Actpro Al Drysyrup 3b001

BATCH MANUFACTURING RECORD
PLOT 32, LYNSON CHEMICAL AVENUE, KM 38, LAGOS-ABEOKUTA EXPRESSWAY, SANGO-OTA, OGUN STATE
Page 1 of 48
PRODUCT INFORMATION
PRODUCT NAME
ACTPRO AL
DRY SYRUP
NAFDAC REG. NO.

A4-2664
DOSAGE FORM
DRY SYRUP
PACKAGING SPECIFICATION
60mL
SHELF LIFE
2 YEARS
LABEL CLAIM
Each 60mL contains
ARTEMETHER
180mg
LUMEFANTRINE 1080mg
BATCH INFORMATION
JOB NO.
004
BATCH NO.
3B004001
BATCH SIZE
0.458kg
(50 BOTTLES)
DATE OF
MANUFACTURE
02/2013
DATE OF EXPIRY
01/2015
AUTHORISATION
QUALITY ASSURANCE MANAGER
PRODUCTION MANAGER
SIGN & DATE
SIGN & DATE

Page 2 0f 15
JOB
NO.
PRODUCT NAME
BATCH
N0.
BATCH SIZE
SHELF
LIFE
MFG.
DATE
EXP. DATE
004
ACTPRO AL DRY
STRUP
3B004001
0.458kg
50 Bottles
2 YEARS
02/2013
01/2015
JO
B
N
O.
PRODUCT NAME
QA MANAGER
BATCH
N0.
PRODUCTION
MANAGER
BATCH
SIZE
MFG.
DATE
EXP.
DATE
QA
MANAG
ER
COMPOSITI
ON
SIGN & DATE
PR
IO
MA

Page 3 0f 15
JOB
NO.
PRODUCT NAME
BATCH
N0.
BATCH SIZE
SHELF
LIFE
MFG.
DATE
EXP. DATE
004
ACTPRO AL DRY
STRUP
3B004001
0.458kg
50 Bottles
2 YEARS
02/2013
01/2015
JO
B
N
O.
PRODUCT NAME
QA MANAGER
BATCH
N0.
Item
No.
DESCRIPTION
CODE
1.
Artemether
ERM0063
BP
2.
LUMEFANTRINE
ERM0062
3.
CITRIC ACID
ERM0103
PRODUCTION
MANAGER
BATCH
SIZE
MFG.
DATE
EXP.
DATE
QA
MANAG
ER
SPEC.
Standard
mg/60mL
Overage
Actual
9.0gm
10%
9.9gm
BP
54.0gm
10%
59.4gm
BP
3.75gm
3.75gm
SIGN & DATE
PR
IO
MA

Page 4 0f 15
JOB
NO.
PRODUCT NAME
BATCH
N0.
BATCH SIZE
SHELF
LIFE
MFG.
DATE
EXP. DATE
004
ACTPRO AL DRY
STRUP
3B004001
0.458kg
50 Bottles
2 YEARS
02/2013
01/2015
JO
B
N
O.
PRODUCT NAME
QA MANAGER
BATCH
N0.
PRODUCTION
MANAGER
BATCH
SIZE
MFG.
DATE
EXP.
DATE
4.
SODIUM CITRATE
ERM0001
BP
5.0gm
5.0gm
5.
ASPARTAME
ERM0010
BP
3.75gm
3.75gm
6.
AVICEL RC 581
ERM0194
BP
16.3gm
16.3gm
7.
XANTHAN GUM
ERM0097
BP
2.5gm
2.5gm
8.
AVICEL PH 112
ERM0032
BP
325.0g
m
QA
MANAG
ER
325.0gm
SIGN & DATE
PR
IO
MA

Page 5 0f 15
JOB
NO.
PRODUCT NAME
BATCH
N0.
BATCH SIZE
SHELF
LIFE
MFG.
DATE
EXP. DATE
004
ACTPRO AL DRY
STRUP
3B004001
0.458kg
50 Bottles
2 YEARS
02/2013
01/2015
JO
B
N
O.
PRODUCT NAME
QA MANAGER
BATCH
N0.
PRODUCTION
MANAGER
BATCH
SIZE
MFG.
DATE
EXP.
DATE
9.
TARTRAZINE YELLOW
ERM0031
BP
35.0mg
35.0mg
10.
STRAWBERRY FLAVOUR
ERM0054
BP
12.5gm
12.5gm
11.
AEROSIL
ERM0019
BP
20.0gm
QA
MANAG
ER
20.0gm
SIGN & DATE
PR
IO
MA

Page 6 0f 15
JOB
NO.
PRODUCT NAME
BATCH
N0.
BATCH SIZE
SHELF
LIFE
MFG.
DATE
EXP. DATE
004
ACTPRO AL DRY
STRUP
3B004001
0.458kg
50 Bottles
2 YEARS
02/2013
01/2015
JO
B
N
O.
PRODUCT NAME
QA MANAGER
BATCH
N0.
PRODUCTION
MANAGER
BATCH
SIZE
MFG.
DATE
EXP.
DATE
QA
MANAG
ER
SIGN & DATE
PR
IO
MA

