACTURING RECORDDOCUMENTFilling Building #Department NamePage NoPage 4 of 27Blending, Filling, Lyophilization andSealingProduct XX dose LyophilisedxxxxxxxTitleProduct NameShort TextProduct CodeActivity : THAWING OF BULKSDocument NoVersion NoProcess OrderBatch NoMBR-xxxxxxX########xxxxxxRef SOP NO:The Bulks should be removed for thawing not more than xx Hours prior to estimated time of start offilling.THAWING DETAILSParticularsProduct #12DiluentRemoved for thawing on (date)Location of cold roomBldg NoBldg NoCR NoCR NoRemoved for thawing athhIncubator set tempºCºC(Range xx to xx C)Thawing completed on (date)Thawing completed athhNoNameHandling of Bulk Antigen Containers Done ByInitialsDate1234Bulk Antigen Containers Received By:Remarks if any:Officer Incharge:(Checked by)Date:
Company LogoCOMPANY B.Address: xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxCONTROLLEDBATCH MANUFACTURING RECORDDOCUMENTFilling Building #Department NamePage NoPage 5 of 27Blending, Filling, Lyophilization andSealingProduct XX dose LyophilisedxxxxxxxTitleProduct NameShort TextProduct CodeActivity :LYOPHILIZER TRAY PROCESSINGDocument NoVersion NoProcess OrderBatch NoMBR-xxxxxxX########xxxxxxRef SOP No :1. Clean the trays to be used for collecting filled vials using a clean lint free mop wetted with WFI/xx %Isopropyl alcohol.2. The trays can be processed in either of two waysA) Load the cleaned trays on the dry heat sterilizer (DHS) trolley, as per validated max loadingpattern in DHS No xxxx and sterilize at xxx C, xxx minutesB) Load the trays in Autoclave and sterilize at xxx C x C for XX minutesNo of TraysPattern NoPattern No3. If option A above is selected, run the cycle to hold the trays at xxx C for xxx minutes. Normalvariation –x to x C4. Write Product, B.No., Charge No & date on the sterilizer thermograph/printout (for Option A only)sign it and attach it to this BMRNo1234Description of ActivityNo of trays cleanedQuantity for batches:Loaded cleaned trays onto the trolley .Loaded in SterilizerLoad pattern noCharge No# xxxxxxxxxxxx# xxxxxxxxxxxxChecked Cycle parameters A) xxx C, xxx minutesB) xxx C x C for xx minutesSterilization temperature xxx C achieved at(applicable for option A above)Sterilization temperature xxx C maintained till(applicable for option A above)Done ByhhRemarks:-Officer Incharge:(Checked by)Date:CheckedByDate
Company LogoCOMPANY B.Address: xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxCONTROLLEDBATCH MANUFACTURING RECORDDOCUMENTFilling Building #Department NamePage NoPage 6 of 27TitleProduct NameShort TextProduct CodeBlending, Filling, Lyophilization andSealingProduct XX dose LyophilisedxxxxxxxActivity : RUBBER STOPPERS PROCESSINGDocument NoVersion NoProcess OrderBatch NoMBR-xxxxxxX########xxxxxxRef SOP No :1. Verify that QC approved stoppers of correct type have been taken for de-cartoning.2. For RFS stoppers, after de cartoning directly move to sterilization.3. Load stoppers as per validated loading pattern given belowRFSMax No of stoppers / pouchesxxxxPattern No for Autoclave XxxxxPattern No for Autoclave Yxxxx4. The stoppers can be processed in either of the two ways:A) Sterilization in Autoclave X (xxx to xxx C) and drying in dry heat sterilizer (DHS) NoB) Sterilization and drying in Autoclave Y.In both the cases, carry out sterilization at 121 C for xxx minutes, Write Product, B.No., Charge Noand date on the sterilizer printout / thermograph sign it and attach it to this BMR5. If option A above is selected, then