BATCH PACKING RECORD (BPR)

BATCH PACKING RECORD (BPR)

BATCH PACKING RECORD (BPR)
BMR Title
:
BPR for Tablet
Document No.
:
Batch Size
:
 
Page No.
:

 1 of 15

 

Effective Date
:
 
Review Date
:

Product Name                         :

 

Generic Name                         :

 

Labels Claim)                         : Each _____________________________________ tablet contains:

Batch No.                                :___________________________________________

Batch Size                              :___________________________________________

Date of Mfg.                           :___________________________________________

Date of Exp.                            :___________________________________________

Shelf Life                                 : ___________________________________________ months

Mfg. Licence No.                    :____________________________________________

Percentage of Yield                :____________________________________________

Date of Completion                :____________________________________________

BPR Submission Date             : ____________________________________________

TABLE OF CONTENT

Sr.No                                   CONTENTPAGE NO.
1GENERAL PROCESSING INSTRUCTION PROCESSING
2DISPENSING OF PACKING MATERIAL
3STAGE VICE LINE CLEARANCE
4IN-PROCESS CHECK FREQUENCY
5PRIMARY PACKING
6SECONDARY AND TERTIARY PACKING
7PACKING LINE JOB ALLOCATION
8SHIPPER WEIGHING RECORD
9FINISHED PRODUCT TRANSFER RECORD
10YIELD RECONCILIATION OF FINISHED PRODUCT
11PACKING MATERIAL RECONCILIATION
12QC ANALYSIS / SAMPLING (FINISHED PRODUCT):
13DOCUMENTS RECONCILIATION
14BMR REVIEW
15BATCH RELEASE
  • GENERAL PROCESSING INSTRUCTION PROCESSING:
  • Production Officer/ Executive shall be responsible for monitoring packing process.
  • Clean all vessels, machines and equipments before starting the process, as per respective SOPs & record in respective cleaning record.
  • Clean the processing area as per respective SOP. Do not perform cleaning activity if product is open.
  • Affix appropriate Status labels to equipment/ machine in use and after use.
  • During handling or direct contact to the product/ product intermediate use nose mask and gloves to avoid contact of product/ product intermediate with bare hands.
  • Check temperature and humidity of the primary packing area and record in the table ‘Environmental Monitoring Record’.
  • In case of Batch/Product change over; get the line clearance from QA before starting the operation & record in BPR where ever applicable.
  • Ensure the Calibration status of equipments/ instrument to be used.
  • Collect the Material Dispensed by Warehouse and duly labeled & checked by Production & verified by QA, along with duly filled copy of requisition.
  • Bring all allocated containers of visually inspected, QC tested and QA approved, appropriately labeled Tablet for the batch into primary packing area.
  • Set machine for required pack size, take out web proof and check for correct B. No. Mfg Date, Exp. Date, MRP details etc. checked by Production officer and approval by QA officer. Attach the verified specimen to the BPR.
  • In case, there is more than one AR No. of any Packing material, attach a specimen sample of each to BPR.
  • During packing process check and sort out the Tablets for spots, black particles and broken Tablets, empty pockets, tarring, poor sealing and loose powder. Do not pack such strips; transfer such strips for de-foiling in the primary packing area.
  • Knurling should be uniform & Cutting of strips should be uniform on both the edges and lateral side
  • Open 2 sealed Strips and check for the sealing, if any Tablet stick to the foil or the sealing is not proper then adjust the machine accordingly.
  • Perform & record the In-process checks during the packing process as per the mentioned frequency.
  • In case packing machine is stopped for any reason or for tea/ lunch break, the Tablets must not be allowed to remain between the sealing roller and the feeding channel frame.
  • Pack the strips/ bottles /pouch, which are free from any defect as per packaging plan.
  • After the batch is over carry out the reconciliation of the packing material and record the details.
  • Don’t overwrite the entry, in case there is correction, cancel the entry with single line with sign & date.
  • Wherever applicable, put ‘Ö’when the parameter or performance is satisfactory & put ‘X’ when the performance is not satisfactory.
  • Do not deviate from Standard procedure. Deviation, if required, must be authorized and documented.