Page 7 0f 15
JOB
NO.
PRODUCT NAME
BATCH
N0.
BATCH SIZE
SHELF
LIFE
MFG.
DATE
EXP. DATE
004
ACTPRO AL DRY
STRUP
3B004001
0.458kg
50 Bottles
2 YEARS
02/2013
01/2015
JO
B
N
O.
PRODUCT NAME
QA MANAGER
BATCH
N0.
WEIGHING
PRECAUTION
Ensure that area is clean and clearance given
are properly dressed
Ensure that balances are calibrated and clean
equipments are clean
Weigh into appropraitely labelled polythene bags:
PRODUCTION
MANAGER
BATCH
SIZE
MFG.
DATE
EXP.
DATE
QA
MANAG
ER
Ensure that only Approved materials are used
Ensure that personnel
Ensure that dispensed materials are properly identified
Ensure that dispensing
DATE COMMENCED
DATE COMPLETED
WEIGHING BALANCE EQUIPMENT NUMBER:

Ite
m
No.
DESCRIPTION
AR. NO.
EXP. DATE
ACTUAL
WEIGHT
TOTAL
WEIGHT
STORES
WEIGHT CHECK
PROD.
PROD.
QA
SIGN & DATE
PR
IO
MA

Page 8 0f 15
JOB
NO.
PRODUCT NAME
BATCH
N0.
BATCH SIZE
SHELF
LIFE
MFG.
DATE
EXP. DATE
004
ACTPRO AL DRY
STRUP
3B004001
0.458kg
50 Bottles
2 YEARS
02/2013
01/2015
JO
B
N
O.
PRODUCT NAME
QA MANAGER
BATCH
N0.
TAKEN
1.
ARTEMETHER
9.9gm
2.
LUMEFANTRINE
59.4gm
3.
CITRIC ACID
3.75gm
4.
SODIUM CITRATE
5.0gm
PRODUCTION
MANAGER
BATCH
SIZE
MFG.
DATE
EXP.
DATE
QA
MANAG
ER
PHARM
SIGN & DATE
PR
IO
MA

Page 9 0f 15
JOB
NO.
PRODUCT NAME
BATCH
N0.
BATCH SIZE
SHELF
LIFE
MFG.
DATE
EXP. DATE
004
ACTPRO AL DRY
STRUP
3B004001
0.458kg
50 Bottles
2 YEARS
02/2013
01/2015
JO
B
N
O.
PRODUCT NAME
5.
ASPARTAME
3.75gm
6.
AVICEL RC 581
16.3gm
7.
XANTHAN GUM
2.5gm
8.
AVICEL PH 112
325.0gm
9.
TARTRAZINE
35.0mg
QA MANAGER
BATCH
N0.
PRODUCTION
MANAGER
BATCH
SIZE
MFG.
DATE
EXP.
DATE
QA
MANAG
ER
SIGN & DATE
PR
IO
MA

Page 10 0f 15
JOB
NO.
PRODUCT NAME
BATCH
N0.
BATCH SIZE
SHELF
LIFE
MFG.
DATE
EXP. DATE
004
ACTPRO AL DRY
STRUP
3B004001
0.458kg
50 Bottles
2 YEARS
02/2013
01/2015
JO
B
N
O.
PRODUCT NAME
QA MANAGER
BATCH
N0.
PRODUCTION
MANAGER
BATCH
SIZE
MFG.
DATE
EXP.
DATE
QA
MANAG
ER
YELLOW
10
.
STRAWBERRY
FLAVOUR
12.5gm
11
.
AEROSIL
20.0gm
SIGN & DATE
PR
IO
MA

Page 11 0f 15
JOB
NO.
PRODUCT NAME
BATCH
N0.
BATCH SIZE
SHELF
LIFE
MFG.
DATE
EXP. DATE
004
ACTPRO AL DRY
STRUP
3B004001
0.458kg
50 Bottles
2 YEARS
02/2013
01/2015
JO
B
N
O.
PRODUCT NAME
BLENDING
PRECAUTION
Ensure that equipment is clean
Ensure that humidity and temperature are within limits
QA MANAGER
BATCH
N0.
PRODUCTION
MANAGER
BATCH
SIZE
MFG.
DATE
EXP.
DATE
QA
MANAG
ER
Ensure that personnel are properly dressed

Confirm name and weight of materials before processing
EQUIPMENT CHECK
SIGN & DATE
PR
IO
MA

Page 12 0f 15
JOB
NO.
PRODUCT NAME
BATCH
N0.
BATCH SIZE
SHELF
LIFE
MFG.
DATE
EXP. DATE
004
ACTPRO AL DRY
STRUP
3B004001
0.458kg
50 Bottles
2 YEARS
02/2013
01/2015
JO
B
N
O.
PRODUCT NAME
S.No.
1.
2.
3.
4.
EQUIPMENT
QA MANAGER
BATCH
N0.
EQUIPMENT NUMBER
CAPACITY
CLEANED BY
PRODUCTION
MANAGER
BATCH
SIZE
MFG.
DATE
CHECKED BY
EXP.
DATE
QA
MANAG
ER
REMARK
SS DRUM BLENDER
SS SIFTER
SS BUCKETS
SCOOPS, SPATULA
SIGN & DATE
PR
IO
MA

