Ibuspan 200mgtablets BPR

BATCH PACKAGING RECORD
Title: Ibuspan BP (Ibuprofen BP 200mg) Tablets BPR No. COS/BPR /026

Revision No. 01 Supersedes. 00
Department. Production Page No. 1 of 46
Batch Size 500 000 250 000
1 000 000 2 000 000
BRAND NAME: Ibuspan Tablets
Generic Name: Ibuprofen

Label Claim: Ibuprofen BP 200mg
Manufactured By: COSPHARM PHARMACEUTICALS, Stand 12896, Madokero Industrial Area, Harare, Zimbabwe
Registration Number: 2003/3.1/4155

Shelf Life: 36 months
Product Code: 30026
Pack sizes: 10s
30s
100s
1000s
Batch size
Batch No:
Date of Manufacture:
Date of Packaging:
Expiry date:
BPR Issued By QA: Signature: Date
Batch Packing Completed on:
Executed Batch Packaging Record Reviewed By:
Production Pharmacist Date: Signature:
QMS Pharmacist Sign: Date: Signature:
QA Pharmacist Sign: Date: Signature:
QA RELEASE STAMP
Prepared By Reviewed By Approved by

Signature
Date 27/11/2023 27/11/2023 27/11/2023
Designation Production Pharmacist RNDTT Officer QA Pharmacist
COS/QAD/015/F02-01

Batch Size 500 000 250 000
1 000 000 2 000 000
1. ABBREVIATIONS
ABBREVIATION FULL FORM ABBREVIATION FULL FORM

01. BMR Batch manufacturing 21. Avg. wt. Average Weight
record
02. Std Standard 22. Temp. Temperature
03. Mfg. Date Manufacturing Date 23 RH Relative Humidity
04. Exp. Date Expiry Date 24 Max Maximum
05. SS Stainless steel 25 Min. Minimum
06. QA Quality Assurance 26 Wt. Weight
07. Reg. No. Registration Number 27 NMT Not more than
08. RM. Stores Raw material stores 28 min Minute(s)
09. QMS Quality Management 29 hrs Hours

Systems
10. Kg Kilograms 30 Qty. Quantity
11. L Litres 31 Spec. Specification
12. ml Millilitres 32 NLT Not Less Than
13. BOPP Biaxially oriented 33 g Grams

polypropylene
14. QC Quality control 34 mg Milligram
15. N/A Not Applicable 35 BCP Blister packing &

printing
16. FP Finished Product 36 NFD Non-fill Detection
17. BP British Pharmacopeia 37 PA Pascals
18. SOP Standard Operating 38 IPQA In-process quality

Procedure Assurance

Signature
Date 27/11/2023 27/11/2023 27/11/2023
COS/QAD/015/F02-01

Batch Size 500 000 250 000
1 000 000 2 000 000
ABBREVIATION FULL FORM ABBREVIATION FULL FORM

19. API Active 39 mm Millimetre mercury
Pharmaceutical
ingredients
20. S seconds 40 UoM Unit of measurement
21. Qty Quantity 41 AR. Analytical report
2. DISPENSING
2.1 Line clearance certificate for area and equipment:
Area Dispensing room Equipment Weighing

Balance
Area cleaned by Equipment No.
Checked By Equipment cleaned by
Previous product Batch No.
Checked By (Packing Supervisor)
Sign & Date
Line clearance Given By (IPQA):
Sign & Date
2.2 Dispensing Instructions
No Step Read by Supervisor

Operator Check

Signature
Date 27/11/2023 27/11/2023 27/11/2023
COS/QAD/015/F02-01

Batch Size 500 000 250 000
1 000 000 2 000 000
General Dispensing Instructions

1.
Check the following before sending to dispensary;
i) Sticker from the sending unit
ii) Cospharm release sticker
iii) Weight
__________________kg
iv) Material name
v) Manufacturer from approved vendor list
vi) All logbooks have been updated
Weigh and dispense materials as per SOP: COS/SD/003
COSPHARM PHARMACEUTICALS
PRODUCT: Ibuspan 200mg Tablets DATE: BATCH NO:
ERP RAW MATERIAL UoM STD QTY ACTUAL QTY AR No WEIGHED CHECKED ADDED
CODE WEIGHED BY BY TO
BATCH BY
10069 Bulk Ibuspan 200mg kg
tablets
2.3 FORMULA PAGE
2.4 DISPENSING OF STARTING MATERIAL
2.4.1 LINE CLEARANCE CHECKLIST

Room Name: Dispensary Booth
Date ___________________________ Time_________________________
Previous Product: ________________ Batch. No._____________________

Description Observation Done by Verified By
(YES/NO) IPQA
1 Room status label has been fully updated
2 All materials used for the previous product have

