BATCH MANUFACTURING RECORD FOR PRODUCT X,

Transcription

1 Expiry PRODUCT X FILL SIZE x ml Effective Written : Revision number: Reviewed : Approved Q.A.:

2 Expiry CERTIFICATION CERTIFICATE OF QUALITY ASSURANCE THIS IS TO CERTIFY THAT THE BATCH No. OF PRODUCT X (TRADE NAME ), SATISFIES THE REGULATORY AND PHARMACOPOEIAL REQUIREMENTS FOR PRODUCT X VACCINE. Signature of Quality Assurance: Date : Effective Written : Revision number: Reviewed : Approved Q.A.:

3 Expiry 1. BATCH RECORD REVIEW AND APPROVAL REPORT No Term Details 1 Name of the Product PRODUCT X 2 3 Date of Filling 4 Filled 5 Released 6 Mfg. Date 7 Exp. Date Reviewed QA (Analyst/Officer): Approved Head QA: 2. CHECKLIST OF BATCH RECORD: No Description Date 1 Product X Vaccine Blending 2 Primary packing materials procurement 3 Washing and sterilization of vials, stoppers and vessels. 4 Sterilization of filling items 5 Filling 6 Filling particulars 7 Recording of deviations 8 Primary packing materials reconciliation record 9 Visual Inspection 11 Packing details for shipment to NCL 12 Finished goods transfer note to NCL Document availability checked Production QA Signature of Supervisor: Signature of Quality Assurance: Date : Effective Written : Revision number: Reviewed : Approved Q.A.:

4 Expiry 3. QUALITY CONTROL REPORTS AND MISCELLANEOUS DOCUMENTS CHECK LIST: No Name of the Report Q.C Ref.No. 1 Formulation buffer 2 Final Blend report (1) 3 Final Blend report (2) 4 Filled vials report (1) 5 Filled vials report (2) 6 Thermo graphs of Autoclave NA 7 Vials Depyrogenation report NA 8 Membrane Integrity report NA 9 Environmental monitoring report NA 10 Particle count report NA 11 NCL report NA 12 WFI report of blending port NA 13 WFI report of washing port NA Availability checked Production QA Signature of Supervisor: Signature of Quality Assurance: Date : Effective Written : Revision number: Reviewed : Approved Q.A.:

5 Expiry 4. Product X VACCINE BLENDING: 4.1 Volume of blend: Liters. 4.2 Details of blending materials: Description of material Lot No / B. No Q.C. Ref No. Assay (mg/ml) A) Bulk antigen (xx mg/ml) (SOP # / Spec # ) B) Formulation solution #1 (xx mg/ml) (SOP # ) C) Formulation solution #2 (xx mg/ml) (SOP # ) Signature of Supervisor: Date : 4.3 Bulk antigen requirement for blend: Antigen requirement: Calculate the antigen requirement for the blend as per SOP # Blend volume in ml (A) Total antigen required in mg (A x XX) / Details of antigen: Lot No. Q.C. Ref of Bulk No. and Date Antigen concentration in mg/ml (A) Volume in ml (B) Total antigen in mg A x B As mentioned above Total volume Total rounded off to Signature of Supervisor: Date : Effective Written : Revision number: Reviewed : Approved Q.A.:

6 Expiry 4.4 Solution #1 (FS#1) requirement for the blend: Solution #1 (FS#1) requirement: Calculate Formulation Solution #1 requirement for the blend as per SOP # Blend volume in ml Total XXXX required in mg (Blend volume x XX mg/ml) Details of Formulation Solution #1 (FS#1) No. Q.C. Ref. No. and Date FS#1 content (mg/ml) (A) Volume in ml (B) Total FS#1 in (mg) (A x B) as mentioned above Signature of Supervisor: Total volume Total round off to 4.5 Requirement of Formulation Solution #2(FS#2) for the blend: Formulation Solution # (FS#2) requirement: Refer SOPs# Blend volume In (ml) A Total Bulk Volume (ml) B Total FS#1 Volume (ml) C Required quantity of FS#2 (ml) D = A- (B+C) Blending vessel Particulars: 1 Type of vessel XXX liter blending vessel 2 Make XXX 3 ID.No. ####### 4 Cleaned 5 SIP cycle No / Load No 6. LAFU Validation Done on: Due on: Line clearance given QA Effective Written : Revision number: Reviewed : Approved Q.A.:

7 Expiry Details of blending : Ingredient Temp of Spec. Volume Added Checked Date vessel o C o C/ % added FS#1 as per xx to xx o C FS#2 as per xx to xx o C Bulk antigen as per xx to xx o C Stirring (%) xx xx % Stirring start time:. End time: (stirring time specifications: X to X hrs) Signature of Supervisor : Signature of Quality Assurance : Date : Date : 4.6 Final blend sampling details: For sample collection, labeling, storage details refer SOP# Sampled xx ml Sampled Date and Time Tests to be done Description ph XXX content XXX content Bacterial Endotoxins (LAL) Sterility XXX Potency SOP.No/ Spec No Q.C.Ref. No. and Date Report Date Signature of Supervisor : Signature of Quality Assurance : Date : Date : Effective Written : Revision number: Reviewed : Approved Q.A.:

8 Expiry 5. PRIMARY PACKING MATERIALS PROCUREMENT: No Name of material 1 X ml vials 2 xx mm grey butyl stoppers 3 xx mm aluminium seals Remarks (if any) : Spec.No. AR.No required issued store received Checked Production supervisor Q.A. in charge Signature of Supervisor : Signature of Quality Assurance : Date : Date : Effective Written : Revision number: Reviewed : Approved Q.A.:

9 Expiry 6. WASHING AND STERILIZATION OF STOPPERS AND FILLING ITEMS: 6.1 Stoppers details: Size: xx mm Colour: grey butyl Machine particulars: Name of the machine: STOPPER WASHING MACHINE I.D. No. xxxxxx Validation Done on: Due on: Cleaned Checked LAFU I.D. No: Validation Due on: Treatment of stoppers: Treatment procedure of stoppers as per SOP # of treatment solution (TS#1) required for stoppers: Total volume of WFI (ml) (A) Total TS#1 required in mg at XX mg/ml (A x XX) Details of TS#1 treatment: (Final TS#1 concentration should be xx mg/ml) No Ingredient STP.No./ Spec.No. A.R. No. Qty Required 1 TS#1 xxx mg 2 WFI NA xxxx ml Qty weighed Weighed Checked Volume of TS#1 solution prepared Volume of TS#1 solution used Volume of TS#1 solution discarded Excess TS#1 solution discarded : Checked : TS#1 treatment of stoppers done : Date Checked : Effective Written : Revision number: Reviewed : Approved Q.A.:

10 Expiry mm Grey butyl rubber Stopper washing particulars: Stopper washing, WFI inspection procedure refer SOP # Drain water of Stopper washing machine checked Lot No I Washing details: No Date Operator involved in washing 1 st rinse 2 nd rinse 3 rd rinse Start Time Washing End Time Qty Washed. Final rinse drain water inspected Details of Stopper Collection into S.S cans for Stopper Lot No I: Can No Date S.S can cleaned No. of stoppers collected Collected Thiomersal solution Volume added Added Checked Repeat as necessary for as many lots of Stoppers that are required Sterilization of stoppers: Sterilization procedure of stoppers and sterilization autoclave refer SOP # Equipment particulars: Name of the Machine and Make AUTOCLAVE XXXXXXX I.D. No. ####### Validation Done on: Due on: Cleaned : Checked : Details of stopper sterilization as per load pattern No : 1 Date Load No. Can No Qty Loaded Sterilization temp Sterilization time Specification xx min at XX o C Unloaded Signature of Supervisor : Effective Written : Revision number: Reviewed : Approved Q.A.:

11 Expiry 6.2 Details of filling accessories sterilization as per load pattern No 2 Washing and sterilization of filling accessories refer SOP# Date Load No. Items Qty Washed & Loaded Sterilization temp Sterilization time Specific'n Filling # sets with glass syringes Stopper # Bowl Chute # Picker # wheel Section # wheel Glass # syringes Forceps # Silicon # tubes 20 L # pressure vessel SS tray # xx min at XX o C Unloaded Checked Signature of Supervisor : Garments Gloves Wipes Mask xx min at XX o C 6.3 Details of garments, gloves and wipes sterilization as per load pattern No 3 Date Load No. Items Qty Loaded Sterilization temp Sterilization time Specification Unloaded Checked Signature of Supervisor : Effective Written : Revision number: Reviewed : Approved Q.A.:

12 Expiry 6.4 Fumigation of blending and filling area: Fumigating procedure refer SOP# Area Date Formaldehyde WFI Fumigation done From Time To Check-ed Signature of Supervisor : Signature of QA: Effective Written : Revision number: Reviewed : Approved Q.A.:

13 Expiry 7. WASHING AND DEPYROGENATION OF VIALS. 7.1 Washing of vials : Vial washing, inspection and depyrogenation procedure as per SOP # Machine particulars: Equipment Name: XXXXXXXX Make XXXXXXX ID.No. ########### Validation Done on: Due on: Cleaned Checked : Parameter Results Air pressure: (Spec x to x Kg/cm 2 ) Water pressure: (Spec x to x Kg/cm 2 ) Final rinsing WFI Temperature: (Spec xx to xx o C) Flow of water in all needles Flow of air in all needles Checked Date & Time Signature of Supervisor : Date : Vial washing particulars : LAFU I.D. No: ############# Date WFI sample Time of washing inspected Start Time End Time Vials loaded Validation Due on: Washing Total No. machine of vials operated Washed No. of vials broken Total Effective Written : Revision number: Reviewed : Approved Q.A.:

14 Expiry Washed vials inspection (For particles) : ( Frequency every x hours) Date Time Checked Remarks Signature of Supervisor : Date : 7.2 Depyrogenation of vials: Machine particulars: Equipment Name and Make XXXXXXX I.D. No. ######## Validation Done on: Due on: Cleaned : Checked : Depyrogenation Details : Date Tunnel start time Set Temp Depyrog'n O C Heater 1 Heater 2 Heater 3 Heater 4 Tem p O C (> X) Time Min. ( x) Tunnel stop time Tunnel Drive mm/min < xxx Temp monitored Depyrog'n data enclosed Yes/no Checked depyrog'd Signature of Supervisor : Date : Effective Written : Revision number: Reviewed : Approved Q.A.:

15 Expiry 8. FILLING PARTICULARS: 8.1 Filling line clearance : line clearance as per SOP# LAFU I.D. No: ######### Validation Due on: Machine particulars and line clearance details: Equipment Name Filling Machine Stoppering Machine Sealing Machine Make XXXXX XXXXX XXXXX I.D. No. ######## ######## ######## Room No. Validation done on Validation due on Cleaned Checked Sterilization indicators on stoppers, filling items, garments etc Checked Verified QA Filling area cleanliness Fumigation details Line clearance for filling given QA: 8.2 Filling operation particulars: Filling Operation: Filling operation refer SOP # Filling Operation Details: Date Time Filling Machine operator Stoppering Machine operator Sealing Machine operator Filled vials collected Signature of Prod. Shift incharge Signature of QA. Shift incharge Signature of Supervisor : Date : Effective Written : Revision number: Reviewed : Approved Q.A.:

16 Expiry 8.3 Final blend stirring: (Frequency of checking - Every x hour) Stirring and temperature of vessel as per SOP# Date Time Stirring (%) Specification Checked (%) Production QA xx - xx Signature of Supervisor : Date : 8.4 Volume variation check during filling : Filling operation: Filling operations, start up activities refer to SOP # and to annex for fill volume standards. Volume variations action limits refer SOP# Volume check up Details : ( Frequency every x to x hours) Filling Starting time: Closing time: Pack Size X ml Syringe used for vol. Measurement: X ml Fill Volume Specification xx.x xx.x ml Calibration due on: Volume drawn Nozzle Nozzle Nozzle Nozzle Nozzle No Date Time No-1 No-2 No-3 No-4 No-5 Start up volume checks in (ml) Nozzle No-6 In process Volume checks during filling in (ml) Signature of Supervisor : Date : Checked Remarks Effective Written : Revision number: Reviewed : Approved Q.A.:

17 Expiry 8.5 Filling area monitoring : ( Frequency every x hours) Filling Starting time: Pack size: X ml Closing time: Date Time Temp ( o C) Spec ( o C) Humidity (%) Spec (%) Checked xx to xx o C xx to xx% Signature of Supervisor : Date : 8.6 Recording of Interferences/deviations during filling: Deviation action limits and procedures followed refer SOP# Note: This is the provision to record online interferences during filling if any. Possible deviations: power failure, temperature out of specification, stirring of blend out of specification, Fill volume out of specification, equipment problems etc. Crate No Date Time Description of Interference/Deviation Recorded By Checked Deviation report No. if any Note: This table helps to trace those vials that could have been filled during interferences.(if filled during interferences) Signature of Supervisor : Date : Effective Written : Revision number: Reviewed : Approved Q.A.:

18 Expiry 8.7 Filled vials sampling details for QC: Collection of samples Refer SOP# and for Number of samples Refer SOP Date Sampled Sampled QA Tests to be done S.O.P./ Spec No. Q.C. Ref. No and Date xx Vials Description Identity ph XX content XX content Abnormal toxicity on guinea pigs Abnormal toxicity on mice Sterility Bacterial endotoxins (LAL test) Potency Closure integrity test Report checked Prod. Report verified QA Signature of Supervisor : Signature of Quality Assurance : Date : Report Date 8.8 Calculation of practical yield : Theoretical Total Process Loss (B) Yield (A) = Batch Vol. Filling Vol Description Volume in ml Checked Prod. Verified QA a) Sampled of final blend b) No. of volume checked vials c) Vol. discarded after breaks d) Dead Volume Total (B) Process Loss (%) = B X 100/A Equivalent vials Filled (C) No. of samples for Q.C. Testing (D) xx transferred to Visual inspection E = C- D Effective Written : Revision number: Reviewed : Approved Q.A.:

19 Expiry 9. PRIMARY PACKING MATERIALS RECONCILIATION: Name of Material XX ml Vials Stoppers xx mm grey butyl Seals xx mm issued Total used Returned to stores Process loss % Spec (%) x x x REMARKS (if any): Signature of Supervisor : Signature of Quality Assurance : Date : Date : 10.MATERIAL RETURN NOTE: 10.1 Material Return Note Number : 10.2 Material Return Details : No Item code Description AR No. Indent No. Units Reason for Returning REMARKS (if any): Returned By : Approved By : Received By : Signature of Supervisor : Signature of Quality Assurance : Date : Date : Effective Written : Revision number: Reviewed : Approved Q.A.:

20 Expiry 11. VISUAL INSPECTION OF VIALS : 11.1 Line clearance for visual inspection : refer Line clearance SOP# Cleaning of visual inspection area: Cleaning procedure refer SOP # Area cleaned : Checked : Date : Line Clearance Details : No Previous product Present product Batch No. Pack size Batch No. Pack size Previous product material cleared off from the area Yes /No Checked. By Line clearance given QA Date Time Signature of Supervisor : Signature of Quality Assurance : Date : Date : 11.2 Reconciliation of vials after Visual inspection :refer SOP# Received for Visual inspection: Reconciliation Details : No Date Time From To Tested Checked Passed random checked Passed Less volume (A) Rejected vials as per possible defects Glass pieces (B) Other particles (C) Total Passed Total rejected % rejection Specification of optical rejection: x % Cap Closures defects (D) Good transferred to labeling after Visual inspection: Signature of Supervisor : Signature of Quality Assurance : Date : Date : Total (A+B+C+D) Effective Written : Revision number: Reviewed : Approved Q.A.:

21 Expiry 12. DISCARD NOTE: Date Item Reasons for destruction Destruction approved Destruction Destroyed Supervised Production QA Formulation Solutions Glass Vials xx mm stoppers xx mm flip top seals Visual inspection rejections Signature of Supervisor : Signature of Quality Assurance : Date : Date : 13. BATCH ACCOUNT: 13.1 Details of batch account: 1 Theoretical yield 2 Filled quantity (b) 3 No. of vials given for Q.C + other samples 4 No. of vials given for visual inspection 5 Total Optical rejections + breakages during optical testing (e) 6 Passed quantity after Visual inspection. 7 No. of vials packed and sent to NCL 8 Net percentage Yield = (b - e X100)/b 9 remaining to be labeled and packed Batch packing details: P.R.No. Date Breakages Packed No. of Samples Transferred Total Signature of Supervisor : Signature of Quality Assurance : Date : Date : remaining Effective Written : Revision number: Reviewed : Approved Q.A.: