BATCH MANUFACTURING RECORD

PLOT 32, LYNSON CHEMICAL AVENUE, KM 38, LAGOS-ABEOKUTA EXPRESSWAY, SANGO-OTA, OGUN STATE
Page 1 of 22

PRODUCT INFORMATION
PRODUCT NAME

CO-DABAMAL
LABEL CLAIM
Each tablet contains
ARTEMETHER
LUMEFANTRINE

NAFDAC REG.
NO.

A4-3584

DOSAGE
FORM

TABLET

PACKAGING
SPECIFICATION
2 x 12 blister pack

SHELF LIFE
2 YEARS

COMPANY NAME
DABAK NIGERIA
LTD.

20mg
120mg

BATCH INFORMATION
JOB NO.

BATCH NUMBER

BATCH SIZE

346

9M606001

139.704Kg
(480,000 tablets)

DATE OF
MANUFACTURE

12/2009

DATE OF EXPIRY

11/2011

AUTHORISATION
QUALITY ASSURANCE MANAGER

PRODUCTION MANAGER

SIGN & DATE

SIGN & DATE

BMR based on Master Formula Record No. [MF003] effective from Batch No. [9D003001]

BATCH MANUFACTURING RECORD

Page 2 of 22

JOB
NO.

PRODUCT NAME

BATCH
N0.

BATCH SIZE

MFG.
DATE

EXP. DATE

346

CO-DABAMAL
TABLET

9M6060
01

139.704Kg
(480,000
tablets)

12/200
9

11/2011

COMPOSITI
ON

PRECAUTION
Ensure that area is clean and clearance given
are properly dressed
Ensure that balances are calibrated and clean
equipments are clean

Ite
m
No.

DESCRIPTION

1.
2.
3.

ARTEMETHER
LUMEFANTRINE
MICROCRYSTALLINE CELLULOSE PLAIN
(M.C.C.P)
LACTOSE (PLAIN)
PREGEL STARCH
METHYL PARABEN
PROPYL PARABEN
POTASSIUM SORBATE
POLYSORBATE 80
POLYVINYL PYROLLIDONE K-30 (PVP K-30)
AEROSIL
TALCUM
MAGNESIUM STEARATE
AC.DI- SOL
DEMINERALISED WATER

4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.

QA MANAGER

PRODUCTION
MANAGER

Ensure that only Approved materials are used

Ensure that personnel

Ensure that dispensed materials are properly identified

Ensure that dispensing

CODE

SPEC.
Standard

mg/tablet

ERM0063
ERM0062

BP
BP

9.60Kg 20mg
57.80Kg 120.4mg

ERM0168

BP

31.20Kg

ERM0016
ERM0073
ERM0023
ERM0024
ERM0039
ERM0153
ERM0038
ERM0019
ERM0035
ERM0034
ERM0030
ERM0107

BP
BP
BP
BP
BP
BP
BP
BP
BP
BP
BP
BP

7.20Kg
4.80Kg
0.40Kg
0.040Kg
0.40Kg
0.24Kg
2.40Kg
0.864Kg
4.80Kg
6.480Kg
13.00Kg

Overage

5%
-

Actual

10.08Kg
57.80Kg
31.20Kg

7.20Kg
4.80Kg
0.40Kg
0.040Kg
0.40Kg
0.24Kg
2.40Kg
0.864Kg
4.80Kg
6.480Kg
13.00Kg

BATCH MANUFACTURING RECORD

Page 3 of 22

JOB
NO.

PRODUCT NAME

BATCH
N0.

BATCH SIZE

MFG.
DATE

EXP. DATE

346

CO-DABAMAL
TABLET

9M6060
01

139.704Kg
(480,000
tablets)

12/200
9

11/2011

WEIGHING

PRECAUTION
Ensure that area is clean and clearance given
are properly dressed
Ensure that balances are calibrated and clean
equipments are clean
WEIGHING BALANCE EQUIPMENT NUMBER:
Ite
m
No.

comment

CODE

AR. NO.