Page 13 0f 15
JOB
NO.
PRODUCT NAME
BATCH
N0.
BATCH SIZE
SHELF
LIFE
MFG.
DATE
EXP. DATE
004
ACTPRO AL DRY
STRUP
3B004001
0.458kg
50 Bottles
2 YEARS
02/2013
01/2015
JO
B
N
O.
QA MANAGER
PRODUCT NAME
BATCH
N0.
PRODUCTION
MANAGER
BATCH
SIZE
DATE COMMENCED
Step
No.
OPERATION
1.
WEIGHT
CHECK
DRYING
PROCEDURE
START
DATE
TIME
DATE
FINISH
TIME
MFG.
DATE
EXP.
DATE
QA
MANAG
ER
DATE COMPLETED
PROCESS CHECK
OPERATOR
CHECKED BY
Verify that the indicated weight on each

ingredient tag corresponds to weight as per
BMR.
Dry the following materials in the Tray
SIGN & DATE
PR
IO
MA

Page 14 0f 15
JOB
NO.
PRODUCT NAME
BATCH
N0.
BATCH SIZE
SHELF
LIFE
MFG.
DATE
EXP. DATE
004
ACTPRO AL DRY
STRUP
3B004001
0.458kg
50 Bottles
2 YEARS
02/2013
01/2015
JO
B
N
O.
3.
PRODUCT NAME
SIEVING
QA MANAGER
BATCH
N0.
PRODUCTION
MANAGER
BATCH
SIZE
MFG.
DATE
EXP.
DATE
QA
MANAG
ER
drier at about 80C -90C for 4 5 hrs.

2.5gm of Xanthan gum, 16.3gm of Avicel
RC 581,3.75gm of Citric acid, 325.0gm of
Avicel pH 112, 5.0gm of Sodium citrate
Charge 9.9gm of Artemether, 59.4gm of
Lumefantrine, Citric acid, Sodium Citrate,
Aspartame, Avicel RC 591, Xanthan gum,
Avicel PH 112, Tartrazine Yellow, Aerosil
SIGN & DATE
PR
IO
MA

Page 15 0f 15
JOB
NO.
PRODUCT NAME
BATCH
N0.
BATCH SIZE
SHELF
LIFE
MFG.
DATE
EXP. DATE
004
ACTPRO AL DRY
STRUP
3B004001
0.458kg
50 Bottles
2 YEARS
02/2013
01/2015
JO
B
N
O.
PRODUCT NAME
4.
Discharging
5.
IN-PROCESS
SAMPLING
QA MANAGER
BATCH
N0.
and Strawberry Flavour into the Drum

Blender and blend for 10 minutes.
Discharge the powder mixture into an SS drum
lined with two polyethylene bags. Tie properly
and label appropriately.
Fill the In-Process Analysis Request form and
forward to QA for sampling and analysis.
Sampled by:
PRODUCTION
MANAGER
BATCH
SIZE
MFG.
DATE
EXP.
DATE
QA
MANAG
ER
Attach the completed InProcess Analysis Request

form
SIGN & DATE
PR
IO
MA

Page 16 0f 15
JOB
NO.
PRODUCT NAME
BATCH
N0.
BATCH SIZE
SHELF
LIFE
MFG.
DATE
EXP. DATE
004
ACTPRO AL DRY
STRUP
3B004001
0.458kg
50 Bottles
2 YEARS
02/2013
01/2015
JO
B
N
O.
PRODUCT NAME
7.
DISCHARGIN
G
On QA approval, discharge the powder blend

into SS drums lined with double polyethylene
bags. Tie properly and label appropriately.
Determine and record weight of the blend.
8.
WEIGHT
CHECK
No. of containers:
QA MANAGER
BATCH
N0.
Weight of Blend:
Operator:
PRODUCTION
MANAGER
BATCH
SIZE
MFG.
DATE
EXP.
DATE
QA
MANAG
ER
Pharmacist:
SIGN & DATE
PR
IO
MA

Page 17 0f 15
JOB
NO.
PRODUCT NAME
BATCH
N0.
BATCH SIZE
SHELF
LIFE
MFG.
DATE
EXP. DATE
004
ACTPRO AL DRY
STRUP
3B004001
0.458kg
50 Bottles
2 YEARS
02/2013
01/2015
JO
B
N
O.
PRODUCT NAME
QA MANAGER
BATCH
N0.
PRODUCTION
MANAGER
BATCH
SIZE
MFG.
DATE
EXP.
DATE
QA
MANAG
ER
SIGN & DATE
PR
IO
MA

Page 18 0f 15
JOB
NO.
PRODUCT NAME
BATCH
N0.
BATCH SIZE
SHELF
LIFE
MFG.
DATE
EXP. DATE
004
ACTPRO AL DRY
STRUP
3B004001
0.458kg
50 Bottles
2 YEARS
02/2013
01/2015
JO
B
N
O.
PRODUCT NAME
QA MANAGER
BATCH
N0.
PRODUCTION
MANAGER
BATCH
SIZE
MFG.
DATE
EXP.
DATE
QA
MANAG
ER
SIGN & DATE
PR
IO
MA

