UNICURE PHARMACEUTICAL LIMITED
Batch manufacturing Record
Product: Page 1 of 27
Date:
B.M.R. No:

Batch Quantity:

Reworking Added:
AMLODIPINE
1.5 million tablets.
Batch size:
Specification:
Batch no:
1.5 MILLION
5mg
COMPOSITION
Each film coated tablet contains:
AMLODIPINE BESILATE BP
Color : WHITE



Theoretical yield :
Mfg. date:
This Document supersedes : None

Reason for Change : New

NAFDAC No.:


Shelf Life
Storage Condition


Exp. Date:
Material code No.:
:36 Months
: store in cool, dry place, away from light.
Granulation
Compression
Date of commencement:
Date of completion:
Coating










Area used :
Previous product processed
Actual yield: ________
Tablets Reworking Generated: _________kg.
Total yield : ________%
Packing
Start date :____________ end date:________
No of cartons: _________
Final BMR Checked by QA:
Final BMR Checked by :
Date :
Date :
Checked By
Reviewed By
 Prepared By
Production
Production head
 Quality Assurance

Date :
Date:
Date:
 Date:
Approved By
QA %QC Head
UNICURE PHARMACEUTICAL LIMITED
Batch manufacturing Record
Product: Page 2 of 27
Date:
B.M.R. No:
AMLODIPINE
Batch size:
Specification:
Batch no:
1.5 MILLION
5mg
Precaution for safety :



Safety precaution to be taken against explosive in fluidized bed drier & while grinding.
Protect the respiratory organs from active substance.
Store the granules & tablets in well closed containers lined with double polythene bags.
Notes:
1.
2.
3.
4.
5.
6.
Manufacturing is to be carried out as per requirement of current GMP.
Use clean and dry S.S. equipment at all stages of ,manufacturing.
Carry out sifting and milling operation near dust extraction.
All equipment and machinery must be adequately guarded and earthed.
The operators must use proper safety equipment like gloves, nose mask,ear muffs etc. during all operation.
Ensure that general cleaning &utensils are carried out as per respective S.S., FBD, screens, compression machine
coating pan &tools and accessories etc. are cleaned as per respective S.C.P. & checked for cleanliness before use.
7. Ensure that RMG, V-Blender, mutimill, Vibratory sifter,S.S. Sieves,S.S., FBDS, Screens, Compression machine coating
pan & tools and accessories etc. are cleaned as per respective S.C.P.
8. Before weighing operations, calibrate, center and check cleanliness of balance as per S.C.P.
9. Batch size may vary depending upon the equipment .prior permission of QA/QC should be obtained except in the
case of batch in which reworking is added.
10. Destroy all rejected material & tablets by QC dept, prior to use and must be within retest date.
General instruction for manufacturing
Cleaning record of machinery & Equipment
Sr.
No.
Machinery/ equipment
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
Weighing ;floor scale
Analytical balance
Heating tank
RMG
Sieves/sieve shaker
Mutimill
Fluidized bed dryer
v- Blender
Vessels, Scoops & Spatulas
Compression machine
11.
12.
Coating pan
Tools buckets and other
assessories
capacity
350kg
220g
500l
250lts
500l
2000ltrs.
31/35
station
42’
-
Equipment Previous
No(s)
Product &B.
no.
cleaned
on
By
Chd.
By
Re-chd.
By
UNICURE PHARMACEUTICAL LIMITED
Batch manufacturing Record
Product: Page 3 of 27
Date:
B.M.R. No:
AMLODIPINE
Batch size:
Specification:
Batch no:
WAREHOUSE/ BUFFER ROOM –Line Cleanrance Record
Previous product processed:
Batch No:
completed on:
Sr. no
Description
time:
Remark
Yes/no
1.5 MILLION
5mg
Checked by
(prod.)
Rechecked by
(Q.A)
1.
2.
3.
4.
5.
6.
7.
Label (s) of previous product
Tablets/Granules of previous product
Container(s) of previous product
Area cleanliness(floor, walls)
Grinding Machine is ready and clean properly
Area is approved for operation by Q.A.
o
Temp. =
c, Humidity =
% RH
Line Clearance is Satisfactory / not satisfactory.