QA MANAGER

PRODUCTION
MANAGER

Ensure that only Approved materials are used

Ensure that personnel

Ensure that dispensed materials are properly identified

Ensure that dispensing

DATE
COMMENCED

EXP.
DATE

Weigh into appropriately labelled polythene bags

1.
ERM006
ARTEMETHER
3
2.
ERM006
LUMEFANTRINE
2
3. MICROCRYSTALLINE
ERM016
CELLULOSE PLAIN (M.C.C.P)
8
4.
ERM001
LACTOSE (PLAIN)
6
5.
ERM007
PREGEL STARCH
3
6.
ERM002
METHYL PARABEN
3
7.
ERM002
PROPYL PARABEN
4
8.
ERM003
POTASSIUM SORBATE
9
9.
ERM015
POLYSORBATE 80
3
10 POLYVINYL PYROLLIDONE KERM003

ACTUAL
WEIGHT

10.08Kg
57.80Kg
31.20Kg
7.20Kg
4.80Kg
0.40Kg
0.040Kg
0.40Kg
0.24Kg
2.40Kg

TOTAL
WEIGHT
TAKEN

DATE COMPLETED

WEIGHT CHECK
STORES

PRODUCTIO
N

QA

BATCH MANUFACTURING RECORD

Page 4 of 22

JOB
NO.

PRODUCT NAME

BATCH
N0.

BATCH SIZE

MFG.
DATE

EXP. DATE

346

CO-DABAMAL
TABLET

9M6060
01

139.704Kg
(480,000
tablets)

12/200
9

11/2011

.
11
.
12
.
13
.
15
.
16
.

30 (PVP K-30)
AEROSIL
TALCUM
MAGNESIUM STEARATE
AC.DI- SOL
DEMINERALISED WATER

BLENDING

8
ERM001
9
ERM003
5
ERM003
4
ERM003
0
ERM010
7

PRECAUTION
Ensure that area is clean and clearance given
Ensure that equipment is clean
Ensure that humidity and temperature are within limits

QA MANAGER

PRODUCTION
MANAGER

0.864Kg
4.80Kg
6.480Kg
13.00Kg

Ensure that personnel are properly dressed

Confirm name and weight of materials before processing

EQUIPMENT CHECK
S.N
o.

EQUIPMENT

1.
2.
3.
4.

PLANETARY MIXER
MULTIMILL
FLUIDISED BED DRYER
MECHANICAL SIFTER

EQUIPMENT NUMBER

CAPACITY

CLEANED BY

CHECKED BY

DATE COMMENCED

REMARK

DATE COMPLETED

BATCH MANUFACTURING RECORD

Page 5 of 22

JOB
NO.

PRODUCT NAME

BATCH
N0.

BATCH SIZE

MFG.
DATE

EXP. DATE

346

CO-DABAMAL
TABLET

9M6060
01

139.704Kg
(480,000
tablets)

12/200
9

11/2011

Step
No.

OPERATION

PROCEDURE

PERFORM THE FOLLOWING OPERATION ON THE FIRST SET OF

WEIGHED MATERIALS.
1.
WEIGHT
Verify that the indicated weight on each
CHECK
ingredient tag corresponds to weight as per
BMR.
2.
SIEVING and 1.Sieve through into polythene lined using
CHARGING
mesh #30:
10.08Kg of Artemether
57.80Kg of Lumefantrine
2.Charge into the sifted materials:
400gof Methyl Paraben.
40g of Propyl Paraben
400g of Potassium Sorbate
4.80Kg of Pregel Starch
7.20Kg of Lactose
31.2Kg of Microcrystalline
Cellulose
3.Charge all the materials into the planetary.
4.Mix the powder thoroughly for 20 minutes at
a low speed.
3.
WET
1)Disperse 240.0g of Polysorbate 80 in hot
MASSING
water to obtain a clear solution; 2.4Kg
of PVP K-30 was dissolved in about
2Litres of cold DM water.
2)Boil the mixture in (1) above and add to the
paste.
3)Mix well.
4)Carefully introduce this solution through the
window of the planetary mixer while the
mixer is working at low speed

QA MANAGER

START
DATE

TIME

DATE

FINISH
TIME

PRODUCTION
MANAGER

PROCESS CHECK
OPERATOR
CHECKED BY

BATCH MANUFACTURING RECORD

Page 6 of 22

JOB
NO.