Signature
Date 27/11/2023 27/11/2023 27/11/2023
COS/QAD/015/F02-01

Batch Size 500 000 250 000
1 000 000 2 000 000
2.4.1 LINE CLEARANCE CHECKLIST

Room Name: Dispensary Booth
Date ___________________________ Time_________________________

Description Observation Done by Verified By
(YES/NO) IPQA
been removed
3 Log books have been updated
4 Dispensary cubicle is clean and ready for use
5 Dispensing booth is clean and ready for use
6 The balance is clean and ready for use
7 Balances are properly levelled, calibrated &
recorded in log books
8 Pressure Differentials for Dispensing booth are
within the required specifications:
Pre-Filter -4.00mm – -7.00mm
MU Filter 5.00mm – 8.00mm
HEPA Filter 7.00mm – 22.00mm
Dynamic Passbox 7.00mm- 20mm
9 Dispensing accessories are clean and ready for use
10 Dynamic pass boxes have been cleaned and
disinfected
11 Materials to be dispensed carry
"APPROVED" labels
2.4.2 ENVIRONMENTAL MONITORING

Room Name: Dispensing Booth
Date ______________________ Time___________________
Previous Product: ____________________ Batch No: _______________
DATE TIME PARAMETERS AND LIMITS

Room Temp RH (35% - Pressure Checked By: Verified By: IPQA
(20-27°C) 75%RH) Differential Dispensary
Reading (0.6-2.4 Operator
mmH2O)

Signature
Date 27/11/2023 27/11/2023 27/11/2023
COS/QAD/015/F02-01

Batch Size 500 000 250 000
1 000 000 2 000 000
2.4.3 WEIGHING OF STARTING MATERIALS
Dispensary Operator Name:

Starting Time: _______________ Finishing Time: _______________
Date: ________________ Date: _______________
3. ISSUANCE OF PACKAGING MATERIAL
3.1 ISSUANCE OF PACKAGING MATERIAL FOR JAR PACKING

Item Packaging UOM AR No. Std Qty/ Actual Actual Issued Date
code Material % of required Issued by
theoretical Qty.for Qty
yield theoretical Net
yield Wt/No
20043 1000s Nos. 100
White
HDPE pill
bottles
20044 1000s Nos. 100
White
HDPE
bottle
Signature
Date 27/11/2023 27/11/2023 27/11/2023
COS/QAD/015/F02-01

Batch Size 500 000 250 000
1 000 000 2 000 000
yield Wt/No
closures
20097 Ibuspan Nos. 100
200mg
sticker
label
20096 Ibuspan Nos. 100
200mg
Leaflet
20022 Shrink Nos. 100
wrap
Signature: Signature: Signature:
Date: Date: Date:

(IPQA)
(Stores (Production)
Department)
3.2 ISSUANCE OF PACKAGING MATERIAL FOR BLISTER PACKING

yield Wt/No
20095 Ibuspan Kg 100
200mg
Printed Alu
foil

Signature
Date 27/11/2023 27/11/2023 27/11/2023
COS/QAD/015/F02-01

Batch Size 500 000 250 000
1 000 000 2 000 000
yield Wt/No
20051 Plain PVC Kg 100
Foil
20098
Printed Nos. 100
Carton
200mg
(3x10’s)
20099
Printed Nos. 100
Carton
200mg
(3x10’s)
20096
Ibuspan Nos. 100
200mg
Leaflet
20091
Cello tape Nos. 100
20093
Corrugated Nos. 100
box
20092 Duct tape Nos. 100
Date: Date: Date:

(IPQA)
(Stores Department) (Production)
4. EXCESS MATERIAL ISSUANCE MATERIAL RECORD
4.1 EXCESS MATERIAL ISSUANCE MATERIAL RECORD FOR JAR PACKING

Signature
Date 27/11/2023 27/11/2023 27/11/2023
COS/QAD/015/F02-01

Batch Size 500 000 250 000
1 000 000 2 000 000
Item Packaging UOM AR No. Actual Actual Issued by Date

code Material required Issued Qty
Qty.for Net Wt/No
batch
20043 1000s Nos.
White
HDPE pill
bottles
20044 1000s Nos.
White
HDPE
bottle
closures
20097 Ibuspan Nos.
200mg
sticker
label
20096 Ibuspan Nos.
200mg
Leaflet
20022 Shrink Nos.
wrap
Date: Date: Date:

(IPQA)
4.2 EXCESS MATERIAL ISSUANCE RECORD FOR BLISTER PACKING

Signature
Date 27/11/2023 27/11/2023 27/11/2023
COS/QAD/015/F02-01

Batch Size 500 000 250 000
1 000 000 2 000 000
Item Packaging UOM AR No. Actual Actual Issued by Date

code Material required Issued Qty
Qty.for Net Wt/No
batch
20095 Ibuspan Kg
200mg
Printed Alu
Foil
20051 Plain PVC Kg
Foil
20098 Printed Nos.
Carton
200mg
(3x10’s)
20099 Printed Nos.
Carton
200mg
(3x10’s)
20096 Ibuspan Nos.
200mg
Leaflet
20091 Cello tape Nos.
20093 Corrugated Nos.