transfer the sterilized rubber stoppers from the autoclave to theDHS from clean room side for drying. Start drying cycle: xxx C for xxx mins. Normal variation - x C to x C/ x min. If option B above is selected then Sterilize stoppers at xxx C x C for xxxminutes followed by a drying cycle for xxx mins in the autoclave. In case of greater variation intemperature or time, the deciding factor will be the moisture content. Write Product, B.No., ChargeNo and date on the sterilizer thermograph /printout (for Option A only) sign it and attach it to thisBMR.6. Draw one sample for Moisture content analysis (Limit NMT xxx mg/stopper). In case stoppers of 2batches are sterilized in 1 load, draw only 1 sample, record both batch nos on TRF, attach copies toboth BMRsA) Stopper input: xx mm, Lyo Grey Butyl Rubber1) Unprocessed b/f: 2) Processed b/f:3) Fresh quantityB.NoB.NoissuedActually Loaded for Sterilization9) No of stoppersPouchesUnprocessed4) Fresh used fromissueDone byRemarks:Officer Incharge:(Checked by)Date:5) Option forProcessA 1 2 4B 1 4Checked byDate
Company LogoCOMPANY B.Address: xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxCONTROLLEDBATCH MANUFACTURING RECORDDOCUMENTFilling Building #Department NamePage NoPage 7 of 27Blending, Filling, Lyophilization andSealingProduct XX dose LyophilisedxxxxxxxTitleProduct NameShort TextProduct CodeActivity : RUBBER STOPPERS PROCESSING, cont'dDocument NoVersion NoProcess OrderBatch NoMBR-xxxxxxX########xxxxxxRef SOP No :7. Load pouches on the Autoclave trolley as per validated loading pattern.Autoclave No. /Equipment No.#################Charge No.XXXXDHS No / Equip X####################Drying temperature xxx C for xxx minutes for drying in DHSAchieved at :Quantityfor 1 / 2batchesChargeNo.:Done byXCheckedbyDatehMaintained till:hSample for Moisture Content (11)Nos.NOTE: Filling activity should not be started before the result of moisture content estimation is receivedfrom Q.C.Remarks:Officer Incharge:(Checked by)Date:
Company LogoCOMPANY B.Address: xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxCONTROLLEDBATCH MANUFACTURING RECORDDOCUMENTFilling Building #Department NamePage NoPage 8 of 27Blending, Filling, Lyophilization andSealingProduct XX dose LyophilisedxxxxxxxTitleProduct NameShort TextProduct CodeDocument NoVersion NoProcess OrderBatch NoMBR-xxxxxxX########xxxxxxActivity : PROCESSING PRODUCT CONTACT MATERIAL FOR POOLING AND FILLINGRef SOP No :1. Use filters based on the following table for B.Size for Filtration xx L2. Carry out pre-filtration integrity test using the following dataINTEGRITY TESTING OF xx µm FILTERMakeNamePart NoQuantity/batchBubble PointABDiffusionTst pr.RateXXXXxx 1xx 2xx 3YYYYyy 1yy 2No bubbles at ‘A’, Bubbles should be seen ‘B’, Units: BP, Diffusion Pr: Bar, rate: mL/minA) Pre-Sterilization Integrity TestingApplicationStageMethodStep APresteriliz’nManualAutoMfg/ BrandXXXXXXXXFilter Lot NoPart NoFilter S.NoEquipmentEquipment NoXXXXXXXXFilter DetailsPore SizeWetting Liq.Test Parameterxx umWFIObservationBubbles seenat barResultPrintoutattachedRemarks:-Officer Incharge:(Checked by)Date:DonebyTest TypeBubble PtDiffusionCheck Dateby
