BPR TABLET Jar

BIONIAL HEALTHCARE PVT. LTD. Page No.
D-97,PHASE-7,INDUSTRIAL AREA,MOHALI,PIN-160055
1 of 16
BATCH PACKING RECORD
PRODUCT NAME:
BATCH
BATCH No. MFG. DATE EXP. DATE BPR No.
SIZE
BPR/A/001-00
EFFECTIVE REVIEW REVISION
07/08/2023 06/08/2025 01
DATE DATE No.
1.0 PRODUCT INFORMATION
Brand Name
Product Generic name :
Batch Number :
Batch Size :
Manufacturing Date :
Expiry Date :
M.R.P : Shelf :
Life
Mfg. Lic. No. : 1994-OSP & 2054 B
Packing Specification :
Date of commencement :
Date of completion :
AFTER BATCH COMPLETION:

Checked By(Manager -Production) Signature: Date:
Approved By(Manager -Q.A) Signature: Date:
2.0 CONTENTS OF BPR

S. No. Particulars Checked by Checked
Production by IPQA
1. Set Parameter of Alu Alu, Poly Strip & Blister packing machine & change part
2. Packing Material Requisition Slip
3. Line Clearance of dispensing
4. Weighing Tags
5. General instruction
6. Over printing Details of Packing Material
7. Line Clearance for Batch Coding
8. Specimen of carton
9. Line Clearance for Packing & Packing Instructions
10. Specimen of Foil
11. Testing Requisition Slip of finished Tablets samples
12. In process Sheets of Packing
13. Reconciliation of Packing Material
14. Finish Good Transfer Note
15. Revision History
Prepared By Checked By Approved By

JUNAID DEVENDRA SAHILA
Name
KUMAR
SR.EXECUTIVE MANAGER MANAGER
Designation
PRODUCTION PRODUCTION QA
Signature
Date 07/08/2023 07/08/2023 07/08/2023
Format No.BH/QA/051/F02-00
2 of 16
PRODUCT NAME:
BATCH
SIZE
BPR/A/001-00
07/08/2023 06/08/2025 01
DATE DATE No.
Sign. of Production Chemist Sign. of IPQA Officer

Name
KUMAR
SR.EXECUTIVE MANAGER MANAGER
Designation
PRODUCTION PRODUCTION QA
Signature
Date 07/08/2023 07/08/2023 07/08/2023
3 of 16
PRODUCT NAME:
BATCH
SIZE
BPR/A/001-00
07/08/2023 06/08/2025 01
DATE DATE No.
6.0 PACKING MATERIAL REQUISITION SLIP Brand Name :
Sr. Std. Qty. Qty.
Issued Checked Verified.
No Units Qty. Required Issued Analytical
Ingredient By . By By.
. for 1.0 for _____ Report No.
(Store) (Prod.) (IPQA)
Lac Lac
HDPE Jar Nos. ………

1.
(………..cc) +
2%
Label
Nos.
2. …………….. Tablet ………
5%
Carton Nos. ………
3. ………...…. Tablets +1%
5/7 Ply Shipper Nos.
4.
BOPP Tape Nos.
5.
Requested by Verified by Issued by Received by

Production Head QA Head Store Production Chemist
(Sign/Date) (Sign/Date) (Sign/Date) (Sign/Date)

Name
KUMAR
SR.EXECUTIVE MANAGER- MANAGER-QA
Designation
PRODUCTION PRODUCTION
Signature
Date 07/08/2023 07/08/2023 07/08/2023
4 of 16
PRODUCT NAME:
BATCH
SIZE
BPR/A/001-00
07/08/2023 06/08/2025 01
DATE DATE No.
7.0 DISPENSING PROCESS: Check for line clearance as per SOP No. : BH/QA/031
LINE CLEARANCE FOR DISPENSING
Date: Time:
Previous Product Name: Previous Product Batch No.:
Sr. Check points Checked by Verified Remarks