Page 19 0f 15
JOB
NO.
PRODUCT NAME
BATCH
N0.
BATCH SIZE
SHELF
LIFE
MFG.
DATE
EXP. DATE
004
ACTPRO AL DRY
STRUP
3B004001
0.458kg
50 Bottles
2 YEARS
02/2013
01/2015
JO
B
N
O.
PRODUCT NAME
FILLING
CAPPING
PRECAUTION
Ensure that equipment is clean
QA MANAGER
BATCH
N0.
PRODUCTION
MANAGER
BATCH
SIZE
MFG.
DATE
EXP.
DATE
QA
MANAG
ER

Confirm name and weight of materials before processing
SIGN & DATE
PR
IO
MA

Page 20 0f 15
JOB
NO.
PRODUCT NAME
BATCH
N0.
BATCH SIZE
SHELF
LIFE
MFG.
DATE
EXP. DATE
004
ACTPRO AL DRY
STRUP
3B004001
0.458kg
50 Bottles
2 YEARS
02/2013
01/2015
JO
B
N
O.
QA MANAGER
PRODUCT NAME
BATCH
N0.
PRODUCTION
MANAGER
BATCH
SIZE
MFG.
DATE
EXP.
DATE
QA
MANAG
ER
Ensure that humidity and temperature are within limits
EQUIPMENT CHECK
S.No
.
1.
EQUIPMENT
EQUIPMENT NUMBER
CAPACITY
CLEANED BY
CHECKED BY
REMARK
SINGLE-HEAD FILLING
MACHINE
SIGN & DATE
PR
IO
MA

Page 21 0f 15
JOB
NO.
PRODUCT NAME
BATCH
N0.
BATCH SIZE
SHELF
LIFE
MFG.
DATE
EXP. DATE
004
ACTPRO AL DRY
STRUP
3B004001
0.458kg
50 Bottles
2 YEARS
02/2013
01/2015
JO
B
N
O.
2.
3.
QA MANAGER
PRODUCT NAME
BATCH
N0.
PRODUCTION
MANAGER
BATCH
SIZE
1.
EXP.
DATE
QA
MANAG
ER
CAPPING MACHINE
LABELLING MACHINE
DATE COMMENCED
Step
No.
MFG.
DATE
OPERATION
FILL WEIGHT
PROCEDURE
START
DATE
TIME
DATE
FINISH
TIME
DATE COMPLETED
PROCESS CHECK
OPERATOR
CHECKED BY
FILL WEIGHT
TARGET:
SIGN & DATE
PR
IO
MA

Page 22 0f 15
JOB
NO.
PRODUCT NAME
BATCH
N0.
BATCH SIZE
SHELF
LIFE
MFG.
DATE
EXP. DATE
004
ACTPRO AL DRY
STRUP
3B004001
0.458kg
50 Bottles
2 YEARS
02/2013
01/2015
JO
B
N
O.
PRODUCT NAME
QA MANAGER
BATCH
N0.
PRODUCTION
MANAGER
BATCH
SIZE
MFG.
DATE
EXP.
DATE
QA
MANAG
ER
9.16g
2.
FILLING &
CAPPING
UPPER LIMIT:
9.39g
LOWER LIMIT:
8.93g
1. Obtain line clearance from QA.
2. Load the approved powder blend into the
hopper.
3. Operate the machine as per SOP to set the
SIGN & DATE
PR
IO
MA

Page 23 0f 15
JOB
NO.
PRODUCT NAME
BATCH
N0.
BATCH SIZE
SHELF
LIFE
MFG.
DATE
EXP. DATE
004
ACTPRO AL DRY
STRUP
3B004001
0.458kg
50 Bottles
2 YEARS
02/2013
01/2015
JO
B
N
O.
PRODUCT NAME
QA MANAGER
BATCH
N0.
PRODUCTION
MANAGER
BATCH
SIZE
MFG.
DATE
EXP.
DATE
QA
MANAG
ER
fill weight.
4. Set the threading of the capping machine
5. Once weight and capping is approved,
commence with the filling.
6. Start capping of the bottles immediately.
7. Check the weight of the bottles every
15minutes.
8. Continue filling and capping until powder is
SIGN & DATE
PR
IO
MA

Page 24 0f 15
JOB
NO.
PRODUCT NAME
BATCH
N0.
BATCH SIZE
SHELF
LIFE
MFG.
DATE
EXP. DATE
004
ACTPRO AL DRY
STRUP
3B004001
0.458kg
50 Bottles
2 YEARS
02/2013
01/2015
JO
B
N
O.
PRODUCT NAME
3.
DUSTING
4.
LABELLING
QA MANAGER
BATCH
N0.
PRODUCTION
MANAGER
BATCH
SIZE
MFG.
DATE
EXP.
DATE
QA
MANAG
ER
exhausted or until fill weight remains out of

limit.
Collect the bottles into suitable containers.
Clean each bottle with a moist cloth to remove
powder from bottle.
Set the product batch coding stereo on the

labelling machine using the batch details
on page 1 of BMR. Confirm the information.
SIGN & DATE
PR
IO
MA