Line Cleared By (prod.)
Date:
Time:
Checked by(QA):
Date:
Time:
Bill of Raw Material & Weighing Record
s/
No
ingredients
1
2.
3.
4.
5.
6.
7.
8.
9.
Amlodipine
Starch
Microcrystalline cellulose
Hydroxpropyl cellulose
Hydropromellose
Starch
Silicon dioxide
Magnesium stearate
lactose
Total.
Mat
code
T12001
T12003
T12053
T12008
T12001
T12009
T12009
T12002
Qty for
batch
(kg)
7.50_
112.00
75.00
75.00
1.20
6.60
6.00
97.50
97.50
383.8
Bal.
No
Gross
Wt.
(kg)
Tare
Wt
(kg)
Net
Wt
(kg)
Wtd
by
Chkd.
By
UNICURE PHARMACEUTICAL LIMITED
Batch manufacturing Record
Product: Page 4 of 27
Date:
B.M.R. No:
AMLODIPINE
Batch size:
Specification:
Batch no:
1.5 MILLION
5mg
COATING (FILM COATING)
Bill of Raw Materials & weighing record
sr.
no
ingredients
1
2
3
4
5
6
Hypromellose
Macrogol-6000
Talcum powder
Purified water
Qty/
batch
(kg)
2.8
0.78
2.5
85.42
Bal. no
Gross Wt
(kg)
Requisition given by :
Area cleanliness
Production pharmacist:
Checked by :
Stores supervisor:
Previous product processed:
Material required on:
Calculation checked by:
Production:
Q.A.:
ATTACH DUPLICATE COPY OF WEIGHING SLIPS
Tare
Wt(kg)
Date:
Date:
Date:
B. No:
Issued on :
Date:
Date:
Ney Wt
(kg)
Weighed
by
Checked
by
UNICURE PHARMACEUTICAL LIMITED
Batch manufacturing Record
Product: Page 5 of 27
Date:
B.M.R. No:
AMLODIPINE
Batch size:
Specification:
Batch no:
NAME OF PRODUCT: Amlodipine besilate tablets (10mg)
Pretreatment Record
Line clearance type:
Same APL,
Has line clearance expired:
yes
no
Room :
FZB-300 milling machine
vibrating sieve,
Batch number:
Different APL,
Electronic balance
Operator :__________
checked by:__________
QA checked by:__________
The number of sieving mesh:__________________
Completeness test before operation of sieve circle in the the machine
complete incomplete
Checked by :_________________________
1.5 MILLION
5mg
date:_____________
date: ________________________
Pretreatment Record
Name of material
Manufacture SOP
1.5 million pieces
Amlodipine
Treatment (no mesh), 60
mesh
1.0 mm treatment ,
60mesh
Nylon treatment
,60mesh
Nylon screen treatment
80 mesh
Nylon screen treatment
60 mesh
Wire-mesh treatment,
20mesh
Wire-mesh treatment
,20 mesh
Wire-mesh treatment ,
20 mesh
Wire-mesh treatment ,
20mesh
7.50_
Starch
Microcrystalline cellulose
Hydropropyl cellulose
Hydromellose
Starch
Silicon dioxide
Magnesium stearate
lactose
Weight after
treatment(kg)
112.00
75.00
75.00
1.20
6.60
3.00
6.00
97.50
Operator: ____________ reviewed by:______________ QA checked by :____________ date:____________
Attach line clearance certificate of previous batch ( only for different API)
Actual yield rate %
UNICURE PHARMACEUTICAL LIMITED
Batch manufacturing Record
Product: Page 6 of 27
Date:
B.M.R. No:
No
Batch size:
Specification:
Batch no:
1.5 MILLION
5mg
Name of products: Amlodipine Besilate Tablets (10mg)
Batch number:
Material distributing record (divide the batch into 8 circle)
1st
Name of materials
Purpose
Theory Quality/per
2nd 3rd 4th
Quality in
(kg)
cycle
1
Amlodipine
2
3
starch
Microcrystalline
cellulose
Hydropropyl cellulose
Hydromellose
Starch
Silicon dioxide
Magnesium stearate
Lactose
4
5
6
7
8
9
10
11
12
AMLODIPINE
Total weight
Operator by/ date:
Weigh record
Rejected quantity : -------------kg
Yield rate standard (%)
Operator:_________
Active
7.50_
ingredient
112.0
75.00
1.86
Excipients
75.00
1.20
6.60
3.00
6.00
97.50
18.6
0.3
1.65
0.75
1.5
24.38
383.8
……………
…………….