No. (Production) by (Ok/Not
(✓)or (X) (IPQA) Ok)
(✓)or (X)
Check the cleanliness of the room and ensure
1. that it is free from the remains of the previous
batch.
Ensure that the area is free from previous
2.
product.
Check the temperature & relative humidity of
the area
3.
[I.H. Limit: Temp = NMT 300C, RH=
NMT 70%]
Containers / Poly bags used for dispensing
4.
are clean & bear status labels.
5. Check authorized BPR is available
6. Waste bin should be cleaned
Checked By (Production Chemist) Verified By (IPQA Officer)

Signature & Date Signature & Date
8.0 SPACE FOR WEIGHING TAGS

Name
KUMAR
Designation
Signature
Date 07/08/2023 07/08/2023 07/08/2023
5 of 16
PRODUCT NAME:
BATCH
SIZE
BPR/A/001-00
07/08/2023 06/08/2025 01
DATE DATE No.
Check point Checked By Verified By Remarks
(Production Chemist) (IPQA Officer)
Check the Weighing tags are attached or not.

Name
KUMAR
Designation
Signature
Date 07/08/2023 07/08/2023 07/08/2023
6 of 16
PRODUCT NAME:
BATCH
SIZE
BPR/A/001-00
07/08/2023 06/08/2025 01
DATE DATE No.
9.0 GENERAL INSTRUCTIONS
 Line Clearance to be taken by Production in presence of QA at the start of batches and every day before
start of operation.
 Start up checks to be performed by Production & QA everyday at the start of activity or after any
Breakdown.
 All the Operations must be carried out under strict Environmental Conditions. Temperature Limit
NMT30 and Relative Humidity (RH) NMT50
 Product shall be properly labeled at all stages during the processing.
 Check that the right packaging materials are received from stores & quantities of each item are as per the
standard packaging order.
 Destroyed The Entire Leak Test Sample.
 Wear hand gloves and nose mask during primary packing of batch.
 Do not overwrite in the BPR. If the initial data is wrongly entered, cancel the data by single stroke across
and across the initial with data and write the correct data.
 Receive QC released batch from manufacturing department and counter check the weight.
 Perform in-process check and reconcile the batch and record the same in BPR.
 After completion of batch, transfer the Finished Goods to Finished Goods Store.
 After completion of batch/shift, ensure that the machine is switched off and area is cleaned.
 The persons working in area must follow proper gowning as per the respective SOP.
 Any deviation from the BPR must be done with prior approval of QA.
 In case of any non compliance, stop the operation and report to the officer concerned.
10.0 OVER PRINTING DETAILS OF PACKING MATERIAL

MOTHER BATCH DETAILS
PRODUCT GENERIC NAME :
MOTHER BATCH NUMBER :
Overprinting for foil & cartons
Product Name :
Batch No. : Mfg. license No. : 1994-OSP & 2054-B
Mfg. Date : Exp. Date :
Order qty : M.R.P :

Name
KUMAR
Designation
Signature
Date 07/08/2023 07/08/2023 07/08/2023
7 of 16
PRODUCT NAME:
BATCH
SIZE
BPR/A/001-00
07/08/2023 06/08/2025 01
DATE DATE No.
*(For Batch details refer to Batch Allocation Sheet of BMR)
11.0 CODING PROCESS: Check for Line Clearance as per SOP No. BH/QA/031
LINE CLEARANCE FOR BATCH CODING
Date: Time:
Equipment Name Equipment ID No.
Over printing coding machine BH/PGT/OPR/PCM/01

(✓)or (X)
1. Check the cleanliness of the Area.
Ensure the machine & conveyor belt are neat
2.
& clean.
3. Ensure the area is free from previous product.
the area
4.
[I.H. Limit: Temp.= NMT 300C, RH=
NMT 50%]
Check the proper status labeling on the
5.
machines.
Check proper gowning should be followed in
6.
respective area.
8. Ensure the status label updated
Checked By (Production Chemist) : Verified By (IPQA Officer) :