Page 25 0f 15
JOB
NO.
PRODUCT NAME
BATCH
N0.
BATCH SIZE
SHELF
LIFE
MFG.
DATE
EXP. DATE
004
ACTPRO AL DRY
STRUP
3B004001
0.458kg
50 Bottles
2 YEARS
02/2013
01/2015
JO
B
N
O.
PRODUCT NAME
QA MANAGER
BATCH
N0.
PRODUCTION
MANAGER
BATCH
SIZE
MFG.
DATE
EXP.
DATE
QA
MANAG
ER
Mount some labels on the machine and

label some few bottles for QC approval of
the batch coding and neatness of labelling.
Obtain line clearance.
On QC approval, start the labelling of the
bottles.
Check regularly to ensure that the batch
SIGN & DATE
PR
IO
MA

Page 26 0f 15
JOB
NO.
PRODUCT NAME
BATCH
N0.
BATCH SIZE
SHELF
LIFE
MFG.
DATE
EXP. DATE
004
ACTPRO AL DRY
STRUP
3B004001
0.458kg
50 Bottles
2 YEARS
02/2013
01/2015
JO
B
N
O.
5.
PRODUCT NAME
OVERPRINTIN
G
QA MANAGER
BATCH
N0.
PRODUCTION
MANAGER
BATCH
SIZE
MFG.
DATE
EXP.
DATE
QA
MANAG
ER
coding is clearly printed.

Affix a QA approved sample of label to the
BMR.
Prepare the overprinting machine as per
SOP.
Set the product batch coding stereo using
the batch details on page 1 of BMR.
SIGN & DATE
PR
IO
MA

Page 27 0f 15
JOB
NO.
PRODUCT NAME
BATCH
N0.
BATCH SIZE
SHELF
LIFE
MFG.
DATE
EXP. DATE
004
ACTPRO AL DRY
STRUP
3B004001
0.458kg
50 Bottles
2 YEARS
02/2013
01/2015
JO
B
N
O.
PRODUCT NAME
QA MANAGER
BATCH
N0.
PRODUCTION
MANAGER
BATCH
SIZE
MFG.
DATE
EXP.
DATE
QA
MANAG
ER
Confirm the information.

Mount the stereo on the overprinting
machine.
Operate the machine to obtain a few coded
packs and check the batch coding for
legibility and correctness of information.
Obtain line clearance from QA.
SIGN & DATE
PR
IO
MA

Page 28 0f 15
JOB
NO.
PRODUCT NAME
BATCH
N0.
BATCH SIZE
SHELF
LIFE
MFG.
DATE
EXP. DATE
004
ACTPRO AL DRY
STRUP
3B004001
0.458kg
50 Bottles
2 YEARS
02/2013
01/2015
JO
B
N
O.
6.
PRODUCT NAME
PACKAGING
QA MANAGER
BATCH
N0.
PRODUCTION
MANAGER
BATCH
SIZE
MFG.
DATE
EXP.
DATE
QA
MANAG
ER
Affix a QA approved sample of pack to the

BMR.
Start coding of packs.
1. Clear the packaging line of any previous
product.
2. Obtain line clearance from QA and start
the packaging.
SIGN & DATE
PR
IO
MA

Page 29 0f 15
JOB
NO.
PRODUCT NAME
BATCH
N0.
BATCH SIZE
SHELF
LIFE
MFG.
DATE
EXP. DATE
004
ACTPRO AL DRY
STRUP
3B004001
0.458kg
50 Bottles
2 YEARS
02/2013
01/2015
JO
B
N
O.
PRODUCT NAME
QA MANAGER
BATCH
N0.
PRODUCTION
MANAGER
BATCH
SIZE
MFG.
DATE
EXP.
DATE
QA
MANAG
ER
3. Rejects detected during packaging

should be processed immediately.
SIGN & DATE
PR
IO
MA

Page 30 0f 15
JOB
NO.
PRODUCT NAME
BATCH
N0.
BATCH SIZE
SHELF
LIFE
MFG.
DATE
EXP. DATE
004
ACTPRO AL DRY
STRUP
3B004001
0.458kg
50 Bottles
2 YEARS
02/2013
01/2015
JO
B
N
O.
PRODUCT NAME
REMARKS
QA MANAGER
BATCH
N0.
PRODUCTION
MANAGER
BATCH
SIZE
MFG.
DATE
EXP.
DATE
QA
MANAG
ER
*All additional information regarding the production process should be documented on this page*
SIGN & DATE
PR
IO
MA

Page 31 0f 15
JOB
NO.
PRODUCT NAME
BATCH
N0.
BATCH SIZE
SHELF
LIFE
MFG.
DATE
EXP. DATE
004
ACTPRO AL DRY
STRUP
3B004001
0.458kg
50 Bottles
2 YEARS
02/2013
01/2015
JO
B
N
O.
PRODUCT NAME
DESCRIPTION OF DEVIATION
QA MANAGER
BATCH
N0.
STAGE OF PROCESS DEVIATION OCCURRED
PRODUCTION
MANAGER
BATCH
SIZE
MFG.
DATE
EXP.
DATE
QA
MANAG
ER
JUSTIFICATION
SIGN & DATE
PR
IO
MA