PRODUCT NAME

BATCH
N0.

BATCH SIZE

MFG.
DATE

EXP. DATE

346

CO-DABAMAL
TABLET

9M6060
01

139.704Kg
(480,000
tablets)

12/200
9

11/2011

5)Mix the wet mass at low speed for 10

minutes and at high speed for about 1
minute.
6)Stop the mixer, lift the lid of the mixer to
observe that the mass is properly formed; if
need be, additional DM water may be
needed to properly wet the mass.
7)Additional water
litre(s)
4.

WET MILLING

5.

DRYING

6.

DRY
SCREENING

7.

LOD

Discharge the wet mass from the planetary

mixer into polythene-lined containers.
Mill the wet mass using the multimill.
1.Load the milled wet mass into the fluidised
bed dryer
2.Set the parameters of the FBD:
Inlet temperature:
60OC
Exhaust flap:
50%
Drying time:
10
minutes
Shaking time:
2
minutes
3.Operate the machine as per SOP.
4.After drying, discharge the partially dried
granules into plastic containers lined with
polythene bags.
1)Sieve dry granules using mesh #12 into
plastic containers lined with polythene bags.
2)Mill the coarse granules and screen using
mesh #8 until all the granules are fine.
Call lab to check LOD of the granules.
Limit[NMT 0.8%]

QA MANAGER

PRODUCTION
MANAGER

BATCH MANUFACTURING RECORD

Page 7 of 22

JOB
NO.

PRODUCT NAME

BATCH
N0.

BATCH SIZE

MFG.
DATE

EXP. DATE

346

CO-DABAMAL
TABLET

9M6060
01

139.704Kg
(480,000
tablets)

12/200
9

11/2011

Step
No.

8.

OPERATION
LUBRICATION
and
BLENDING

PROCEDURE

QA MANAGER

START
DATE

TIME

DATE

FINISH
TIME

PRODUCTION
MANAGER

PROCESS CHECK
OPERATOR
CHECKED BY

1.Record the weight of each combined

granules.
2.Charge the granules into the Octagonal
Blender according to the machines SOP
guidelines.
3.Sieve the following materials through mesh
#20 or #30 of the mechanical Sifter:

AC.DI- SOL
13.00Kg

Aerosil
0.864Kg
Talcum Powder
4.80Kg
Magnesium Stearate
6.480Kg
4.Collect into clean polythene bags and
transfer into the planetary mixer containing
the granules.
5.Blend for 10 minutes.
8.

9.

IN-PROCESS
SAMPLING
DISCHARGIN
G

Fill the In-Process Analysis Request form for Sampled by:

determination of the moisture content of the
granules and notify the QA for sampling (about
20g of granules).
On receiving QA approval, discharge into plastic
containers lined with fresh polythene bags, tie
appropriately and label accordingly. Weigh each

Attach the completed InProcess Analysis Request form

BATCH MANUFACTURING RECORD

Page 8 of 22

JOB
NO.

PRODUCT NAME

BATCH
N0.

BATCH SIZE

MFG.
DATE

EXP. DATE

346

CO-DABAMAL
TABLET

9M6060
01

139.704Kg
(480,000
tablets)

12/200
9

11/2011

QA MANAGER

PRODUCTION
MANAGER

bag and record the weights.

WEIGHT
CHECK

COMPRESSION

Operator:

No. of containers:

Pharmacist:

Weight of Blend:

PRECAUTION
Ensure that area is clean and clearance given
Ensure that equipment is clean
Ensure that humidity and temperature are within limits

Ensure that personnel are properly dressed

Confirm name and weight of materials before processing

EQUIPMENT CHECK
S.No EQUIPMENT
.