box
20092 Duct tape Nos.
Date: Date: Date:

(IPQA)
Justification (for additional material):
__________________________________________________________________________________

Signature
Date 27/11/2023 27/11/2023 27/11/2023
COS/QAD/015/F02-01

Batch Size 500 000 250 000
1 000 000 2 000 000
__________________________________________________________________________________
__________________________________________________________________________________
__________________________________________________________________________________
__________________________________________________________________________________
_________________________________________________________________________
5. LIST OF EQUIPMENT AND UTILITIES USED
No Equipment name Operational Equipmen Qualification

SOP Number t ID / Calibration
status
1. Automatic coding and labelling COS/PRD/047 PDP-05D

machine
2. Tablet counting machine COS/SD/051 PDP-07
3. Manufacturing scale COS/SD/015 PDM-03
4. Dispensary Booth COS/SD/014 PDM-14
5. Blister Packing machine COS/PRD/022 PDP-01
6. Weighing scale COS/SD/015 PDM-25
7. HVAC COS/ENG/034 ENG-15
8. Three way Dynamic Passbox COS/SD/013 PDM-27

Signature
Date 27/11/2023 27/11/2023 27/11/2023
COS/QAD/015/F02-01

Batch Size 500 000 250 000
1 000 000 2 000 000
6. PACKAGING
Printed material confirmation

Ibuspan tablets BP 200mg’s Label identity check:
Product Strength
Batch No. Pack Size
Manufacturing date
Expiry date
Reg. No. Category
Ibuspan tablets BP 200mg’s Package insert identity check:
Product Reg. No.
Category Principal
Ibuspan tablets BP 200mg’s Product carton identity check:
Product Reg. No.
Strength Manufacturing date
Pack Size Expiry date
Ibuspan tablets BP 200mg’s Printed Aluminium foil identity check:
Product Strength
Batch No. Pack Size
Manufacturing date
Expiry date

Signature
Date 27/11/2023 27/11/2023 27/11/2023
COS/QAD/015/F02-01

Batch Size 500 000 250 000
1 000 000 2 000 000
Reg. No. Category
Printed material confirmation done by Production Pharmacist:
___________Date ___________ Time _____
Printed material Verified by IPQA Pharmacist:
____________ Date ___________ Time _____

Signature
Date 27/11/2023 27/11/2023 27/11/2023
COS/QAD/015/F02-01

Batch Size 500 000 250 000
1 000 000 2 000 000
6.1 LINE CLEARANCE CHECKLIST:

Line clearance checks to be done initially and when sudden power failure occurs.
Room Name: BLISTER PACKING CUBICLE

Date ___________________________ Time_________________________

Description Observation Checked by Verified By
(YES/NO) Packaging IPQA
Supervisor
6.1.1 Area is clean and ready for use
6.1.2 All materials, documents of the previous
product / batch have been removed from
area
6.1.3 Equipment in the cubicle is clean
6.1.4 Area underneath the equipment, pallets
and scales is clean
6.1.5 Relevant status labels for the proceeding
batch have been affixed.
6.1.6 Personnel is wearing protective clothing
i.e., Gloves, coveralls, hairnets, safety
shoes.
6.1.7 Bulk material has been released for
packing.
6.1.8 All logbooks have been updated.
6.1.9 Product Remnants.
6.1.10 Over coding details on Blister are correct
6.1.11 Over coding details on inner carton are
correct
6.2 ENVIRONMENTAL MONITORING

Signature
Date 27/11/2023 27/11/2023 27/11/2023
COS/QAD/015/F02-01

Batch Size 500 000 250 000
1 000 000 2 000 000
Room Name: BLISTER PACKING CUBICLE

Date ______________________ Time___________________

Room Temp RH (35%- Pressure Differential Checked By: Verified By: IPQA
(20-27°C) 75%RH) Reading (0.6-2.4mm
H2O)