Page 32 0f 15
JOB
NO.
PRODUCT NAME
BATCH
N0.
BATCH SIZE
SHELF
LIFE
MFG.
DATE
EXP. DATE
004
ACTPRO AL DRY
STRUP
3B004001
0.458kg
50 Bottles
2 YEARS
02/2013
01/2015
JO
B
N
O.
PRODUCT NAME
QA MANAGER
BATCH
N0.
PRODUCTION
MANAGER
BATCH
SIZE
MFG.
DATE
EXP.
DATE
QA
MANAG
ER
OPERATION
LOG
PROCESS
EQUIPMENT(S)
LABOUR
TIME DURATION
SIGN & DATE
PR
IO
MA

Page 33 0f 15
JOB
NO.
PRODUCT NAME
BATCH
N0.
BATCH SIZE
SHELF
LIFE
MFG.
DATE
EXP. DATE
004
ACTPRO AL DRY
STRUP
3B004001
0.458kg
50 Bottles
2 YEARS
02/2013
01/2015
JO
B
N
O.
PRODUCT NAME
QA MANAGER
BATCH
N0.
PRODUCTION
MANAGER
BATCH
SIZE
MFG.
DATE
EXP.
DATE
QA
MANAG
ER
WEIGHING
BLENDING
FILLING
SIGN & DATE
PR
IO
MA

Page 34 0f 15
JOB
NO.
PRODUCT NAME
BATCH
N0.
BATCH SIZE
SHELF
LIFE
MFG.
DATE
EXP. DATE
004
ACTPRO AL DRY
STRUP
3B004001
0.458kg
50 Bottles
2 YEARS
02/2013
01/2015
JO
B
N
O.
PRODUCT NAME
QA MANAGER
BATCH
N0.
PRODUCTION
MANAGER
BATCH
SIZE
MFG.
DATE
EXP.
DATE
QA
MANAG
ER
CAPPING
DUSTING
LABELLING
SIGN & DATE
PR
IO
MA

Page 35 0f 15
JOB
NO.
PRODUCT NAME
BATCH
N0.
BATCH SIZE
SHELF
LIFE
MFG.
DATE
EXP. DATE
004
ACTPRO AL DRY
STRUP
3B004001
0.458kg
50 Bottles
2 YEARS
02/2013
01/2015
JO
B
N
O.
PRODUCT NAME
DOCUMENT CONTROL
NAME
QA MANAGER
BATCH
N0.
PRODUCTION
MANAGER
BATCH
SIZE
MFG.
DATE
EXP.
DATE
QA
MANAG
ER
*Every personnel that has to document any information into BMR should fill this section*
OPERATION PERFORMED
DATE
SIGNATURE
1.
SIGN & DATE
PR
IO
MA

Page 36 0f 15
JOB
NO.
PRODUCT NAME
BATCH
N0.
BATCH SIZE
SHELF
LIFE
MFG.
DATE
EXP. DATE
004
ACTPRO AL DRY
STRUP
3B004001
0.458kg
50 Bottles
2 YEARS
02/2013
01/2015
JO
B
N
O.
PRODUCT NAME
QA MANAGER
BATCH
N0.
PRODUCTION
MANAGER
BATCH
SIZE
MFG.
DATE
EXP.
DATE
QA
MANAG
ER
2.
3.
4.
5.
6.
7.
SIGN & DATE
PR
IO
MA

Page 37 0f 15
JOB
NO.
PRODUCT NAME
BATCH
N0.
BATCH SIZE
SHELF
LIFE
MFG.
DATE
EXP. DATE
004
ACTPRO AL DRY
STRUP
3B004001
0.458kg
50 Bottles
2 YEARS
02/2013
01/2015
JO
B
N
O.
PRODUCT NAME
QA MANAGER
BATCH
N0.
PRODUCTION
MANAGER
BATCH
SIZE
MFG.
DATE
EXP.
DATE
QA
MANAG
ER
8.
9.
10.
11.
12.
13.
SIGN & DATE
PR
IO
MA

Page 38 0f 15
JOB
NO.
PRODUCT NAME
BATCH
N0.
BATCH SIZE
SHELF
LIFE
MFG.
DATE
EXP. DATE
004
ACTPRO AL DRY
STRUP
3B004001
0.458kg
50 Bottles
2 YEARS
02/2013
01/2015
JO
B
N
O.
PRODUCT NAME
QA MANAGER
BATCH
N0.
PRODUCTION
MANAGER
BATCH
SIZE
MFG.
DATE
EXP.
DATE
QA
MANAG
ER
14.
15.
SIGN & DATE
PR
IO
MA

Page 39 0f 15
JOB
NO.
PRODUCT NAME
BATCH
N0.
BATCH SIZE
SHELF
LIFE
MFG.
DATE
EXP. DATE
004
ACTPRO AL DRY
STRUP
3B004001
0.458kg
50 Bottles
2 YEARS
02/2013
01/2015
JO
B
N
O.
PRODUCT NAME
OVERPRINTING
QA MANAGER
BATCH
N0.
PRECAUTION
to BMR
Ensure that overprinting machine is clean and operational
PACKAGING SPECIMEN
PRODUCTION
MANAGER
BATCH
SIZE
MFG.
DATE
EXP.
DATE
QA
MANAG
ER
Ensure that the batch coding on packaging materials corresponds