1.

EQUIPMENT NUMBER

CAPACITY

CLEANED BY

CHECKED BY

TABLET COMPRESSION
MACHINE
DATE COMMENCED

Step
No.

REMARK

OPERATION

PROCEDURE

START
DATE

TIME

DATE

FINISH
TIME

DATE COMPLETED

PROCESS CHECK
OPERATOR
CHECKED BY

BATCH MANUFACTURING RECORD

Page 9 of 22

JOB
NO.

PRODUCT NAME

BATCH
N0.

BATCH SIZE

MFG.
DATE

EXP. DATE

346

CO-DABAMAL
TABLET

9M6060
01

139.704Kg
(480,000
tablets)

12/200
9

11/2011

1.

TABLET
SPECIFICATIO
N

COMPRESSION WEIGHT TARGET:

mg
UPPER LIMIT:
mg
LOWER LIMIT:
mg
Disintegration time:
NMT 15 minutes
Friability:
NMT 1.0%

QA MANAGER

PRODUCTION
MANAGER

Die size:
Upper punch:
Lower punch:
Checked by:
Average weight:
Average hardness:
Average thickness:
Disintegration time:
Friability:
Operator:

Step
No.

OPERATION

PROCEDURE

START
DATE

TIME

DATE

FINISH
TIME

PROCESS CHECK
OPERATOR
CHECKED BY

BATCH MANUFACTURING RECORD

Page 10 of 22

JOB
NO.

PRODUCT NAME

BATCH
N0.

BATCH SIZE

MFG.
DATE

EXP. DATE

346

CO-DABAMAL
TABLET

9M6060
01

139.704Kg
(480,000
tablets)

12/200
9

11/2011

2.

COMPRESSIO
N

3.

WEIGHT
CHECK

QA MANAGER

PRODUCTION
MANAGER

1. Set the compression machine with dies and

punches.
2. Get the process line clearance from the QA
department.
3. Load the hoppers with the lubricated
granules and set the compression weight of
the tablet.
4. Do initial rotations manually; destroy the
initial tablets.
5. Start the machine and operate as per SOP.
6. Set the compression parameters average
weight, hardness, thickness, friability and
disintegration time.
7. Check for defects like spotting, sticking,
capping, or chipping.
8. Start compression if all parameters are
within the product specification and
maintain these parameters throughout the
compression period.
9. On completion of compression, de-dust the
tablets and pack in SS/HDPE containers
lined with doubled polythene bags.
10. Label appropriately, weigh and record the
weight.
No. of containers:
Net weight of De-dusted tablets:

Operator:

Pharmacist:

BATCH MANUFACTURING RECORD

Page 11 of 22

JOB
NO.

PRODUCT NAME

BATCH
N0.

BATCH SIZE

MFG.
DATE

EXP. DATE

346

CO-DABAMAL
TABLET

9M6060
01

139.704Kg
(480,000
tablets)

12/200
9

11/2011

BLISTERING

7.

OVERPRINTIN
G

1. Obtain line clearance from QA.

2. Prepare the blister packing machine as per
SOP.
3. Install the change part for the product as
per product blister specification.
4. Set the product batch coding stereo using
the batch details on page 1 of the BMR.
5. Mount the printed aluminium foil for the
product and the PVC on the blister packing
machine.
6. Operate the machine to obtain a few empty
blisters. Check the blisters for proper
cutting, coding legibility and leakage test.
7. Check the batch coding on the blisters.
8. On QA approval, load the tablets into the
hopper of the machine and operate the
machine as per SOP.
9. Check for empty pockets. Determine the
leakage test of the blisters every 30
minutes.
10. Prepare the overprinting machine as per
SOP.
11. Set the product batch coding stereo using
the batch details on page 1 of BMR. Confirm
the information.
12. Mount the stereo on the overprinting
machine.

QA MANAGER

PRODUCTION
MANAGER

BATCH MANUFACTURING RECORD

Page 12 of 22

JOB
NO.