Signature & Date: Signature & Date:
11.1 EQUIPMENT OPERATION DETAILS :-
Name of Date of Coding time Coding In Actual Done Checked Remarks
Material Coding Rejection Coded by By (Prod.)
From To
Material

Name
KUMAR
Designation
Signature
Date 07/08/2023 07/08/2023 07/08/2023
8 of 16
PRODUCT NAME:
BATCH
SIZE
BPR/A/001-00
07/08/2023 06/08/2025 01
DATE DATE No.
11.2 IN-PROCESS CHECKS OF CARTONS OVERCODING :-
MRP (PER Checked Verified by
Date/Time Product Batch No. Mfg Exp By (Prod.) (IPQA)
………...TAB.)
11.3 SPECIMEN OF CARTON

Name
KUMAR
Designation
Signature
Date 07/08/2023 07/08/2023 07/08/2023
9 of 16
PRODUCT NAME:
BATCH
SIZE
BPR/A/001-00
07/08/2023 06/08/2025 01
DATE DATE No.

Name
KUMAR
Designation
Signature
Date 07/08/2023 07/08/2023 07/08/2023
10 of 16
PRODUCT NAME:
BATCH
SIZE
BPR/A/001-00
07/08/2023 06/08/2025 01
DATE DATE No.
12.0 PACKING: Check for Line Clearance as per SOP No. : BH/QA/031
LINE CLEARANCE FOR PACKING
Date: Time:
Equipment Name Equipment ID No.

(✓)or (X)
Check the cleanliness of the respective
1.
material air lock/Pass box/Area.
Ensure the machine & conveyor belt are neat
2.
& clean.
3. Ensure the area is free from previous product.
the area
4.
[I.H. Limit: Temp.= NMT 300C, RH=
NMT 50%]
Check the differential pressure of the area
5.
[I.H. Limit: NLT 6 Pascal]
Toolkit and other unwanted things should be
6.
removed from the area .
Check proper gowning should be followed in
7.
respective area.
9. Ensure the status label updated

Signature & Date Signature & Date

Name
KUMAR
Designation
Signature
Date 07/08/2023 07/08/2023 07/08/2023
11 of 16
PRODUCT NAME:
BATCH
SIZE
BPR/A/001-00
07/08/2023 06/08/2025 01
DATE DATE No.
S. Packing Instructions Date Time Done Checked Verified

No. From To By By by
(Prod.) (IPQA)
12. Jar Filling:
1 a)Ensure the Jar filling area should be clean before
the start of jar filling.
b)Fill the required no. of tablets according to weight
manually in recommended jar.
c)Put the silica gel in the filled bottle.
d)Tight the jar with lid.
Jar Sealing:
After filling of tablets in jar seal the bottle through
induction sealing machine by tracing the induction
heat bottom on filled bottle cap up to 0.5 to 0.8 sec.
Labeling of Jar:
a)After filling and sealing of the jar transfer the bottle
in secondary packing department.
b)Take the printed label and paste on the jar manually
and packed in corrugated boxes
12. Start Packing as per current packing order with REFER TO IN PROCESS CONTROL SHEET
2 following Instruction
Packing of Jar in Carton:
 Place 1 labeled jar in 1 carton.Each carton is inspected
for clarity and corrections of printed matter.
Packing of cartons in Master Pack:
 Pack _____ cartons (each containing 1 jar ) in one
master pack.
a) Master pack is then closed by another worker, who
checks that correct numbers of cartons packed in
master pack. Master pack is closed using BOPP
adhesive tape.
Packing in Master(without carton ) \
 ______jar is packed in one shrink poly bag,
which is then sealed properly using hand sealing
machine. After sealing, it is then passed through