DATE COMMENCED
DATE COMPLETED
SIGN & DATE
PR
IO
MA

Page 40 0f 15
JOB
NO.
PRODUCT NAME
BATCH
N0.
BATCH SIZE
SHELF
LIFE
MFG.
DATE
EXP. DATE
004
ACTPRO AL DRY
STRUP
3B004001
0.458kg
50 Bottles
2 YEARS
02/2013
01/2015
JO
B
N
O.
PRODUCT NAME
Paste specimens of over print here of initial overprint
QA MANAGER
BATCH
N0.
PRODUCTION
MANAGER
BATCH
SIZE
MFG.
DATE
EXP.
DATE
QA
MANAG
ER
Paste specimens of over print here of final overprint
SIGN & DATE
PR
IO
MA

Page 41 0f 15
JOB
NO.
PRODUCT NAME
BATCH
N0.
BATCH SIZE
SHELF
LIFE
MFG.
DATE
EXP. DATE
004
ACTPRO AL DRY
STRUP
3B004001
0.458kg
50 Bottles
2 YEARS
02/2013
01/2015
JO
B
N
O.
QA MANAGER
PRODUCT NAME
PACKAGING MATERIALS RECORD

CODE
ITEM
BATCH
N0.
AR. No.
REQUIRED
FIRST
ISSUE
STORES
(sign)
PRODUCTI
ON
(sign)
PRODUCTION
MANAGER
BATCH
SIZE
SUPPLEMENTA
RY ISSUE*
MFG.
DATE
STORES
(sign)
EXP.
DATE
QA
MANAG
ER
PRODUCTION
(sign)
SIGN & DATE
PR
IO
MA

Page 42 0f 15
JOB
NO.
PRODUCT NAME
BATCH
N0.
BATCH SIZE
SHELF
LIFE
MFG.
DATE
EXP. DATE
004
ACTPRO AL DRY
STRUP
3B004001
0.458kg
50 Bottles
2 YEARS
02/2013
01/2015
JO
B
N
O.
PRODUCT NAME
1.
2.
Actpro Al dry syrup inner

Cartons
60ml Bottles
3.
ROPP Caps; 28mm,
4.
Actpro Al dry syrup Labels
QA MANAGER
BATCH
N0.
PRODUCTION
MANAGER
BATCH
SIZE
MFG.
DATE
EXP.
DATE
QA
MANAG
ER
EPM021
0
EPM021
1
SIGN & DATE
PR
IO
MA

Page 43 0f 15
JOB
NO.
PRODUCT NAME
BATCH
N0.
BATCH SIZE
SHELF
LIFE
MFG.
DATE
EXP. DATE
004
ACTPRO AL DRY
STRUP
3B004001
0.458kg
50 Bottles
2 YEARS
02/2013
01/2015
JO
B
N
O.
PRODUCT NAME
5.
Leaflets
6.
Dosage Cup
QA MANAGER
BATCH
N0.
PRODUCTION
MANAGER
BATCH
SIZE
MFG.
DATE
EXP.
DATE
QA
MANAG
ER
*Request for additional pages from QA for more supplementary issue
SIGN & DATE
PR
IO
MA

Page 44 0f 15
JOB
PRODUCT NAME
NO.
PACKAGING
YIELD
004
ACTPRO AL DRY
STRUP
BATCH
BATCH SIZE SHELF
MFG.
N0.
LIFE Pharmacist
DATE
To be completed by production
3B004001
PRODUCT NAME
1JO BLENDING
B
.
2N PACKAGING
O.
.
3
.
4
.
0.458kg
2 YEARS 02/2013
50
Bottles
THEORETICAL
OUTPUT
EXP. DATE
QA MANAGER
PRODUCTION
MANAGER
01/2015
ACTUAL OUTPUT
% YIELD
BATCH
N0.
BATCH
SIZE
MFG.
DATE
EXP.
DATE
QA
MANAG
ER
2,000 bottles
QUANTITY SENT TO QUALITY CONTROL DEPARTMENT (Assay and reference sample): .

QUANTITY SENT TO STORE:
DATE
PACKAGING MATERIALS RECONCILIATION

CODE
ITEM
QUANTITY
TOTAL ISSUED
TOTAL USED
TOTAL REJECTS
PACK PRODUCT REPORT NO.
REASON FOR
REJECT
PRODUCTIO
N
(sign)
SURPLUS
RETURNE
D
STORES
(sign)
TOTAL QUANTITY
1. Actpro Al dry syrup inner EPM0210
Cartons
Remarks
2. 60ml Bottles
..
OPERATION
3.
ROPP Caps; 28mm,
LOG
4. Actpro Al dry syrup Labels EPM0211

.
PROCESS
EQUIPMENT(S)
LABOUR
TIME DURATION
5. Leaflets
6. PRODUCTION
Dosage Cup MANAGER
MANAGER
QUALITY ASSURANCE MANAGER
FACTORY
SIGN & DATE
PR
IO
MA