94.86
Lubricant
5th
6th
7th
8th
28
18.6
reviewed by:
Actual yield rate (%)
workshop personnel:____________
Material balance
standard A (%)
99.00<A<101.00
Actual material balance (%)
QA personnel:______________ Date :_______________
UNICURE PHARMACEUTICAL LIMITED
Batch manufacturing Record
Product: Page 7 of 27
Date:
B.M.R. No:
AMLODIPINE
GRANULATING ROOM – line Clearance Record
Same APL:
Sr. Previous product:Operation
Batch
no
:
Completed
on:
No.
Sr. No.
Description
1.0
Batch size:
Specification:
Batch no:
Different
Date
& timeAPL
Time:
Remark From Checked To
by
yes/No
(prod)
PREPARATION OF GRANULATION SOLUTION
LabelPRODUCTION
(s) of previousBATCH
product
FOR ONE
Tablets/Granules
of
previous
Add 1.2g of Hypromellose to 1.2kgproduct
of hot purified water, stir evenly
Container(s)
of
previous
product
to make a slurry. Add slurry to 10kg of hot purified water and stir
Area
cleanliness(floor,
walls)
evenly.
Add
28.8kg of purified
water at room temperature to make a
Machinedivide
is ready
clean properly
40kgGrinding
binder solution.
intoand
8 portions.
Area
is
approved
for
operation
by Q.A.
Add 6.6kg of starch, add 19kg of purified
water at room
Temp. = with stirring
°C, Humidity
%RHwithout lumps. Add
temperature
to make=a solution
Clearance
is Satisfactory
not satisfactory.
boiling purified water up toLine
82.5kg
to make
starch slurry./ Divide
into
Line Cleared
By (prod.)
Date:
Time:
8 portion
Checked
by(QA):
Date:
Time:
Each
lot: Hypromellose 5kg
Starch 13.50kg
2.0
MIXING AND GRANULATION:
2.1
Transfer into cleaned RMG bowl raw material and excipients for lot.
2.2
Mix for 4 minutes atklklation of stage 2.1, in a thin stream into
mixer, while mixing at slow speed within 4 min. then mix for 3 min.
on fast speed. Scrape and mix for 1 min. with agitator and chopper
“ON” to get suitable consistency of granulation.
Continue the mixing further on slow speed.
Total mixing time----------------------Transfer the granules to FBD bowl through the discharge port. Keep
the agitator at slow speed & chopper in OFF position during
transferring the wet mass.
3.0
WET MASS MILLING:
Check the integrity of the sieve before & after of individual material.
Pass the wet mass at through oscillating granulator using MESH NO.
16 at medium speed.
1.
1.1 2.
3.
4.
5.
6.
7.
4.0
DRYING:
Dry the wet mass at stage 5.0 in a FBD at 70+ 2o c. for 10-15
minutes. Rake over intermittently so that all material in contact with
the screen is turned.
Inlet temperature:……………………….( < 85oc)
1.5 MILLION
5mg
Operation
Rechecked
Done
by by:
Chd. By
(QA)
UNICURE PHARMACEUTICAL LIMITED
Batch manufacturing Record
Product: Page 8 of 27
Date:
B.M.R. No:
AMLODIPINE
Batch size:
Specification:
Batch no:
1.5 MILLION
5mg
Outlet Temperature : ………………………(<60oc)
Total time taken for drying:……………………..
5.0
The drying is adequate when the LOD reaches 2.5 % or moisture content
2.0- 4.0 % at 70℃
SIZING & SIFTING:
Check the completeness of sieve before use
Grind the coarse material through oscillating granulator using 14 mesh
screen.