Signature
Date 27/11/2023 27/11/2023 27/11/2023
COS/QAD/015/F02-01

Batch Size 500 000 250 000
1 000 000 2 000 000
6.3 PACKAGING INSTRUCTIONS

No Step Read by Supervisor IPQA
Operator Check Check
1.
General Packaging Instructions
1. Ensure that the cubicle and equipment status labels have been
updated.
2. All materials used to process the previous batch should be removed
and line clearance certificate to be obtained from IPQA before starting
any activity.
3. Transfer the dispensed, QC Released Tablets to the Primary Packing
Cubicle.
Blister packing:
4. Pack each blister with 10 tablets using a printed Alu Foil and Plain
PVC foil on the Blister Packing Machine.
5. Operate blister packing machine as per SOP COS/PRD/022. The
blister should be duly overprinted with the respective batch legend.
6. Blister sealing leak test should be performed periodically to monitor
the sealing.
7. Each Blister should be visually inspected in-order to reject the
defective ones.
8. 3 Inspected Blisters should be packed inside each carton for 30s
tablets and 10 inspected Blisters should be packed inside each
carton for 100s tablets. Insert a leaflet in each individual carton.
9. The carton should be duly overprinted with the respective batch
legend.
10. Attach the appropriate shipper sticker with coding details to the
shippers.
11. Each shipper should be sealed using a printed DUCT tape with the
help of duct tape dispenser in H-Type on top and bottom
Jar packing:
12. Using a Tablet counting machine, set the machine to fill the
required number of tablets.
13. Perform pre-filling checks as per pre-filling table below.
14. Fill the rest of the required quantity of tablets in the specified HDPE
containers using a tablet-counting machine.
15. Check the tablets for foreign particles during the filling.
16. Place the leaflet on to the container by use of a rubber band.
Signature
Date 27/11/2023 27/11/2023 27/11/2023
COS/QAD/015/F02-01

Batch Size 500 000 250 000
1 000 000 2 000 000
17. Label the containers either manually or by use of an automatic

labelling machine.
18. Shrink-wrap the containers in sixes for 1000s.
19. After completion of the Batch packing, intimate IPQA department
through the transfer ticket.
20. Complete the BPR for reconciliation of the batch after that
transfer the packed shippers to the Finish Goods Quarantine.
Pre- filling checks(Perform for the first 3 containers)
PRODUCT: DATE:
BATCH No. NAME OF IN-PROCESS CHECKERS IPQA :
BATCH SIZE: OPERATOR:
PACK SIZE: TIME
Container Number of tablets counted Checked by IPQA

no.
1.
2.
3.
Operator
signature
and Date

Signature
Date 27/11/2023 27/11/2023 27/11/2023
COS/QAD/015/F02-01

Batch Size 500 000 250 000
1 000 000 2 000 000
IN-PROCESS CHECKS
In-process check by production and QA at initial stage, every 30 mins and after 1 hour
interchangeably. Fill quantity checked on hourly intervals
In process Date
checks
Time
1. Temp.(̊C) (20-27°C)
2. RH (%)(35%-75%RH)
3. Fill quantity
4. Tab. with foreign

/black particles
5. Sealing Roller
Temperature (̊C)
6. Foil shifting
7. Batch detail on foil
8. No. of Tabs/Blister
9. Proper cutting of
Blister
10. Leak test (30 mins)
Reviewed by (IPQA)

Signature
Date 27/11/2023 27/11/2023 27/11/2023
COS/QAD/015/F02-01

Batch Size 500 000 250 000
1 000 000 2 000 000
In process Date
checks
Time
11. Temp.(̊C) (20-27°C)
12. RH (%)(35%-75%RH)
13. Fill quantity

/black particles
15. Sealing Roller
Temperature (̊C)
16. Foil shifting

Blister
Reviewed by (IPQA)

Signature
Date 27/11/2023 27/11/2023 27/11/2023
COS/QAD/015/F02-01

Batch Size 500 000 250 000
1 000 000 2 000 000
In process Date
checks
Time
21. Temp.(̊C) (20-27°C)
22. RH (%)(35%-75%RH)
23. Fill quantity

/black particles
25. Sealing Roller
Temperature (̊C)
26. Foil shifting

Blister
Reviewed by (IPQA)

Signature
Date 27/11/2023 27/11/2023 27/11/2023
COS/QAD/015/F02-01

Batch Size 500 000 250 000
1 000 000 2 000 000
In process Date
checks
Time
31. Temp.(̊C) (20-27°C)
32. RH (%)(35%-75%RH)
33. Fill quantity

/black particles
35. Sealing Roller
Temperature (̊C)
36. Foil shifting

Blister
Reviewed by (IPQA)

Signature
Date 27/11/2023 27/11/2023 27/11/2023
COS/QAD/015/F02-01

Batch Size 500 000 250 000
1 000 000 2 000 000
7.0 SECONDARY PACKING
7.1 LINE CLEARANCE CHECKLIST

7.2 ENVIRONMENTAL MONITORING
Room Name: Secondary Packing Room
Date ___________________________ Time_________________________

Description Observation Checked by Verified By
(YES/NO) Packaging IPQA
Supervisor
7.1.1 Labels, cartons, shipper, leaflets used for the
previous batch/ product have been removed
from the area.
7.1.2 All status labels of previous batch/ product/
other labels used for the area have been
removed
7.1.3 BPR or any other documents related to the
previous batch/ product remnants have been
cleared
7.1.4 Labelling machine is clean & ready for use
7.1.5 Conveyor belt is clean & ready for use
7.1.6 Shrinkage Machine is clean & ready for use
7.1.7 All Logbooks have been filled
7.1.8 Area is clean and ready for use.
7.1.9 Relevant status labels affixed for the proceeding
batch
Room Name: Secondary packing cubicle