Page 45 0f 15
JOB
NO.
PRODUCT NAME
BATCH
N0.
BATCH SIZE
SHELF
LIFE
MFG.
DATE
EXP. DATE
004
ACTPRO AL DRY
STRUP
3B004001
0.458kg
50 Bottles
2 YEARS
02/2013
01/2015
JO
B
N
O.
PRODUCT NAME
QA MANAGER
BATCH
N0.
PRODUCTION
MANAGER
BATCH
SIZE
MFG.
DATE
EXP.
DATE
QA
MANAG
ER
OVERPRINTING
PACKAGING
DOCUMENT CONTROL
*Every personnel that has to document any information into BMR should fill this section*
SIGN & DATE
PR
IO
MA

Page 46 0f 15
JOB
NO.
PRODUCT NAME
BATCH
N0.
BATCH SIZE
SHELF
LIFE
MFG.
DATE
EXP. DATE
004
ACTPRO AL DRY
STRUP
3B004001
0.458kg
50 Bottles
2 YEARS
02/2013
01/2015
JO
B
N
O.
PRODUCT NAME
NAME
QA MANAGER
BATCH
N0.
OPERATION PERFORMED
DATE
PRODUCTION
MANAGER
BATCH
SIZE
MFG.
DATE
EXP.
DATE
QA
MANAG
ER
SIGNATURE
1.
2.
3.
4.
SIGN & DATE
PR
IO
MA

Page 47 0f 15
JOB
NO.
PRODUCT NAME
BATCH
N0.
BATCH SIZE
SHELF
LIFE
MFG.
DATE
EXP. DATE
004
ACTPRO AL DRY
STRUP
3B004001
0.458kg
50 Bottles
2 YEARS
02/2013
01/2015
JO
B
N
O.
PRODUCT NAME
QA MANAGER
BATCH
N0.
PRODUCTION
MANAGER
BATCH
SIZE
MFG.
DATE
EXP.
DATE
QA
MANAG
ER
5.
6.
7.
8.
SIGN & DATE
PR
IO
MA

Page 48 0f 15
JOB
NO.
PRODUCT NAME
BATCH
N0.
BATCH SIZE
SHELF
LIFE
MFG.
DATE
EXP. DATE
004
ACTPRO AL DRY
STRUP
3B004001
0.458kg
50 Bottles
2 YEARS
02/2013
01/2015
JO
B
N
O.
PRODUCT NAME
QA MANAGER
BATCH
N0.
PRODUCTION
MANAGER
BATCH
SIZE
MFG.
DATE
EXP.
DATE
QA
MANAG
ER
SIGN & DATE
PR
IO
MA

Actpro Al Drysyrup 3b001

Încărcat de

Informații document

Drepturi de autor

Formate disponibile

Partajați acest document

Partajați sau inserați document

Opțiuni de partajare

Vi se pare util acest document?

Este necorespunzător acest conținut?

Drepturi de autor:

Formate disponibile

Actpro Al Drysyrup 3b001

Încărcat de

Drepturi de autor:

Formate disponibile

BATCH MANUFACTURING RECORD

NAFDAC REG. NO.

SIGN & DATE

SIGN & DATE

BATCH MANUFACTURING RECORD

SIGN & DATE

BATCH MANUFACTURING RECORD

SIGN & DATE

BATCH MANUFACTURING RECORD

SIGN & DATE

BATCH MANUFACTURING RECORD

SIGN & DATE

BATCH MANUFACTURING RECORD

SIGN & DATE

BATCH MANUFACTURING RECORD

Ensure that only Approved materials are used

Ensure that personnel

Ensure that dispensed materials are properly identified

Ensure that dispensing

WEIGHING BALANCE EQUIPMENT NUMBER:

BATCH MANUFACTURING RECORD

SIGN & DATE

BATCH MANUFACTURING RECORD

SIGN & DATE

BATCH MANUFACTURING RECORD

SIGN & DATE

BATCH MANUFACTURING RECORD

Ensure that personnel are properly dressed

BATCH MANUFACTURING RECORD

SIGN & DATE

BATCH MANUFACTURING RECORD

Verify that the indicated weight on each

SIGN & DATE

BATCH MANUFACTURING RECORD

drier at about 80C -90C for 4 5 hrs.

SIGN & DATE

BATCH MANUFACTURING RECORD

and Strawberry Flavour into the Drum

Attach the completed InProcess Analysis Request

SIGN & DATE

BATCH MANUFACTURING RECORD

On QA approval, discharge the powder blend

SIGN & DATE

BATCH MANUFACTURING RECORD

SIGN & DATE

BATCH MANUFACTURING RECORD

SIGN & DATE

BATCH MANUFACTURING RECORD

Ensure that personnel are properly dressed

SIGN & DATE

BATCH MANUFACTURING RECORD

Ensure that humidity and temperature are within limits

BATCH MANUFACTURING RECORD

BATCH MANUFACTURING RECORD

SIGN & DATE

BATCH MANUFACTURING RECORD

SIGN & DATE

BATCH MANUFACTURING RECORD

exhausted or until fill weight remains out of

Set the product batch coding stereo on the

BATCH MANUFACTURING RECORD

Mount some labels on the machine and

SIGN & DATE

BATCH MANUFACTURING RECORD