Redry if required and repeat stage
Note & record yield of dried granules
Std. yield: 99.50%, permissible yield: 99.00-100.00%
Attach weighing slips
Process sheet
Sr
Operation
No.
6.0
REWORKING:
Batch no:
Mfg. date:
Exp. Date:
Quantity
Date & time of operation
operation
From
Done by
To
Chd by
UNICURE PHARMACEUTICAL LIMITED
Batch manufacturing Record
Product: Page 9 of 27
Date:
B.M.R. No:
7.0
7.1
7.2
7.3
7.4
7.5
8.0
AMLODIPINE
Batch size:
Specification:
Batch no:
1.5 MILLION
5mg
The total qty. of reworking added should not exceed 5% of actual batch
size. The reworking to be added should be crushed through 2 mm
screen using the pin mill & sift through 20#. Add the reworking to the
bulk of blending. Reworking generated should be use within 3 month of
its generation.
LUBRICATION:
Transfer granules of stage 7.0 & reworking of stage 8.0 if any to the vblender by vacuum suction & mix for 5min.
Sift through 40# meshMagnesium stearate :4.8 kg
Transfer the lubricant of stage 9.2 to blend of 9.1 by sandwich method
& mix for 10 minutes.
Collect the lubricated granules in double polythene bag & record wt.
theoretical weight=………….kg + weight of reworking=…………kg
Std. yield : 99.50% permissible yield : 99.00-100.00%
SAMPLING: collect adequate samples at specified intervals as per SOP
and send to QC lab for in process testing.
Compression:
Compress the lubricated granules into tablets as per given specification.
Container
1.
2.
3.
4.
5.
6.
7.
8.
Gross wt.(kg)
Tare wt. (kg)
Net wt. (kg)
Signature
UNICURE PHARMACEUTICAL LIMITED
Batch manufacturing Record
Product: Page 10 of 27
Date:
B.M.R. No:
AMLODIPINE
Batch size:
Specification:
Batch no:
1.5 MILLION
5mg
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
Signature Of Production Pharmacist: _______________
Lubricated Granules output: ------------------
date: ______________
Balance ID No: -----------------
Yield Rate of Granulation and Material Balance (unit: kg)
Yield rate(%)= __________total weight of granules ×100%_______
Total weight of raw materials and excipients
Material balance e (%) = total dry granules weight + rejected quantity + Sampling quantity×100%
Total weight of raw materials and excipients
Line clearance Record ( compression)
Tablet compression machine – Line Clearance Record
Previous product compressed:
Batch no:
completed on:
Sr.
Description
No.
1.
Label (s) of previous product
2.
Tablets/Granules of previous product
Remark
yes/No
time:
Checked by
(prod)
Rechecked by:
(QA)
UNICURE PHARMACEUTICAL LIMITED
Batch manufacturing Record
Product: Page 11 of 27
Date:
B.M.R. No:
AMLODIPINE
Batch size:
Specification:
Batch no:
3.
Container(s) of previous product
4.
Area cleanliness(floor, walls)
5.
compression Machine is adjusted properly
6.
Area is approved for operation by Q.A.
7.
Temp. =
c, Humidity =
%RH
Line Clearance is Satisfactory / not satisfactory.
no
Line Cleared by (prod.)
Date:
Checked by(QA):
Date:
1.5 MILLION
5mg
Line clearance expired: yes
Time:
Time:
Attach line clearance certificate
Container
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
Net wt./kg)
Signature/Time
Container
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
Total :
Net wt. (kg)
Machine used
Operator
Last product processed:
Cleanliness check on the machine
B. No:
& area
Punches and dies appearance
Cleanliness check for punches
Balance check
Shift
date
Time started
Description compressed tablets: round, white to off white tablets
Signature/Time
UNICURE PHARMACEUTICAL LIMITED
Batch manufacturing Record
Product: Page 12 of 27
Date:
B.M.R. No:
AMLODIPINE
Batch size:
Specification:
Batch no:
1.5 MILLION
5mg
R
STD
UNITS
0.3989/tablet
7.978g±2.0 %
grams
3.0 7
̴ .0
+4.12
NMT 15
NMT 1.0
Kg/cm2
mm
Min
%
PERIODIC CHECKS AT COMPLETE ROTATION
SR
NO.