Date ______________________ Time___________________
Signature
Date 27/11/2023 27/11/2023 27/11/2023
COS/QAD/015/F02-01

Batch Size 500 000 250 000
1 000 000 2 000 000

Room Temp RH (35%- Pressure Differential Checked Verified
(20-27°C) 75%RH) Reading (0.6-2.4mm By: By: IPQA
H2O)
7.3 LABEL PRINTING/ OVERPRINTING DETAILS
Parameters Details Checked By (Prod) Verified By (IPQA)
Name of the product
Registration. No.
Batch No
Manufacturing date
Expiry date
Specimen checked by
7.4 CARTON PRINTING/ OVERPRINTING DETAILS
Parameters Details Checked By (Prod) Verified By (IPQA)
Name of the product
Registration. No.
Batch No
Manufacturing date
Expiry date

Signature
Date 27/11/2023 27/11/2023 27/11/2023
COS/QAD/015/F02-01

Batch Size 500 000 250 000
1 000 000 2 000 000
Specimen checked by
SAMPLE OF CODING, BLISTER, LEAFLET AND LABEL USED
(attach the sample label here)

Signature
Date 27/11/2023 27/11/2023 27/11/2023
COS/QAD/015/F02-01

Batch Size 500 000 250 000
1 000 000 2 000 000
Checked By Production Pharmacist: _________________ Date_________________________
Checked By IPQA Pharmacist: ___________________ Date_________________________
7.5 PACKING INSTRUCTIONS

No Step Read by Supervisor
Operator Check
1.
General Packaging Instructions
1. Gowning should be follows as per SOP COS/PRD/002.

2. Masks and gloves should be used in the primary packing.
3. Check for the cleanliness of the area and equipment.
4. Check the Temperature, Humidity, and differential Pressure
and record the readings
5. Check that the batch/product has been released by QC for
packing before starting of packaging operations and
transfer to primary packing.
6. Check the status label on the area on the display board
outside the packing cubical.
7. Label the containers either manually or by use of an
automatic labelling machine
8. Shrink-wrap the containers in sixes.
9. 3 Inspected Blisters should be packed inside each carton for
30s tablets and 10 inspected Blisters should be packed
inside each carton for 100s tablets. Insert a leaflet in each
individual carton.
10. The carton should be duly overprinted with the respective
batch legend.
11. Pack the cartons in shippers.

Signature
Date 27/11/2023 27/11/2023 27/11/2023
COS/QAD/015/F02-01

Batch Size 500 000 250 000
1 000 000 2 000 000
12. Attach the appropriate shipper sticker with coding details to

the shippers.
13. Each shipper should be sealed using a printed DUCT tape
with the help of duct tape dispenser in H-Type on top and
bottom
14. After completion of the Batch packing, intimate IPQA
department through the transfer ticket.
15. Line clearance should be done upon shift changes, after
breaks, upon sudden power failures.
16. Line clearance procedure should also be followed in case of
change in stereos or any major breakdown
17. In process controls should be carried out throughout the
packing operations as per relevant BPR and SOP.
7.6 LABEL AND CODING
No Step Done by Supervisor IPQA
Operator Check Check
1. OVERPRINTING
1. Set the overprinting details on the automatic labelling machine
as per SOP number COS/PRD/047.
2. Print the batch details on 2 labels and cartons as per information
given in the BPR, take the specimens and get approval from
packing supervisor and from IPQA.
3. Overprint the rest of the containers and cartons and check for
correctness and legibility of the batch details.
4. In-process, rejection and destruction of rejected cartons shall be
recorded in the appropriate section of the BPR
7.7 OVER CODING DETAILS

Over printing details Label Blister inner Outer Shipper
Carton Carton
Parameter Actual details
1. Registration No.
2. Product Name
3. Batch No.

Signature
Date 27/11/2023 27/11/2023 27/11/2023
COS/QAD/015/F02-01

Batch Size 500 000 250 000
1 000 000 2 000 000
4. Mfg. Date
5. Exp. Date
6. No. of tab per
blister
Packin Signature/Date
g
IPQA Signature/Date
7.8 RECORD OF OVER CODING, INSPECT AND DESTRUCTION.
Particulars Labels Cartons Shipper

1. Quantity Issued
2 Quantity coded
3. Good Inspected quantity
4. Quantity rejected
5. Quantity destroyed
6. Quantity destroyed by
7. Checked by Prod.
(Sign/Date)
8. Verified by
IPQA(Sign/Date)