Company LogoCOMPANY B.Address: xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxCONTROLLEDBATCH MANUFACTURING RECORDDOCUMENTFilling Building #Department NamePage NoPage 9 of 27Blending, Filling, Lyophilization andSealingProduct XX dose LyophilisedxxxxxxxTitleProduct NameShort TextProduct CodeDocument NoVersion NoProcess OrderBatch NoMBR-xxxxxxX########xxxxxxActivity : PROCESSING PRODUCT CONTACT MATERIAL FOR POOLING AND FILLINGRef SOP No :1. Inactivation: Inactivate the Material used for Pooling and Filling in the Autoclave by heating it toxxx C for x minutes. Record in the autoclave Log Book. (Variation xx C to xx C)2. Preparation: Unload the inactivated material from the Autoclave on the Washing room side; Washinactivated material by passing Cooled WFI. Draw a sample from the tanks & check conductivity.Draw samples from Tanks, Silicon tube to header, Header, Syringes, needles & screen forparticulates. In case the previous product is Media fill, draw additional samples submit to QC withProduct Changeover TRF. On clearance wrap in sterilization pouches.3. In case the vent filters on BV2 are new, carry out WIT and attach the results on opposite page. In casethey continue from the previous day, the Post use integrity test of the previous batch will be treated asthe pre-use integrity test of this batch.4. Check the plan for the next day & select the loading pattern. Load the wrapped material on theautoclave trolley as per validated loading pattern. Attach a list of material sterilized, to this BMR.Write Product, B.No., Charge No and date on the sterilizer printout / thermograph (for Autoclave XXonly) sign it and attach it to this BMR.Check xxmS/cmmS/cmItemFibresParticlesSampled by:Conductivity check on product tank rinse sample NMT 1 mS/cmBV1BV2Product C/ODone by CheckedbymS/cm mS/cmNATRF attachedVisual Inspection of Product Contact material rinse sampleBV 1BV 2Silicon tubeHeaderSyringeScreened by:DateNeedleDate:STERILIZATION OF MATERIAL FOR POOLING AND FILLINGAutoclave No / Equip No1Load Pattern number2Charge No3Program No4Remarks:-Officer Incharge:(Checked by)######### / ########XXXXXXXXXXXXXXXXXXXXDone byDate:Checked byDate
Company LogoCOMPANY B.Address: xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxCONTROLLEDBATCH MANUFACTURING RECORDDOCUMENTFilling Building #Department NamePage NoPage 10 of 27Blending, Filling, Lyophilization andSealingProduct XX dose LyophilisedxxxxxxxTitleProduct NameShort TextProduct CodeActivity :VIAL PROCESSING – WASHINGDocument NoVersion NoProcess OrderBatch NoMBR-xxxxxxX########xxxxxxRef SOP No :1. Verify that QC approved vials of correct type have been taken for de-cartoning.2. De-carton the Vials, transfer them into clean SS trays and pass them to the washing area.3. Ensure WFI cooling assembly is sanitized before commencing Washing of xst batch. Ensure pressureof Fresh and Recycled WFI and compressed air, conductivity of Fresh WFI are within limits. Ensurearea is free of previous product vials4. Perform Test for Adequacy using X washed vials.5. After operation is completed, drain the WFI assembly and clean the machineA) Vial input: x mL, xx mm X xx mm height, (Amber, tubular, USP type-1)1) Unprocessed2) Processed3) Fresh qty4) Fresh used fromb/f:b/f:issuedissueB.NoB.No5) Option for6) Taken for washing: A 1 2 4ProcessB 1 4B Pre-washing and Washing operation checks:WFI coolingass’ly sanitizedLine ClearanceCheckedYes / NoYes / NoWashing Media OutletPressure (Range ‘Bar’)S
BATCH MANUFACTURING RECORD CONTROLLED DOCUMENT Department Name Filling Building # _ Page No Page 1 of 27 Title Blending, Filling, Lyophilization and Document No MBR-xxxxxx Sealing Version No X Product Name Product X - - Short Text X dose Lyophilised Process Order ##### Product Code xxxxxxx Batch No xxxxxx Officer Incharge: Date:File Size: 254KBPage Count: 27