 

(2.0) DISPENSING OF PACKING MATERIAL:                           Date: __________________
S. No.Material NameRequired Qty.A R No.Quantity IssuedIssued By.
1.Printed Aluminum Foil
2.Plain Alu. Foil/ PVDC/PVC
3.Bottles & Tabs
4.Pouch
5.Cartons
6.Corrugated Box
7.
8.
Verified By/ On           (Quality Assurance)Received By/On                 (Production)

 

3.0 STAGE VICE LINE CLEARANCE:
DateStageRoom NamePrevious productBatch No. (Previous)Area Cleaned By/ On (Prod.)Checked By/ On (prod.)Verified By/ On (QA)
 Stripping/ Blistering/ Alu-Alu Blister/ Bottle Filling      
      
      
 Carton coding      
      
      
 Packing      
      
      

 

4.0 IN-PROCESS CHECK FREQUENCY:
In-Process Control ParameterObservationsFrequency
Sealing and visual checkCheck for appearance, knurling in strips & printing, no Tablet should stick to  foilEvery 30 min
Leak TestNo pocket cavity of strip should leakEvery 1 Hr +10 min
Carton Coding CheckCheck for accuracy & legibilityEvery 30 min
Carton PackingCheck for No. of strips in a cartonEvery 30 min
Shipper PackingCheck   No. of cartons in a shipperEvery 30 min

 

5.0 PRIMARY PACKING:

  5.1 AREA AND EQUIPMENT LINE CLEARANCE:
Previous ProductBatch No.
Equipments UsedEquipments No.
Temperature

(Limit: NMT 25°C)

Relative Humidity    (Limit: NMT 60 %)
  S.No.Check pointsObservations
ProductionIPQA
Done by

(Operator)

Checked By

(Supervisor/Above)

Verified by

(QA)

1.Ensure the absence of batch documents, labels, materials or any remnants of previous product or batch.
2.Cleanliness of floor, dustbins, containers, tools, vacuum cleaner.
3.Ensure ‘CLEANED’ label is affixed on each equipment.
4.Check the updation of status board & status label which shows the details of activity.
5.Cleanliness of surrounding area of dustbins, containers, tools.
6.Check the proper gowning of personnel
7.Ensure the availability of BMR and Batch documents are completed up to previous stage
Sign & Date
*(Tick “√” whichever is applicable)

 

 5.2 PRODUCT DETAILS AND PACKING PROFILE:

Name of Product        :

Batch No.                    :

Date of Mfg.               :

Date of Exp.               :

Batch Size                   :

Pack Size (Shipper)     :

MRP Rs.                     :

5.3 MACHINE SETTING & RUNNING PARAMETER:
 Instruction:

Fix the stereo of required batch to machine for correct Batch details

Take correct printed Foil/PVC/PVDC and get it checked by Production Officer and verified by QA officer for correct overprinting and take line clearance.

After approval affix this specimen to BPR and start over printing.

Keep the rejected quantity of Foil/PVC/PVDC separately for destruction with proper identification label

Record the printing details in given table

Leftover over printed foil if any should be defaced before sending for disposal

DateTimeTemperature (°C)Leak test

(Pass/ Fail)

Checked by
Forming Roller/ PlateSealing Roller/ Plate
      

 6.0 SECONDARY AND TERTIARY PACKING:

6.1 OVER CODING:

6.1.1 OVER CODING AREA AND EQUIPMENT LINE CLEARANCE:
Previous ProductBatch No.
Equipments UsedEquipments No.
Temperature

(Limit: NMT 25°C)

Relative Humidity    (Limit: NMT 60 %)
  S.No.Check pointsObservations
ProductionIPQA
Done by

(Operator)

Checked By

(Supervisor/Above)

Verified by

(QA)