1.
2.
3.
4
5.
6.
7.
8.
9.
10.
11.
OPERATION
L
Setting of machine
Checking complete rotation
Weight adjustment: per Tablet
20 tablets
Appearance
Hardness
Thickness
Disintegration time
Friability (wt. of Tabs.
Corresponding about 6.5
gm.) Before rotation
Machine speed
Temperature
Humidity
SIGNATURE
10~22 R.P.M.
18~28OC
55-65%
Attach duplicate copy of previous line clearance certificate. (only for different API.)
TABLET COMPRESSION RECORD
NAME OF PRODUCT_______________________ A VERAGE WEIGHT RANGE_____________________
Specification: _________
Batch No: ____________
Room No: _____________
Date: ________________
: _____________________
Operator: _______________
UNICURE PHARMACEUTICAL LIMITED
Batch manufacturing Record
Product: Page 13 of 27
Date:
B.M.R. No:
Sr.
No
AMLODIPINE
Batch size:
Specification:
Batch no:
1.5 MILLION
5mg
Left
Time
Right
Mach
No.
Individual wt.
0.3989g/Tab.
Thickness
<4.12
Time
Mach
Individual wt.
No.
0.3989g/Tab.
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
Name of Product: Metformin HCL Tablets(500mg)
Batch Size: 1.5million pieces
Die Specification:
Speed: 12- 22
rpm
Hardness standard:
>3kg
Thickness standard:
<5.68mm
Tablets Weight in theory :
Batch Number:
Compressing Date:
Machine No:
Operator:
Average tablets weight range:
Shift:
Room No:
Thickness
<4.12
UNICURE PHARMACEUTICAL LIMITED
Batch manufacturing Record
Product: Page 14 of 27
Date:
B.M.R. No:
AMLODIPINE
Batch size:
Specification:
Batch no:
1.5 MILLION
5mg
Upper limit of average tablets weight
Lower limit of average tablets weight
Unit: g
Every block in ordinate equals……………..mg
every 2 blocks in abscissa equals ………………… minutes
DISINTEGRATION TEST RECORD
(Disintegration machine No ___________________)_
Disintegration time limit standard: _______________________Test time: ________________________ Test result: ______________ minutes
WEIGHT DIFFERENCE : standard limit+ 4.5%
Average Weight:
Weight Differences:
Test Time:
TABLET COMPRESSION RECORD
NAME OF PRODUCT_______________________ A VERAGE WEIGHT RANGE_____________________
Specification: _________
Batch No: ____________
Room No: _____________
Date: ________________
: _____________________
Operator: _______________
UNICURE PHARMACEUTICAL LIMITED
Batch manufacturing Record
Product: Page 15 of 27
Date:
B.M.R. No:
Sr.
No
AMLODIPINE
Batch size:
Specification:
Batch no:
1.5 MILLION
5mg
Left
Time
Right
Mach
No.
Individual wt.
0.3989g/Tab.
Thickness
<4.12
Time
Mach
Individual wt.
No.
0.3989g/Tab.
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
Name of Product: Metformin HCL Tablets(500mg)
Batch Number:
Batch Size: 1.5million pieces
Die Specification:
Compressing Date:
Speed: 12- 22
rpm
Machine No:
Hardness standard:
>3kg
Operator:
Thickness standard:
<5.68mm
Shift:
Room No:
Thickness
<4.12
UNICURE PHARMACEUTICAL LIMITED
Batch manufacturing Record
Product: Page 16 of 27
Date:
B.M.R. No:
AMLODIPINE
Tablets Weight in theory :
Upper limit of average tablets weight
Batch size:
Specification:
Batch no:
1.5 MILLION
5mg
Average tablets weight range:
Lower limit of average tablets weight
Unit: g
Every block in ordinate equals……………..mg
every 2 blocks in abscissa equals ………………… minutes
DISINTEGRATION TEST RECORD
(Disintegration machine No ___________________)_
Disintegration time limit standard: _______________________Test time: ________________________ Test result: ______________ minutes
WEIGHT DIFFERENCE : standard limit+ 4.5%
Average Weight:
Weight Differences:
Test Time:
TABLET COMPRESSION RECORD
Specification: _________
Batch No: ____________
Room No: _____________
UNICURE PHARMACEUTICAL LIMITED
Batch manufacturing Record
Product: Page 17 of 27
Date:
B.M.R. No:
AMLODIPINE
Date: ________________
Batch size:
Specification:
Batch no:
: _____________________
1.5 MILLION
5mg
Operator: _______________
NAME OF PRODUCT_______________________ A VERAGE WEIGHT RANGE_____________________
Sr.