Signature
Date 27/11/2023 27/11/2023 27/11/2023
COS/QAD/015/F02-01

Batch Size 500 000 250 000
1 000 000 2 000 000
7.9 IN-PROCESS CHECKS
In-process check by production and QA at initial stage, every 30 mins and after 1 hour
interchangeably.
In process Date
checks
Time
1. Temp.(̊C) (20-27°C)
2. RH (%)(35%-75%RH)
3. Correct label on the

containers
4. Correct batch detail on
inner carton
5. No. of blister in one
inner carton
6. Proper insertion of
leaflet in inner carton
7. No. of inner carton in
one outer carton

Signature
Date 27/11/2023 27/11/2023 27/11/2023
COS/QAD/015/F02-01

Batch Size 500 000 250 000
1 000 000 2 000 000
In process Date
checks
tuck in flaps
9. Clear coding details
10. Batch details on

shipper
11. Proper pasting of tape
Reviewed by (IPQA)
In process Date
checks
Time
12. Temp.(̊C) (20-27°C)
13. RH (%)(35%-75%RH)

containers
inner carton
inner carton
one outer carton
tuck in flaps

Signature
Date 27/11/2023 27/11/2023 27/11/2023
COS/QAD/015/F02-01

Batch Size 500 000 250 000
1 000 000 2 000 000
In process Date
checks
shipper
Reviewed by (IPQA)
In process Date
checks
Time
23. Temp.(̊C) (20-27°C)
24. RH (%)(35%-75%RH)

containers
inner carton
inner carton
one outer carton
tuck in flaps
Signature
Date 27/11/2023 27/11/2023 27/11/2023
COS/QAD/015/F02-01

Batch Size 500 000 250 000
1 000 000 2 000 000
In process Date
checks

shipper
Reviewed by (IPQA)
In process Date
checks
Time
34. Temp.(̊C) (20-27°C)
35. RH (%)(35%-75%RH)

containers
inner carton
inner carton
one outer carton
Signature
Date 27/11/2023 27/11/2023 27/11/2023
COS/QAD/015/F02-01

Batch Size 500 000 250 000
1 000 000 2 000 000
In process Date
checks
tuck in flaps

shipper
Reviewed by (IPQA)
QUANTITY OF Q.C RETENTION SAMPLE(S) TAKEN: UNITS
QUANTITY OF Q.C STABILITY SAMPLE(S) TAKEN: UNITS
QUANTITY OF Q.C ANALYSIS SAMPLE(S) TAKEN: UNITS
QUANTITY OF Q.C VALIDATION SAMPLE(S) TAKEN: UNITS
ISSUED TO Q.C: DATE: TIME:
CHECKED BY SUPERVISOR: DATE: TIME
8. DE-FOILING INSTRUCTIONS
STEP (Refer to SOP COS/SD/041) Read by Supervisor

operator check
8.1 Collect all tablets to be de-blistered into a clean polybag.
8.2 Put them on a stainless-steel table.

8.3 Inspect the de-blistered tablet and remove all defective ones.
8.4 Call the pharmacist to check the good selected de-foiled tablets.
8.5 Call IPQA to check and verify the good de-foiled tablets.
8.6 Take the approved de-foiled tablets to the blister machine.

Signature
Date 27/11/2023 27/11/2023 27/11/2023
COS/QAD/015/F02-01

Batch Size 500 000 250 000
1 000 000 2 000 000
9. LINE CLOSING
Packing completed Time: Time: Time:
Date: Date: Date:
Checked by Checked by Checked by IPQA

Supervisor Production
Pharmacist
The bulk material used/excess was removed from

the area.

Signature
Date 27/11/2023 27/11/2023 27/11/2023
COS/QAD/015/F02-01

Batch Size 500 000 250 000
1 000 000 2 000 000
Unused reusable packaging components returned to

stores
Rejects removed, counted and sent for destruction

by the production pharmacist
All rejected printed cartons destroyed by the
production pharmacist
All equipment has been cleaned
Line clearance has been checked by IPQA

Signature
Date 27/11/2023 27/11/2023 27/11/2023
COS/QAD/015/F02-01

Batch Size 500 000 250 000
1 000 000 2 000 000
9.1 BATCH RECONCILIATION
Pack Size
Batch Size
Actual Nett Bulk wt / vol. Issued to packing

hall
Expected number of units for the pack size

from the issued bulk
Average tablet weight
COMMENTS
Theoratical yield F 100% of

issued bulk
________units
Standard yield 98% of issued
bulk ________units
Actual Yield
________units
QC Samples, retention, QA and other units
Transferred yield
Comment

Signature
Date 27/11/2023 27/11/2023 27/11/2023
COS/QAD/015/F02-01

Batch Size 500 000 250 000
1 000 000 2 000 000
Actual Yield = Transferred yield =
% Yield on Theoretical = Actual Yield x 100 =
Theoretical yield
% Variance = 100 – (Transferred yield + Accounted Loss) x 100 =
Theoretical packed yield