Name
KUMAR
Designation
Signature
Date 07/08/2023 07/08/2023 07/08/2023
12 of 16
PRODUCT NAME:
BATCH
SIZE
BPR/A/001-00
07/08/2023 06/08/2025 01
DATE DATE No.
Shrink Packing Machine, for shrink packing.
 Master packs are packed with ____ labeled
bottles in a manner(in one layer)
 A corrugated plate is placed above these bottles.
 Again pack _____labeled bottles are packed in a
manner(2nd layer).Master pack is closed using
BOPP adhesive tape
S.No Parameters Limit Frequency
1. Clarity of overprinted matter Should be clean& At the start &after every 60 min.
legible
2. Correctness of overprinted As per printing At the start & after change of roll
matter Instructions
3. Number of tablets per Jar ______ tablets /Jar At the start &after every 60 min.
4. No. of strips per carton/Catch ______ tablets /Jar At the start &after every 60 min.
Cover
12. .FINISHED PRODUCT TESTING & RELEASE :

3 *On completion of batch packing, send ‘Testing Requisition Slip’ to IPQA asking to withdraw the control
sample & sample of finished product for complete analysis as per ‘Finished Product specifications’.
*On getting the Release order from QC, transfer the finished product to finished goods store along with
‘Transfer ticket’.
*Send the BPR to Q.A. department for review & batch is released for dispatch after getting approval from
QA Manager.
12.4 SPECIMEN OF Label

Name
KUMAR
Designation
Signature
Date 07/08/2023 07/08/2023 07/08/2023
13 of 16
PRODUCT NAME:
BATCH
SIZE
BPR/A/001-00
07/08/2023 06/08/2025 01
DATE DATE No.
10.0 IN PROCESS SHEET OF LABELLING & PACKING

10.1 INPROCESS CHECKS DURING LABELLING
Sr. Date Time No. of Parameters Checked Checked
No Bottles Label Batch Mfg. Exp. M.R.P Dose Printed Matter By
. taken for Pasting No. Date Date Cap (OK or Not (Prod.)
checking on OK)
bottles
10.2 Check for Clarity & Correctness of Printed/Overprinted Matter of carton

S. Date Time No. of Parameters Checked Checked
No. Bottles Batch No. Mfg. Exp. M.R.P Printed Matter By
taken for Date Date (OK or Not OK) (Prod.)
checking

Name
KUMAR
Designation
Signature
Date 07/08/2023 07/08/2023 07/08/2023
14 of 16
PRODUCT NAME:
BATCH
SIZE
BPR/A/001-00
07/08/2023 06/08/2025 01
DATE DATE No.
*Note: Additional pages to be issued as per batch size at the time of BMR issuance.
JAR PACKING
NO. OF TABLETS _________TABLETS AVERAGE WEIGHT OF
FILLED IN JAR TABLET
AVG. WEIGHT OF WEIGHT OF ______NO. OF
EMPTY JAR TABLETS
WEIGHT OF FILLED JAR LIMIT OF FILLED JAR ________to ______gm(+
____%)
S. NO. DATE TIME WEIGHT OF FILLED PACK PRINTED MATTER CHECKED RE
JAR(gm) SIZE (OK OR NOT) BY
13.4 Shipper Weighing Record: - Weighing balance ID:

G. Wt. Weighed G. Wt. Weighed G. Wt.
S. No. S. No. S. No. Weighed By
(Kg) By (Kg) By (Kg)
1. 13. 25.
2. 14. 26.
3. 15. 27.
4. 16. 28.
5. 17. 29.
6. 18. 30.
7. 19. 31.
8. 20. 32.
9. 21. 33.