No
Left
Time
Right
Mach
No.
Individual wt.
0.3989g/Tab.
Thickness
<4.12
Time
Mach
Individual wt.
No.
0.3989g/Tab.
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
Name of Product: Metformin HCL Tablets(500mg)
Batch Number:
Batch Size: 1.5million pieces
Die Specification:
Compressing Date:
Speed: 12- 22
rpm
Machine No:
Shift:
Room No:
Thickness
<4.12
UNICURE PHARMACEUTICAL LIMITED
Batch manufacturing Record
Product: Page 18 of 27
Date:
B.M.R. No:
AMLODIPINE
Hardness standard:
>3kg
Thickness standard:
<5.68mm
Tablets Weight in theory :
Upper limit of average tablets weight
Batch size:
Specification:
Batch no:
1.5 MILLION
5mg
Operator:
Average tablets weight range:
Lower limit of average tablets weight
Unit: g
Every block in ordinate equals……………..mg
every 2 blocks in abscissa equals ………………… minutes
DISINTEGRATION TEST RECORD
(Disintegration machine No ___________________)_
Disintegration time limit standard: _______________________Test time: ________________________ Test result: ______________ minutes
WEIGHT DIFFERENCE : standard limit+ 4.5%
Average Weight:
Weight Differences:
Weight Variation Record
Machine ID No:__________
Date:_________________
Balance ID No:
Shift:____________________ Wt. variation Limit: +2.5 % of Avg. Wt.
Test Time:
UNICURE PHARMACEUTICAL LIMITED
Batch manufacturing Record
Product: Page 19 of 27
Date:
B.M.R. No:
Wt. of 20 Tablets
Wt. wt. of Tab
Time in hours
Weight of individual Tablets in mg.
AMLODIPINE
g
Mg
g
Mg
Batch size:
Specification:
Batch no:
g
Mg
g
Mg
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
Max. Wt.
Allowed
Actual
Min. Wt.
Allowed
Actual
FRIABILITY TEST:
Wt. of Tabs
Corresponding about 6.5
gm. Before Rotation
Wt. of Tabs. After 100
Rotations
% loss
Sign.
Date
QA In process control report
Balance ID No:
Date of Compression
Shift
g
Mg
1.5 MILLION
5mg
g
Mg
g
Mg
g
Mg
g
Mg
UNICURE PHARMACEUTICAL LIMITED
Batch manufacturing Record
Product: Page 20 of 27
Date:
B.M.R. No:
AMLODIPINE
Batch size:
Specification:
Batch no:
Mach. Used
No. of punches
Theoretical weight
of 20 Tablets
Time
Actual wt. of
20
Tablets
L
R
1.5 MILLION
5mg
Operator
Punches used
Wt. variation limit
Disintegration
Time
Hardness
Thickness
NMT 15 min.
NLT 3~7kg./cm2
< 4.12
L
L
R
R
L
±2% OF 20 TABLETS
Operator
R
Check & record the weight of 20 tablets every 15 minutes.
Check & record the average hardness of 3 tablets & average thickness of 3 tablets every 30 mins.
Check & record the D.T. of 6 tablets, weight variation & friability of tablet every 2 hours.
Balance ID No:
Chd. By
UNICURE PHARMACEUTICAL LIMITED
Batch manufacturing Record
Product: Page 21 of 27
Date:
B.M.R. No:
Container
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
25.