Signature
Date 27/11/2023 27/11/2023 27/11/2023
COS/QAD/015/F02-01

Batch Size 500 000 250 000
1 000 000 2 000 000
COMMENTS BY PRODUCTION PHARMACIST IF YIELD IS ABOVE 102% OR BELOW 95%
9.2 PACKAGING MATERIALS RECONCILIATION

Material White White PVC Printe Cartons Leaflet Labels DUCT Tape S
HDPE closures Foil d Foil
bottles
1. Std. Qty
2. Quantity
Issued
3. Extra Qty.
issued
4. Qty.used

Signature
Date 27/11/2023 27/11/2023 27/11/2023
COS/QAD/015/F02-01

Batch Size 500 000 250 000
1 000 000 2 000 000
Material White White PVC Printe Cartons Leaflet Labels DUCT Tape S
HDPE closures Foil d Foil
bottles
5. Qty. returned
6. Qty destroyed
after coding
7. Qty destroyed
after pkg
8. Total Qty
destroyed
9. Qty destroyed
by
10. Checked by
Prod.
(Sign/Date
11. Verified by
IPQA
(sign/date
9.3 REASON FOR VARIANCES
TOTAL VARIANCIES (See table above) REASON FOR VARIANCE
Variance Percentage
(units)
White HDPE

Signature
Date 27/11/2023 27/11/2023 27/11/2023
COS/QAD/015/F02-01

Batch Size 500 000 250 000
1 000 000 2 000 000
bottles
White closures
Leaflet
Printed Alu foil
Plain PVC foil
Carton
Duct tape
Cello tape
Shippers
Shrink wrap
All packaging materials should be fully accounted for i.e. variance should be nil (zero). Product
should be placed on HOLD/QUARANTINE until all packaging material has been satisfactorily
accounted for.
RECONCILIATION BY PACKAGING SUPERVISOR: _______________ DATE; _________
CHECKED BY IPQA INSPECTOR: ____________ DATE: ___________
RECONCILIATION CHECKED AND APPROVED BY:
Production Pharmacist : ___________________ Date ___________________
10. BATCH DIFFICULTIES

Signature
Date 27/11/2023 27/11/2023 27/11/2023
COS/QAD/015/F02-01

Batch Size 500 000 250 000
1 000 000 2 000 000
BATCH DIFFICULTIES / DEVIATION RECORD SHEET
PRODUCT: _____________________________ BATCH NUMBER: _____________________________
APPROVAL
STAG DETAILS OF DEVIATION / DIFFICULTIES SIGNATURES

E
Production QA
Pharmacist Pharmacist
11. LINE ALLOCATION

Signature
Date 27/11/2023 27/11/2023 27/11/2023
COS/QAD/015/F02-01

Batch Size 500 000 250 000
1 000 000 2 000 000
Parameter Name of Operators
CLEANING
Blister packing room
Secondary Packing room
Labelling and coding machine
PROCESSES
Dispensing
Blistering
Jar Filling
Visual inspection of filled containers
leafleting added by
Cartoning done by
Carton locking done by
Shrink wrapping/Shippering Done

by
Verified by Production Pharmacist

Signature
Date 27/11/2023 27/11/2023 27/11/2023
COS/QAD/015/F02-01

Batch Size 500 000 250 000
1 000 000 2 000 000
12. PROCESS TIMES
Standard time
Operation Operators Start Finish Effective

Process Time
Date Time Date Time Man-
(Description) hours
Cleaning
Blister packing
cubicle
Secondary
Packing room
Packing Process
Filling
Blistering
Insert addition
Cartoning and
insert addition
Shrink
wrapping/
Shippering
Physical Analysis

Signature
Date 27/11/2023 27/11/2023 27/11/2023
COS/QAD/015/F02-01

Batch Size 500 000 250 000
1 000 000 2 000 000
13. CHANGE HISTORY
Revision No. Effective Details of Revision Change Control No. Reason For Revision
Date
00 11/05/2022 Changing the humidity and The ranges in use

temperature specification CNF/81/2023 were incorrect.
ranges as follows;
i. Humidity 45 – 65% to
35% -75%
ii. Temperature 23- 27°C
to 20-27°

Signature
Date 27/11/2023 27/11/2023 27/11/2023
COS/QAD/015/F02-01

Batch Size 500 000 250 000
1 000 000 2 000 000
14. BATCH RELEASE FORM
SECTION PARAMETER SIGNATURE:

QA
Pharmacist
A BPR from sending unit reviewed
Bulk from approved SU used
All materials appropriately issued for packaging after QC

release
Line clearance prior to packaging carried out.
Every step in the BPR was documented
All in-process results have been recorded in the BPR.
Line opening and closing procedures observed.
Deviations (if any) have been recorded on the BPR.
Yield properly calculated and commented on where

applicable
BPR has been reviewed and closed by the Pharmacist
Finished product passed physical, chemical and

microbiology analysis
B PACKED PRODUCT EVALUATION
Pack size
Container; type
Fill quantity