1Ensure the absence of batch documents, labels, materials or any remnants of previous product or batch.
2Cleanliness of Equipments,floor, dustbins, containers, tools, vacuum cleaner.
3Ensure ‘CLEANED’ label is affixed on each equipment.
4Check the updation of status board & status label which shows the details of activity.
5Cleanliness of surrounding area of dustbins, containers, tools.
6Check the proper gowning of personnel
7Ensure the availability of BMR and Batch documents are completed up to previous stage
Sign & Date
*(Tick “√” whichever is applicable)

6.1.2 INSTRUCTIONS DURING CARTON CODING:

Check the quantity of cartons received for overprinting

Fix the stereo of required batch and set the Domino/ Ink jet Laser machine for correct Batch details

Take correct printed carton and get it checked by Production Officer and verified by QA officer for correct overprinting and take line clearance.

After approval affix this specimen carton to BPR and start over printing.

Keep the rejected quantity of cartons separately for destruction with proper identification label

Record the printing details in given table.

Leftover over carton if any should be defaced before sending for disposal.

6.1.3 IN-PROCESS CHECKS FOR OVERPRINTING:

Write the Batch Over Printing Details after Checking the Correctness of Overprinting Text Matter.

The Batch over Printing Details shall be checked by Production Supervisor/above and verified by QA Supervisor/above.

The Verified Specimen of Mono Carton & Carton and C. Box Label shall be affixed at Specified place in the BPR.

 

S. No.TESTInstructionsOBSERVATIONTIME (Every 30 min.)
Date à
Time à
1.Over Printing Details & Verification
2.Product Name
Batch No.
Mfg. Date
Exp. Date
M.R.P.

 

6.2 Secondary Packing Area and Equipment line clearance:
Previous ProductBatch No.
Equipments UsedEquipments No.
Temperature

(Limit: NMT 25°C)

Relative Humidity    (Limit: NMT 60 %)
  S.No.Check pointsObservations
ProductionIPQA
Done by

(Operator)

Checked By

(Supervisor/Above)

Verified by

(QA)

1Ensure the absence of batch documents, labels, materials or any remnants of previous product or batch.
2Cleanliness of Equipments, Packing Line, floor, dustbins, containers, tools, vacuum cleaner.
3Ensure ‘CLEANED’ label is affixed on each equipment.
4Check the updation of status board & status label which shows the details of activity.
5Cleanliness of surrounding area of dustbins, containers, tools.
6Check the proper gowning of personnel
7Ensure the availability of BMR and Batch documents are completed up to previous stage
Sign & Date
*(Tick “√” whichever is applicable)

6.3 STANDARD WEIGHT AND ACCEPTANCE LIMIT SETTING FOR CARTON AND SHIPPER:

Table No. Sr. No.Weight of one  StripWeight of Empty CartonWeight of filled

Carton

Weight of Empty

Corrugated  Shipper

Weight of filled Corrugated  Shipper
1.

 

     
2.

 

     
3.

 

     
4.     
5.

 

     
6.

 

     
7.

 

     
8.

 

     
9.

 

     
10.

 

     
Total Weight =====
Average weightA=B=C=D=E=
Lower limit of filled Carton =C-(A/2) =
Upper limit of filled Carton =C+(A/2)=
Upper limit of filled shipper=E+(C/2)=
Lower limit of filled shipper=E-(C/2)=
Checked by production (Supervisor or above)

(Sign.& Date)

Verified by (Supervisor or above)

(Sign.& Date)

 6.4 IN-PROCESS CHECKS FOR PACKING OPERATION:

S. No.TESTINSTRUCTIONSOBSERVATION TIME                                                                   (Every 30 Min, Accept  Leak Test -Every 1 Hour)
Date à
Time à
1.Visual Inspection of strips/BlisterProper Sealing with No color Spots / Powder/ Dust
2.Check for Empty PocketsNo Empty Pockets
3.Leak Test (Every 1 Hour)Should comply with Std.  Specification
4.Printing on CartonLegible & Satisfactory Quality
5.Sealing DefectsCheck for visual sealing defects
6.Mfg./Exp. Date, MRP Print QualityClear, Legible,             Non- Spreading
7.Mfg./Exp. Date, MRP CorrectnessShould be same in BPCR, Label, Carton & Shipper
8.Line ClearanceNo packing material left from previous Batch
9.Random Visual InspectionNo empty Pockets in strip, Exact No. of strips  in carton/Cartons in Shipper Box, Properly Labeled Dust Free