26.
27.
28.
29.
30.
AMLODIPINE
Gross wt. (kg)
Batch size:
Specification:
Batch no:
Tare wt. (kg)
Net wt. (kg)
1.5 MILLION
5mg
Sign
UNICURE PHARMACEUTICAL LIMITED
Batch manufacturing Record
Product: Page 22 of 27
Date:
B.M.R. No:
AMLODIPINE
Total wt in kg:
Batch size:
Specification:
Batch no:
1.5 MILLION
5mg
No of tablets:
Theoretical yield :……………………………..kg + Reworking added:………………………kg.
Total yield:………………………..
Yield standard :99.00% Actual yield :…………………………
Material Balance
Compressed tablet yield rate and material balance calculation
Material balance equation (%)= total tablets weight + rejected quantity + sampling quantity
×100%
Total weight of granules
Yield rate = total tablets weight ×100%
Total weight of granules
To be filled by Quality Assurance (Uncoated Tablets)
Appearance of the tablet
Average weight of the tablet: …………..mg.
Hardness = ……………………….kg/cm2
Disintegration time = …………..min
Thickness = ………mm.
Friability = …………
Date of manufacturing :
Remarks:
Approved / Not Approved for further processing
Analyst:
Date:
Date of expiry :
UNICURE PHARMACEUTICAL LIMITED
Batch manufacturing Record
Product: Page 23 of 27
Date:
B.M.R. No:
AMLODIPINE
Tablet Coating – Line Clearance Record
Previous product compressed:
Batch No:
Completed on:
Sr. No.
Description
Batch size:
Specification:
Batch no:
Shift
Remark
Yes/No
1.5 MILLION
5mg
Time:
Checked
by (prod)
Rechecked
by ( Q.A.)
1.
2.
3.
4.
5.
Label (s) of previous product
Tablets/Granules of previous product
Container(s) of previous product
Area cleanliness(floor, walls)
Coating Machine is operational and properly
cleaned
6.
Batch is approved for operation by Q.A.
7.
Temp. = ℃, Humidity =
% RH
Line Clearance is Satisfactory / not satisfactory.
Line Cleared by (prod.)
Date:
Time:
Checked by(QA):
Date:
Time:
Process Sheet (Coating)
Sr. No.
11.0
11.1
11.2
12.0
12.1
Operation
Preparation of coating solution:
Under constant mechanical stirring disperse by sprinkling,
In 95% ethanol 300kg, of Orange colored coating material: 24kg
Then add 0.462kg purified water .
Stir for 10 minutes to get a homogeneous slurry.
Filter the solution through 200# nylon cloth and weigh
Coating
Load the dedusted & inspected core tablets into a clean, dry
S.S. coating pan.
Date &time of
operation
From
To
Operation
Done
by
Chd. By
UNICURE PHARMACEUTICAL LIMITED
Batch manufacturing Record
Product: Page 24 of 27
Date:
B.M.R. No:
12.2
12.3
12.4
12.5
12.6
12.7
12.8
AMLODIPINE
Batch size:
Specification:
Batch no:
ADJUST:
RPM of coating pan ( 4- 8 RPM)
Temperature of hot air blower: 45 – 55oc.
Air pressure: 0.4 – 0.5 MPa
Peristaltic pump: 70 to 80 RPM
Apply the film coating solution to tablets using a clean spray
gun assembly.
After completion of coating rotate the pan for drying the
tablets in pan for 10 minutes at 40oc.
At the end of coating, record weight of 100 tablets. Collect
the tablet in double polyethylene bags.
Intimate Q.A. Department to collect the representative
sample for testing.
Check & record net weight of coated tablet. Keep the bag
tightly closed with proper labels.
Before taking tablets for packing, inspect the tablet for
spotted appearance, black specs, broken & chipped tablet.
Segregate the rejection as reusable and to be destroyed,
separated & note down the weights. Accordingly & store the
tablets in double polythene bags.