PRODUCT NAME

BATCH
N0.

BATCH SIZE

MFG.
DATE

EXP. DATE

346

CO-DABAMAL
TABLET

9M6060
01

139.704Kg
(480,000
tablets)

12/200
9

11/2011

QA MANAGER

PRODUCTION
MANAGER

13. Operate the machine to obtain a few coded

packs and check the batch coding for
legibility and correctness of information.
14. Obtain line clearance from QA.
15. Affix a QA approved sample of pack to the
BMR.
16. Start coding of packs.
8.
PACKAGING
1. Clear the packaging line of any previous
product.
2. Obtain line clearance from QA and start the
packaging.
3. Check for defects.
4. Rejects detected during packaging should
be processed immediately.
5.
DOCUMENT CONTROL
*Every personnel that handled this document should fill this section*

NAME
1.
2.
3.
4.
5.
6.
7.
8.
9.

OPERATION PERFORMED

DATE

SIGNATURE

BATCH MANUFACTURING RECORD

Page 13 of 22

JOB
NO.

PRODUCT NAME

BATCH
N0.

BATCH SIZE

MFG.
DATE

EXP. DATE

346

CO-DABAMAL
TABLET

9M6060
01

139.704Kg
(480,000
tablets)

12/200
9

11/2011

QA MANAGER

PRODUCTION
MANAGER

10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.

OVERPRINTING

PRECAUTION
Ensure that area is clean and clearance given
to BMR
Ensure that overprinting machine is clean and operational

PACKAGING SPECIMEN

Ensure that the batch coding on packaging materials corresponds

Ensure that personnel are properly dressed
DATE COMMENCED
DATE COMPLETED

BATCH MANUFACTURING RECORD

Page 14 of 22

JOB
NO.

PRODUCT NAME

BATCH
N0.

BATCH SIZE

MFG.
DATE

EXP. DATE

346

CO-DABAMAL
TABLET

9M6060
01

139.704Kg
(480,000
tablets)

12/200
9

11/2011

Paste specimens of over print here of initial overprint

PACKAGING MATERIALS RECORD

QA MANAGER

PRODUCTION
MANAGER

Paste specimens of over print here of final overprint

BATCH MANUFACTURING RECORD

Page 15 of 22

JOB
NO.

PRODUCT NAME

BATCH
N0.

BATCH SIZE

MFG.
DATE

EXP. DATE

346

CO-DABAMAL
TABLET

9M6060
01

139.704Kg
(480,000
tablets)

12/200
9

11/2011

ITEM

1
.
2
.
3
.
4
.
5
.
6
.
7
.

Outer Cartons (Shippers)

Co-Dabamal Tablets inner
carton
Co-Dabamal Tablets PVC
Foil
Co-Dabamal Tablets Alufoil
Shrink wraps
BOPP Tape
Leaflets

CODE

AR. No.

REQUIRED

FIRST
ISSUE

200
20,000
240.0K
g
40.00K
g
2,000
16
20,000

*Request for additional pages from QA for more supplementary issue

STORES
(sign)

QA MANAGER

PRODUCTI
ON
(sign)

PRODUCTION
MANAGER

SUPPLEMENTA
RY ISSUE*

STORES
(sign)

PRODUCTI
ON
(sign)

BATCH MANUFACTURING RECORD

Page 16 of 22

JOB
NO.

PRODUCT NAME

BATCH
N0.

BATCH SIZE

MFG.
DATE

EXP. DATE

346

CO-DABAMAL
TABLET

9M6060
01

139.704Kg
(480,000
tablets)

12/200
9

11/2011

QA MANAGER

PRODUCTION
MANAGER

PACKAGING MATERIALS RECONCILIATION

ITEM
1. Outer Cartons (Shippers)
2. Co-Dabamal Tablets inner
carton

3. Co-Dabamal Tablets PVC

Foil
4. Co-Dabamal Tablets
Alufoil
5. Shrink wraps
6. BOPP Tape
7. Leaflets

CODE

TOTAL
ISSUED

TOTAL USED

TOTAL
REJECTS

REASON FOR
REJECT

PRODUCTI
ON
(sign)

SURPLUS
RETURNED

STORES
(sign)

BATCH MANUFACTURING RECORD

Page 17 of 22

JOB
NO.