Name
KUMAR
Designation
Signature
Date 07/08/2023 07/08/2023 07/08/2023
15 of 16
PRODUCT NAME:
BATCH
SIZE
BPR/A/001-00
07/08/2023 06/08/2025 01
DATE DATE No.
10. 22. 34.
11. 23. 35.
12. 24. 36.
Min. Wt. Observed: ____________kg Max. Wt. Observed:_____________kg
14.0 PACKING GOODS DETAILS :-

DATE Control sample Stability Finish sample No. of boxes packed PACK
Sample transferred to SIZE CHECKED
Finished Goods Store BY
*Enter these details in the yield statement attached in BMR
15. 0 RECONCILIATION OF PACKING MATERIAL:-

S. Name of Material Requisitioned Received Used Returned Quantity Destroyed Checked
No. Qty. Qty. Qty. Qty. destroyed by By
1 HDPE Jar
(………..cc)
2 Label
…………….. Tablet
3 Carton
………...…. Tablets
16.0 FINISHED PRODUCT TRANSFER RELEASE NOTE:-

Date T.T No. Total No. of Qty. of boxes Total No. Qty. of Boxes In Total No. Of Boxes
full shipper in one of loose Loose C. Box. To Ready For
shipper shipper Dispatch
Packed batch is release/ not release for sale.

Name
KUMAR
Designation
Signature
Date 07/08/2023 07/08/2023 07/08/2023
16 of 16
PRODUCT NAME:
BATCH
SIZE
BPR/A/001-00
07/08/2023 06/08/2025 01
DATE DATE No.
Production head QA head
(Sign & Date) (Sign & Date)
17.0 REVISION HISTORY

Revision No. Change Control No. Reason for Revision
00 NA First Issuance
01 CC/QA/23-005 To Revise the BMR/BPR for proper execution and documentation
purpose & to Revise the format No.

Name
KUMAR
Designation
Signature
Date 07/08/2023 07/08/2023 07/08/2023

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BIONIAL HEALTHCARE PVT. LTD. Page No.

AFTER BATCH COMPLETION:

2.0 CONTENTS OF BPR

Prepared By Checked By Approved By

Prepared By Checked By Approved By

HDPE Jar Nos. ………

Requested by Verified by Issued by Received by

Prepared By Checked By Approved By

Sr. Check points Checked by Verified Remarks

6. Waste bin should be cleaned

Checked By (Production Chemist) Verified By (IPQA Officer)

8.0 SPACE FOR WEIGHING TAGS

Prepared By Checked By Approved By

10.0 OVER PRINTING DETAILS OF PACKING MATERIAL

Prepared By Checked By Approved By

Sr. Check points Checked by Verified Remarks

Checked By (Production Chemist) : Verified By (IPQA Officer) :

Prepared By Checked By Approved By

11.3 SPECIMEN OF CARTON

Prepared By Checked By Approved By

Prepared By Checked By Approved By

Sr. Check points Checked by Verified Remarks

9. Ensure the status label updated

Checked By (Production Chemist) Verified By (IPQA Officer)

Prepared By Checked By Approved By

S. Packing Instructions Date Time Done Checked Verified

Prepared By Checked By Approved By

12. .FINISHED PRODUCT TESTING & RELEASE :

Prepared By Checked By Approved By

10.0 IN PROCESS SHEET OF LABELLING & PACKING

10.2 Check for Clarity & Correctness of Printed/Overprinted Matter of carton

Prepared By Checked By Approved By

13.4 Shipper Weighing Record: - Weighing balance ID:

Prepared By Checked By Approved By

Min. Wt. Observed: ____________kg Max. Wt. Observed:_____________kg

Checked By (Production Chemist) Verified By (IPQA Officer)

14.0 PACKING GOODS DETAILS :-

*Enter these details in the yield statement attached in BMR

15. 0 RECONCILIATION OF PACKING MATERIAL:-

16.0 FINISHED PRODUCT TRANSFER RELEASE NOTE:-

Packed batch is release/ not release for sale.

Prepared By Checked By Approved By

17.0 REVISION HISTORY

Prepared By Checked By Approved By

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Min. Wt. Observed: kg Max. Wt. Observed:_kg