………RPM
……………oc
…………kg./cm2
…………..RPM
Time
From:
To:
Temp………..oc
Wt.:…………gm
Wt.:…………kg
1.5 MILLION
5mg
UNICURE PHARMACEUTICAL LIMITED
Batch manufacturing Record
Product: Page 25 of 27
Date:
B.M.R. No:
AMLODIPINE
Batch size:
Specification:
Batch no:
1.5 MILLION
5mg
Coated tablet check
Appearance:
Weight. of 100 tablets:
……………………..gm.
Standard
/Tab + 5.0 % w/w
NMT 15 minutes.
<4.12 mm
Average weight:
Disintegration time :
Thickness:
Check by & Date :
Observed
Tablet Output Form (Coated)
Balance ID No:
Container No.
Gross wt.(Kg.)
Tare wt. (Kg.)
Net wt.(Kg.)
Sign.
1.
2.
3.
4.
5.
6.
7.
8.
Total wt in kg:………….
Yield Standard : 99.00%
Check by:
No of tablets:…………………
Actual yield :………………..
QA………………………….
Total Theoretical yield :…………….
Date:…………………………………..
Inspection ( Coated Tablets)
Inspect the tablet for black spots, foreign particles, chipped or broken tablets. Etc.
A
Record the weight of rejected tablets i.e. black spots, foreign particles, chipped or broken tablets and put in
water for destruction.
Weight of tablets=………………kg
B
Chipped and broken tablets, generated during coating can be used as utilizable residue in next batch.
Transfer the inspected tablets to double polythene bags inside the suitable airtight contains.
Record the weight of inspected tablets.
Weight of tablets= ………………..kg
Tablet inspection and rejection record (coated)
Area clearance checked by:
Date:
Shift:
Previous product processed: B.
No:
Production pharmacist –
Q.A. chemistTimeFrom:
Date – Date
To
UNICURE PHARMACEUTICAL LIMITED
Batch manufacturing Record
Product: Page 26 of 27
Date:
B.M.R. No:
AMLODIPINE
Batch size:
Specification:
Batch no:
Total weight of tablets received for inspection= …………………. Kg.
Inspection carried out by :
Wt. of tablets after inspection :………………………
Balance ID No:
Container No. Gross wt.
Tare wt. Net wt.
Kg.
Kg.
Kg.
1.
2.
3.
4.
5.
6.
7.
8.
1.5 MILLION
5mg
Sign
Total wt: ………………..
A) Reusable :…………………………kg
No of Tablets: …………………….
B) Rejects to be destroyed : ……………….kg.
No of tablets: …………………….
Pharmacist :
Date :
Rejection & Destruction Record
Qty. destroyed
Rejection generated during tablet compression/inspection
Destruction witnessed by:
Production pharmacistQ.A. Chemist-
Date –Date
Batch Reconciliation Data
Manufacturing
Date of manufacturing:
Standard Batch Size =…………………kg.
Reworking added =……………
Theoretical Yield =………………..
Actual Yield =…………………..kg
= …………………….%
Variance = ……………..kg
Pharmacist signature:
Date:
Method used
Compression
Date of compression:
Compression wt. =…………………………..mg
Actual Yield (A)=……………………………kg.
=…………………. Tablets
Reworking generated (B)= ………………
Theoretical Yield (T) = …………………….
Total Yield (A+B) =……………………kg.
% yield = (A+B) / T X 100 = ………….%
Variance = …………………kg.
Pharmacist signature :
Date:
UNICURE PHARMACEUTICAL LIMITED
Batch manufacturing Record
Product: Page 27 of 27
Date:
B.M.R. No:
AMLODIPINE
Batch size:
Specification:
Batch no:
1.5 MILLION
5mg
Yield statement
Sr.
No.
STATE OF OPERATION
INPUT
(KG)
A
ACTUAL
WT. KG
B
PERCENTAGE
(%)
B/A X 100
STD.
YIELD (%)
PERMISSIBLE YIELD
(%)
LOWER
1.
2.
3.
4.
Dried Granules
Lubricated granules
Compressed tablets
Coated Tablet
Checked by :
Date:
History of Change
Sr.
No.
Revision No./ Date
1.
This Document supersedes
N.A.
Reason for change
New
HIGHER