PRODUCT NAME

BATCH
N0.

BATCH SIZE

MFG.
DATE

EXP. DATE

346

CO-DABAMAL
TABLET

9M6060
01

139.704Kg
(480,000
tablets)

12/200
9

11/2011

QA MANAGER

PRODUCTION
MANAGER

Transfer of rejects to store authorised by:

QA, Signature: . Date:
Comments:

..

BATCH MANUFACTURING RECORD

Page 18 of 22

JOB
NO.

PRODUCT NAME

BATCH
N0.

BATCH SIZE

MFG.
DATE

EXP. DATE

346

CO-DABAMAL
TABLET

9M6060
01

139.704Kg
(480,000
tablets)

12/200
9

11/2011

YIELD

PRODUCTION
MANAGER

To be completed by production Pharmacist

THEORETICAL OUTPUT

1
.
2
.
3
.
4
.
5
.
6
.
7
.

QA MANAGER

GRANULATION AND BLENDING

ACTUAL OUTPUT

% YIELD

139.704Kg

COMPRESSION
BLISTERING
PACKAGING

20,000 inner cartons

QUANTITY SENT TO QUALITY CONTROL DEPARTMENT (Assay and reference sample): .

QUANTITY SENT TO STORE:
DATE

QUANTITY

PACK PRODUCT REPORT NO.

BATCH MANUFACTURING RECORD

Page 19 of 22

JOB
NO.

PRODUCT NAME

BATCH
N0.

BATCH SIZE

MFG.
DATE

EXP. DATE

346

CO-DABAMAL
TABLET

9M6060
01

139.704Kg
(480,000
tablets)

12/200
9

11/2011

QA MANAGER

PRODUCTION
MANAGER

TOTAL QUANTITY
Remarks

..

.
PRODUCTION MANAGER
MANAGER

REMARKS

DESCRIPTION
1.
2.
3.
4.
5.

QUALITY ASSURANCE MANAGER

FACTORY

*All additional information regarding the production process should be documented on this page*

STAGE OF PROCESS

BATCH MANUFACTURING RECORD

Page 20 of 22

JOB
NO.

PRODUCT NAME

BATCH
N0.

BATCH SIZE

MFG.
DATE

EXP. DATE

346

CO-DABAMAL
TABLET

9M6060
01

139.704Kg
(480,000
tablets)

12/200
9

11/2011

QA MANAGER

PRODUCTION
MANAGER

6.
7.
8.
9.
10.

OPERATION
LOG
PROCESS
WEIGHING
GRANULATION and BLENDING
COMPRESSION
PACKAGING

EQUIPMENT(S)

LABOUR

TIME DURATION

BATCH MANUFACTURING RECORD

Page 21 of 22

JOB
NO.

PRODUCT NAME

BATCH
N0.

BATCH SIZE

MFG.
DATE

EXP. DATE

346

CO-DABAMAL
TABLET

9M6060
01

139.704Kg
(480,000
tablets)

12/200
9

11/2011

DOCUMENT CONTROL

NAME
1.
2.
3.
4.
5.
6.
7.

QA MANAGER

PRODUCTION
MANAGER

*Every personnel that handled this document should fill this section*

OPERATION PERFORMED

DATE

SIGNATURE

BATCH MANUFACTURING RECORD

Page 22 of 22

JOB
NO.

PRODUCT NAME

BATCH
N0.

BATCH SIZE

MFG.
DATE

EXP. DATE

346

CO-DABAMAL
TABLET

9M6060
01

139.704Kg
(480,000
tablets)

12/200
9

11/2011

8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.

QA MANAGER

PRODUCTION
MANAGER