Signature
Date 27/11/2023 27/11/2023 27/11/2023
COS/QAD/015/F02-01

Batch Size 500 000 250 000
1 000 000 2 000 000
Label; registration number and sticking well
Distribution category
Package insert (where applicable)
C Quantity Released for distribution
D Quantity retained as samples
COMMENT (S)
_________________________________________________
Q.A STAMP &SIGNATURE
DISPATCH ADVICE
(FOR THE USE OF QA ONLY)
Product: ________________ Batch No: ____________________
Qty Released: _____________ A.R.No: ____________________
Released Date: _________________
The BPR has been reviewed and the above batch is released for SALE/PS
Signature of QA Pharmacist/Designee: Date:

Signature
Date 27/11/2023 27/11/2023 27/11/2023
COS/QAD/015/F02-01

Batch Size 500 000 250 000
1 000 000 2 000 000
QA release stamp

Signature
Date 27/11/2023 27/11/2023 27/11/2023
COS/QAD/015/F02-01

Ibuspan 200mgtablets BPR

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Ibuspan 200mgtablets BPR

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BATCH PACKAGING RECORD

Title: Ibuspan BP (Ibuprofen BP 200mg) Tablets BPR No. COS/BPR /026

BRAND NAME: Ibuspan Tablets

Generic Name: Ibuprofen

Registration Number: 2003/3.1/4155

Prepared By Reviewed By Approved by

Title: Ibuspan BP (Ibuprofen BP 200mg) Tablets BPR No. COS/BPR /026

ABBREVIATION FULL FORM ABBREVIATION FULL FORM

03. Mfg. Date Manufacturing Date 23 RH Relative Humidity

04. Exp. Date Expiry Date 24 Max Maximum

05. SS Stainless steel 25 Min. Minimum

06. QA Quality Assurance 26 Wt. Weight

07. Reg. No. Registration Number 27 NMT Not more than

08. RM. Stores Raw material stores 28 min Minute(s)

09. QMS Quality Management 29 hrs Hours

11. L Litres 31 Spec. Specification

12. ml Millilitres 32 NLT Not Less Than

13. BOPP Biaxially oriented 33 g Grams

15. N/A Not Applicable 35 BCP Blister packing &

17. BP British Pharmacopeia 37 PA Pascals

18. SOP Standard Operating 38 IPQA In-process quality

Prepared By Reviewed By Approved by

Title: Ibuspan BP (Ibuprofen BP 200mg) Tablets BPR No. COS/BPR /026

ABBREVIATION FULL FORM ABBREVIATION FULL FORM

21. Qty Quantity 41 AR. Analytical report

Area Dispensing room Equipment Weighing

Area cleaned by Equipment No.

Checked By Equipment cleaned by

Previous product Batch No.

Checked By (Packing Supervisor)

Sign & Date

Line clearance Given By (IPQA):

Sign & Date

2.2 Dispensing Instructions

No Step Read by Supervisor

Prepared By Reviewed By Approved by

Title: Ibuspan BP (Ibuprofen BP 200mg) Tablets BPR No. COS/BPR /026

General Dispensing Instructions

2.3 FORMULA PAGE

2.4 DISPENSING OF STARTING MATERIAL

2.4.1 LINE CLEARANCE CHECKLIST

Previous Product: ________________ Batch. No._____________________

Prepared By Reviewed By Approved by

Title: Ibuspan BP (Ibuprofen BP 200mg) Tablets BPR No. COS/BPR /026

2.4.1 LINE CLEARANCE CHECKLIST

Previous Product: ________________ Batch. No._____________________

2.4.2 ENVIRONMENTAL MONITORING

Previous Product: ____________________ Batch No: _______________

DATE TIME PARAMETERS AND LIMITS

Prepared By Reviewed By Approved by

Title: Ibuspan BP (Ibuprofen BP 200mg) Tablets BPR No. COS/BPR /026

2.4.3 WEIGHING OF STARTING MATERIALS

Dispensary Operator Name:

Date: ________________ Date: _______________

3. ISSUANCE OF PACKAGING MATERIAL

3.1 ISSUANCE OF PACKAGING MATERIAL FOR JAR PACKING

Title: Ibuspan BP (Ibuprofen BP 200mg) Tablets BPR No. COS/BPR /026

Date: Date: Date:

3.2 ISSUANCE OF PACKAGING MATERIAL FOR BLISTER PACKING

Prepared By Reviewed By Approved by

Title: Ibuspan BP (Ibuprofen BP 200mg) Tablets BPR No. COS/BPR /026

Date: Date: Date:

4. EXCESS MATERIAL ISSUANCE MATERIAL RECORD

Previous Product: Batch. No._____

Previous Product: Batch. No._____

Previous Product: ______ Batch No: _

Date: __ Date: _

_____Date _ Time _

______ Date _ Time _

Previous Product: Batch. No._____

Previous Product: ______ Batch No: _