 

7.0 PACKING LINE JOB ALLOCATION:
Stage *DateTimeDurationDone ByChecked by
FromTo
Stripping/ Blistering/ Alu-2 Blister/ Pouch filling/ Bottle filling
Strip/ Blister  printing inspection
Induction Sealing (Bottle/ Pouch)
Bottle /
Pouch Labeling
De-foiling
Carton Coding
Carton Packing
Carton Weighing
Shipper Packing
Shipper Weighing

*(Tick “√” whichever is applicable)

8.0  SHIPPER WEIGHING RECORD:                                                                 Date: _________________
S. No.Weight of Shipper (Kg)S. No.Weight of Shipper (Kg)S. No.Weight of Shipper (Kg)
1.11.21.
2.12.22.
3.13.23.
4.14.24.
5.15.25.
6.16.26.
7.17.27.
8.18.28.
9.19.29.
10.20.30.

 

9.0 FINISHED PRODUCT TRANSFER RECORD
Date
Total No. of Shippers (Full)
Total No. of Shippers (Loose)
Quantity Transferred

(No. of shipper X No. of carton/ Bottles X Pack Size of Bottle)

Checked By/ On (Production)
Verified By/ On (QA)

 

10.0 YIELD RECONCILIATION OF FINISHED PRODUCT:
S. No.ParticularsUnits (Lt/ No.)Quantity
1.Quantity received from Manufacturing (Lt)
2.Quantity received from Manufacturing (No.)

(Qty. in Lt/ Unit Fill volume for packing )

3.Quantity Transferred to FG Store
4.Quantity used for Leak Test
5.Quantity used for QC. Analysis
6.Quantity given as Control Sample
7.Quantity given as Stability Sample
8.Quantity given as Reference Sample
9.Process loss
10.Actual Batch Yeild % (3)x100

(2)

(Not less than 97.00 %)

11.Reconciliation Percentage yield    (3+4+5+6+7+8+9)x100

(2)                                   (Not less than 99.00 %)

12.Done By/ On
13.Verified By/ On

 

11.0 PACKING MATERIAL RECONCILIATION:
S. No.Material NameDispensed Qty.Returned Qty.Used Qty.Destroyed Qty.Destroyed By/ On
1.Bottles (……………. ml)
2.PP Caps(…………. mm)
3.Measuring Cap (………ml)
4.Labels
5.Cartons
6.Dropper (…………… ml)
7.Corrugated Box
8.Others (if any)
9.

 

12.0 QC ANALYSIS / SAMPLING (FINISHED PRODUCT):

QC Sample Taken By: ____________________Qty. of Sample:  ________________
Analytical result of Finished Product : Pass/ Fail. A R No.: _____________________Sign/Date:
The Finished Product is released or not released

Sign/Date: (Production)                                                             Sign/Date: (QA)

13.0 DOCUMENTS RECONCILIATION:

Sr.No.DescriptionQuantityProduction (Sign)QA(Sign)
1No. of BMR pages   
2Material Requisition Slip   
3Dispensing Label/ Tag   
4Line Clearance Certificate   
5Quality Control Report (Bulk)   
6In-Process checks (Filling & Sealing)   
7Reconciliation of Packing Material   
8Yield Reconciliation at all Stages   
9Quality Control Report (Finished Goods)   
10Specimen of coded PM specimen   
11Finished Goods Transfer Slip   

14.0 BMR REVIEW:

BMR Reviewed By

(Manager-Production)

BMR Reviewed By

(Manager-Quality Assurance )

  

 

 15.0 BATCH RELEASE:

All contents of the batch record have been checked, reviewed & found complying/not complying with the proper requirements. As per in process checks record & data submitted by quality control the product complies/does not comply with specifications . Hence the batch can/cannot be released for sale & distribution.

                                                                                                                       QA Head

(Sign/Date)

 

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About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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