BATCH MANUFACTURING RECORD

PRODUCT NAME AROFLAM BMR No. AP/AGT017

PRODUCT CODE AGT017 REV. No. 002
Batch No. BA Batch Size 150000 Tablets
Mfg. Date Exp. Date
Page No: 1 of 13
PREPARED BY CHECKED BY APPROVED BY
SIGNATURE
NAME Aarati Karki Sunil Panjiyar Nishant Kumar Gupta
DESIGNATION Q.A. OFFICER PRODUCTION MANAGER Q.A. MANAGER
DATE 15/01/2021 15/01/2021 15/01/2021

SECTION: TABLET
INFORMATIONS
Product Name AROFLAM
Generic Name Ibuprofen & Paracetamol Tablets IP
Product Code AGT017
Each Uncoated tablet contains:
Composition Ibuprofen IP 400 mg
Paracetamol IP 500 mg
Batch No.: BA Batch Size: 150000 Tablets
Mfg. Date: Exp. Date
Issue Reference No:
Issued By (QA) Received By (Production)
Group GA
MRP Rs.20/-Per 10 Tablets
Pack Size- 20 X 10
Manufacturing License No. 1760512073134
BMR Record No. AP/AGT017
Shelf Life 24 months
Standard Batch Size 150000 Tablets
Arrow Pharmaceutical Pvt. Ltd.,
Manufacturing by & Location
Changunarayan-08, Bhaktapur, Nepal
BMR Effective Date 01/2021
Prevent cross contamination, unnecessary inhalation of the dust should be
Precaution
avoided. Use protective clothing masks and gloves while working.
Date of Commencement
Date of Completion
 BATCH MANUFACTURING RECORD
PRODUCT NAME AROFLAM BMR No. AP/AGT017
PRODUCT CODE AGT017 REV. No. 002
Batch No. BA Batch Size 150000 Tablets
Mfg. Date Exp. Date
Page No: 2 of 13
PREPARED BY CHECKED BY APPROVED BY
SIGNATURE
NAME Aarati Karki Sunil Panjiyar Nishant Kumar Gupta
DESIGNATION Q.A. OFFICER PRODUCTION MANAGER Q.A. MANAGER
DATE 15/01/2021 15/01/2021 15/01/2021

1. INSTRUCTIONS & PRECAUTIONS :

a. Read this Instructions & Precautions before putting Batch Manufacturing Record (BMR) in
practice.
b. Maintain the high degree of cleanliness and sanitation throughout the process.
c. Follow the laid down cleaning procedures, operation procedures and safety procedures at all times.
d. Follow the process instruction at all times and record information as prescribed in the process.
e. Maintain Temperature 250 ± 20 C and Relative Humidity 45 ± 5% throughout the process.
f. Avoid holding of semi-finished product during weekend or holiday.
g. Crosscheck the Raw Materials before commencement.
h. Use only tagged Raw Materials.
i. Wear proper protective clothing at all times.
j. Keep hands away from the rotating machine.
k. Maintain the specified pressure differential in the adjacent corridor and manufacturing area.
l. Before starting any operation Line Clearance is a must.
m. Check the cleanliness of the containers in which bulk material is to be kept.

Verify cleaning of the equipments & dispensing area as per respective SOP’s for line clearance before
starting of the dispensing.
2. LINE CLEARANCE CHECKLIST FOR DISPENSING AREA
S.N. ACTIVITY (YES/NO REMARKS SIGN
/NA)
1 Dispensing booth & equipments are clean and dust free.
2 Weighing balance is calibrated.
3 All types of wastages are removed from dispensing area.
4 All Raw Materials of previous products are removed from
dispensing area.
5 Containers and other equipments used for weighing and
transferring the material are clean and dry.
6 ……..mm of
Check and ensure that LAF of the dispensing booth is on
water column
Limit:10 to 15mm of water column.
………. 0C
Check the temperature and RH of the dispensing area is on
…… Pascal
Limit: 250 ± 20 C and 45 ± 5% respectively.
……..RH
7 Materials are brought in original pack of dispensing and
verified for FIFO system and Q.C. approval lebels.
8 Check whether the R. M. Requisition Sheet is ready and
signed by authorized person

…………………….. ……………………
Production Pharmacist Q.A. Pharmacist
 BATCH MANUFACTURING RECORD
PRODUCT NAME AROFLAM BMR No. AP/AGT017
PRODUCT CODE AGT017 REV. No. 002
Batch No. BA Batch Size 150000 Tablets
Mfg. Date Exp. Date
Page No: 3 of 13
PREPARED BY CHECKED BY APPROVED BY
SIGNATURE
NAME Aarati Karki Sunil Panjiyar Nishant Kumar Gupta
DESIGNATION Q.A. OFFICER PRODUCTION MANAGER Q.A. MANAGER
DATE 15/01/2021 15/01/2021 15/01/2021

RAW MATERIAL WEIGHT CHECKING

a) After Line Clearance of Dispensing Area cross check the area, dispense the raw material as per raw material
requisition slip.
b) Check Store's Tags on each raw material with respect to 'Product Name', 'Material's Name', 'Batch No.', 'QC AR
No.' & 'Qty. against Requisition of Raw Material', 'Batch Formula', 'Mfg. Date' & 'Exp. Date' of Raw Materials.
c) Initial the tag and BMR with date on verification. Attach all raw material tags to BMR, covering them together
in a poly bag.

RAW MATERIAL WEIGHT CHECKING (Production Copy)

Specifi Label QTY. /BATCH
S. cation Claim QTY/TAB Qty.
RAW MATERIAL 150000 A. R. NO.
N. (mg) Unit Disp.

Paracetamol
1 IP 500 mg 500 75 Kg
Potency:
Ibuprofen
2 IP 400 mg 400 60 Kg
Potency:
Sodium Starch
3 IP 25 3.75 Kg
Glycollate
4 Croscarmellose Sodium IP 20 3.00 Kg
5 Aerosil IP 10 1.50 Kg
6 Sodium Thiosulphate IP 2 0.30 Kg
7 Starch (For Paste) IP 50 7.50 Kg
8 Purified Water IP 300 45 Kg
Lubrication
9 Aerosil IP 10 1.50 Kg
10 Magnesium Stearate IP 10 1.50 Kg
11 Purified Talc IP 15 2.25 Kg
12 Croscarmellose Sodium IP 20 3.00 Kg
Sodium Starch
13 IP 25 3.75 Kg
Glycollate
Total Weight 1087 mg 163.05 Kg

Weigh By 1. ……………… 2. ……………….. Dispensed By …………………………

Checked By (Production)………………………. Checked By (QA)…………………….

 BATCH MANUFACTURING RECORD
PRODUCT NAME AROFLAM BMR No. AP/AGT017
PRODUCT CODE AGT017 REV. No. 002
Batch No. BA Batch Size 150000 Tablets
Mfg. Date Exp. Date
Page No: 3 of 13
PREPARED BY CHECKED BY APPROVED BY
SIGNATURE
NAME Aarati Karki Sunil Panjiyar Nishant Kumar Gupta
DESIGNATION Q.A. OFFICER PRODUCTION MANAGER Q.A. MANAGER
DATE 15/01/2021 15/01/2021 15/01/2021

RAW MATERIAL WEIGHT CHECKING (Store Copy)

Specifi Label QTY. /BATCH
S. cation Claim QTY/TAB Qty.
RAW MATERIAL (mg) A. R. NO.
N. 150000 Unit Disp.

Paracetamol
1 IP 500 mg 500 75 Kg
Potency:
Ibuprofen
2 IP 400 mg 400 60 Kg
Potency:
3 Sodium Starch Glycollate IP 25 3.75 Kg
4 Croscarmellose Sodium IP 20 3.00 Kg
5 Aerosil IP 10 1.50 Kg
6 Sodium Thiosulphate IP 2 0.30 Kg
7 Starch (For Paste) IP 50 7.50 Kg
8 Purified Water IP 300 45 Kg
Lubrication
9 Aerosil IP 10 1.50 Kg
10 Magnesium Stearate IP 10 1.50 Kg
11 Purified Talc IP 15 2.25 Kg
12 Croscarmellose Sodium IP 20 3.00 Kg
13 Sodium Starch Glycollate IP 25 3.75 Kg
Total Weight 1087 mg 163.05 Kg

Weigh By 1. ……………… 2. ……………….. Dispensed By …………………………

Checked By (Production)………………………. Checked By (QA)…………………….

 BATCH MANUFACTURING RECORD
PRODUCT NAME AROFLAM BMR No. AP/AGT017
PRODUCT CODE AGT017 REV. No. 002
Batch No. BA Batch Size 150000 Tablets
Mfg. Date Exp. Date
Page No: 4 of 13
PREPARED BY CHECKED BY APPROVED BY
SIGNATURE
NAME Aarati Karki Sunil Panjiyar Nishant Kumar Gupta
DESIGNATION Q.A. OFFICER PRODUCTION MANAGER Q.A. MANAGER
DATE 15/01/2021 15/01/2021 15/01/2021

3. LIST OF EQUIPMENTS AND THEIR CLEANING RECORD :

Equipment Previous Product Cleaning Date of Cleaned Checked By
S.N. Name of Equipment
Code No. & Batch No. SOP No. Cleaning By Prodn. Q.A.
AP/WI/QA/T-
1 Sifter AP/G/M005 303
AP/WI/QA/T-
2 RMG AP/G/M007 307
AP/WI/QA/T-
3 Multi Mill AP/G/M009 305
AP/WI/QA/T-
4 Co-Mill AP/G/M008 315
AP/WI/QA/T-
5 Fluidized Bed Dryer AP/G/M006 317
AP/WI/QA/T-
6 Octagonal Blender AP/G/M012 333
Rotary Tablet AP/WI/QA/T-
7 AP/G/M0
Compression Machine

4. LINE CLEARANCE CHECKLIST FOR GRANULATION AREA

S. N. Activity (Yes/No/NA ) Remarks Signature
1. Ensure cleanliness of manufacturing area and equipment’s.
Conduct visual inspection of all equipment required for
2. manufacturing process and cross check the equipment
cleaning record for line clearance.
Ensure that previous products granules / blend are removed
3.
from granulation area
All types of wastages are removed from granulation
4.
area
5. All equipment/machinery are properly cleaned as per SOP.
All equipment/machinery are properly fixed & observed for
6.
perfect working order as per SOP.
7. Air handling system is properly working.
GRANULATION AREA IS CLEARED FOR PROCESSING THE ABOVE PRODUCT/ BATCH
…………………….. ……………………
Production Pharmacist Q.A. Pharmacist

5. VERIFICATION OF RAW MATERIALS :

5.1. Check Store's tag on each raw material with respect to Product Name, Material's Name, Batch Number, A. R.
No. & Quantity against Operational Raw Material List, Mfg. date & Exp. Date of Raw materials
5.2. Initial the tag and BMR with date on verification.
5.3. Attach all Raw Material tags to BMR, covering them together in a magic seal.

….……………….
Production Pharmacist Date: …………………….
Manufacturing Process Checked Counter
 BATCH MANUFACTURING RECORD
PRODUCT NAME AROFLAM BMR No. AP/AGT017
PRODUCT CODE AGT017 REV. No. 002
Batch No. BA Batch Size 150000 Tablets
Mfg. Date Exp. Date
Page No: 5 of 13
PREPARED BY CHECKED BY APPROVED BY
SIGNATURE
NAME Aarati Karki Sunil Panjiyar Nishant Kumar Gupta
DESIGNATION Q.A. OFFICER PRODUCTION MANAGER Q.A. MANAGER
DATE 15/01/2021 15/01/2021 15/01/2021

by: Checked by:

Date: RH % Temp ºC DP Pa
STEP 6 Granulation
6.1 Sifting
Equipment: Vibro Sifter
Equipment No: AP/G/M005
Pass the following ingredients through 60mesh sieve size in sifter and collect on double poly
bags respectively.
Ingredient Actual Qty Mesh size
Lot A Lot B Lot C used
Paracetamol
Ibuprofen
Sodium Starch Glycollate
Croscarmellose Sodium
Aerosil
Lot A From:………………... To:………….….. Total time:……………
Lot B From:………………... To:………….….. Total time:……………
Lot C From:………………... To:………….….. Total time:……………
Operator:………………
6.2 Mixing
Transfer all Sifted materials in to RMG and mix it for 15 minutes.
Lot A From:………………... To:………….….. Total time:……………
Lot B From:………………... To:………….….. Total time:……………
Lot C From:………………... To:………….….. Total time:……………
6.3 Binder Solution Preparation
Dissolve Sodium Thiosulphate in purified water.
Disperse Starch for paste in remaining Hot water to form Starch paste.
Water Required for Lot A ………………..Lot B …………….Lot C……………….

6.4 Wet Granulation

Granulate Step 6.2 mixture with step 6.3 binder solution in RMG until granulation is
completed.
Lo Impellar Chopper Impellar Run Time Chopper Run Time Additional Total
t speed speed Start Stop Total Start Stop Total water water
used used
A
B
C

Operated By: …………………

Manufacturing Process Checked Counter
by: Checked by:
 BATCH MANUFACTURING RECORD
PRODUCT NAME AROFLAM BMR No. AP/AGT017
PRODUCT CODE AGT017 REV. No. 002
Batch No. BA Batch Size 150000 Tablets
Mfg. Date Exp. Date
Page No: 6 of 13
PREPARED BY CHECKED BY APPROVED BY
SIGNATURE
NAME Aarati Karki Sunil Panjiyar Nishant Kumar Gupta
DESIGNATION Q.A. OFFICER PRODUCTION MANAGER Q.A. MANAGER
DATE 15/01/2021 15/01/2021 15/01/2021

6.5 Wet Passing

Pass the wet dough mass of step no. 6.4 through Comill using #8 sieve.
Lot A From:………………... To:………….….. Total time:……………
Lot B From:………………... To:………….….. Total time:……………
Lot C From:………………... To:………….….. Total time:……………
6.5 Semi Drying
Load granules in FBD and dry the materials at 50-55°C till moisture content comes to 6 to 8%.
Lot Start time Stop time Total time Operator
A
B
C
D
E
F

6.6 Rasping
Pass the semi dried granules through #16 mesh
Lot Start time Stop time Total time Operator
A
B
C
D
E
F
6.7 Final Drying
Final dry it in FBD at 55° C till moisture content fall to 3 to 4 %. Pass the dried granules
through #16 mesh.
Lot Start time Stop time Total time Moisture Operator
content(%)
A
B
C
D
E
F
6.8 Final Sieving
Pass the dried granules through #16 mesh.
From:………………... To:………….….. Total Time:……………

STEP 7
Lubrication
Equipment: Octagonal Blender
Equipment No: AP/G/M012 Cleaned by: _________
Check Line clearance of Lubrication area.
 BATCH MANUFACTURING RECORD
PRODUCT NAME AROFLAM BMR No. AP/AGT017
PRODUCT CODE AGT017 REV. No. 002
Batch No. BA Batch Size 150000 Tablets
Mfg. Date Exp. Date
Page No: 7 of 13
PREPARED BY CHECKED BY APPROVED BY
SIGNATURE
NAME Aarati Karki Sunil Panjiyar Nishant Kumar Gupta
DESIGNATION Q.A. OFFICER PRODUCTION MANAGER Q.A. MANAGER
DATE 15/01/2021 15/01/2021 15/01/2021

Previous Product: ………………………….. Batch No: ……………………

……………………… …………………
Production Pharmacist QA Pharmacist

7.1 Pass the following ingredients through 60 mesh sieve size in sifter and collect on double
poly bags.
Ingredient Actual Qty.(kg) Mesh size used
Aerosil
Magnesium Stearate
Purified Talc
Croscarmellose Sodium
Sodium Starch Glycollate

7.2 Addition Of Recoverable Rejection (If Any)

R.R. Batch No.: Batch Size:
Mfg. Date: Exp. Date:
Recoverable qty storage period: From: to: ( Days)
Recoverable qty to be added: ………… Kg

Recovered tablets/granules during adjustment of weight at the starting of compression and de-
blistered tablets at the packing stage can be incorporated in a fresh batch as per SOP No
…………...
Such addition of recoverable rejection must be done after thorough inspection of the recovered
tablets in presence of Production Executive & IPQC personnel. Recovered tablets are to be
passed through multimill fitted with 2.00 mm screen or through comill fitted with 4 mm screen
followed by sifting through #16 sieve to obtain granules/powder and added to the fresh
lubricated granules.

(NOTE: QUANTITY OF THE RECOVERABLE ADDED SHOULD NOT BE MORE

THAN 5 % OF STANDARD BATCH SIZE)

7.3 Mix the dried granules from step 6, recovered granules from step 7.2 and lubricants from
step 7.1 in octagonal blender for 30 minutes.
Collect the lubricated granules in double polythene lined PVC drums and note the weight of
lubricated granules.
From:………………... To:………….….. Total time:……………
Operator:………………

Weight of Lubricated Granules

Container No Gross Wt. Tare Wt. Net Wt.

Total Wt.
 BATCH MANUFACTURING RECORD
PRODUCT NAME AROFLAM BMR No. AP/AGT017
PRODUCT CODE AGT017 REV. No. 002
Batch No. BA Batch Size 150000 Tablets
Mfg. Date Exp. Date
Page No: 8 of 13
PREPARED BY CHECKED BY APPROVED BY
SIGNATURE
NAME Aarati Karki Sunil Panjiyar Nishant Kumar Gupta
DESIGNATION Q.A. OFFICER PRODUCTION MANAGER Q.A. MANAGER
DATE 15/01/2021 15/01/2021 15/01/2021

Theoretical Weight: …………… Actual Weight: …………

%Yield:……….
Intimate the In-process Quality Control for sampling and complete Analysis of granules
through IPQC.
Sampled By………………….

Signature & Date: ……………….

Only after getting approval from Quality Control department for release of granules for
compression, transfer the granules for compression.
Release No. ……………………
Date: ………………………….
(Attach Quality Control Release Slip of granules for compression to BMR)
Date: RH % Temp ºC DP Pa
STEP 8
COMPRESSION:
Equipment: Compression machine
Equipment No: AP/CF/M009
Punch size: 19.5 mm Punch Shape: Oblong biconcave
8.1 Setting of Compression Machine :
Set Rotary Tablet Compression Machine (Code No. AP/CF/M009) with 19.50 mm Dies and
19.50 mm punches.

S.N. Change Parts Code No. Specification No.

I Upper Punch P/U12
II Lower Punch P/L12
III Dies P/D12

Setting Done By:

From :…………………….. To:………………………… Total :……………….

8.2 LINE CLEARANCE OF COMPRESSION AREA

Previous Product: ……………………. Room:………………..
Batch Number : ……………………. Date: …………………..
S. No. Activity Put (Yes/No Not Remarks Signature
 BATCH MANUFACTURING RECORD
PRODUCT NAME AROFLAM BMR No. AP/AGT017
PRODUCT CODE AGT017 REV. No. 002
Batch No. BA Batch Size 150000 Tablets
Mfg. Date Exp. Date
Page No: 9 of 13
PREPARED BY CHECKED BY APPROVED BY
SIGNATURE
NAME Aarati Karki Sunil Panjiyar Nishant Kumar Gupta
DESIGNATION Q.A. OFFICER PRODUCTION MANAGER Q.A. MANAGER
DATE 15/01/2021 15/01/2021 15/01/2021

applicable)
1 Containers of Tablets of previous product removed.
2 Previous product / Batch No. / Status Label removed.
3 Compression Machine is properly cleaned and dry.
All equipment / machinery are in perfect working order in
4
compression area
5 All types of wastages are removed from Compression area.
6 Compression area is cleaned and dusts free.
7 AHU is in proper working order.
8 All containers for use are properly cleaned.
COMPRESSION AREA IS CLEARED FOR PROCESSING OF THE ABOVE PRODUCT / BATCH

………………………. ……………….
Production Pharmacist Q.A. Pharmacist
 BATCH MANUFACTURING RECORD
PRODUCT NAME AROFLAM BMR No. AP/AGT017
PRODUCT CODE AGT017 REV. No. 002
Batch No. BA Batch Size 150000 Tablets
Mfg. Date Exp. Date
Page No: 10 of 13
PREPARED BY CHECKED BY APPROVED BY
SIGNATURE
NAME Aarati Karki Sunil Panjiyar Nishant Kumar Gupta
DESIGNATION Q.A. OFFICER PRODUCTION MANAGER Q.A. MANAGER
DATE 15/01/2021 15/01/2021 15/01/2021

8.3 DURING COMPRESSION CARRYOUT IN-PROCESS CHECK AS FOLLOW.

S. SPECIFICATION TIME
PARAMETERS
NO. MINIMUM STANDARD MAXIMUM INTERVAL
8.3.1 Weight of 20 Tablets 21.10 g 21.74 g 22.40 g Every 15 minutes
8.3.2 Weight Variation 1055 mg. 1087 mg. 1120 mg. Hourly
8.3.3 Hardness - NLT 2 kg/cm2 - Hourly
8.3.4 Friability - NMT 1% - Hourly
8.3.5 Thickness 6.3 mm 6.50 mm 6.70 mm Hourly
8.3.6 Disintegration Time - NMT 5 Minutes - Hourly
8.4 Progressive Report of Compression :
Weight Disintegration
Hardness Thickness Carried Checked
Date Time Hopper of 20 Time Friability
(Kp.) (mm) out By By
side Tablets (Minutes)

8.5 Weight Control Chart

Time

Target weight
 BATCH MANUFACTURING RECORD
PRODUCT NAME AROFLAM BMR No. AP/AGT017
PRODUCT CODE AGT017 REV. No. 002
Batch No. BA Batch Size 150000 Tablets
Mfg. Date Exp. Date
Page No: 11 of 13
PREPARED BY CHECKED BY APPROVED BY
SIGNATURE
NAME Aarati Karki Sunil Panjiyar Nishant Kumar Gupta
DESIGNATION Q.A. OFFICER PRODUCTION MANAGER Q.A. MANAGER
DATE 15/01/2021 15/01/2021 15/01/2021

Lower Control Limit Middle Control Limit Upper Control Limit

8.6 Weight Variation Limit
8.6.1. Date & Time: ……… Hopper side:
Weight of 20 tablets: ……..
Average weight of tablet: ……….

Maximum Variation ………… %

Minimum Variation …………% Signature ………………..
8.6.2. Date & Time: ……… Hopper side:
Weight of 20 tablets: ……..
Average weight of tablet: ……….

Maximum Variation ………… %

Minimum Variation …………% Signature ………………..
8.6.3. Date & Time: ……… Hopper side:
Weight of 20 tablets: ……..
Average weight of tablet: ……….

Maximum Variation ………… %

Minimum Variation …………% Signature ………………..
8.6.4. Date & Time: ……… Hopper side:
Weight of 20 tablets: ……..
Average weight of tablet: ……….

Maximum Variation ………… %

Minimum Variation …………% Signature ………………..

8.6.5. Date & Time: ……… Hopper side:

Weight of 20 tablets: ……..
Average weight of tablet: ……….

Maximum Variation ………… %

Minimum Variation …………% Signature ………………..
 BATCH MANUFACTURING RECORD
PRODUCT NAME AROFLAM BMR No. AP/AGT017
PRODUCT CODE AGT017 REV. No. 002
Batch No. BA Batch Size 150000 Tablets
Mfg. Date Exp. Date
Page No: 12 of 13
PREPARED BY CHECKED BY APPROVED BY
SIGNATURE
NAME Aarati Karki Sunil Panjiyar Nishant Kumar Gupta
DESIGNATION Q.A. OFFICER PRODUCTION MANAGER Q.A. MANAGER
DATE 15/01/2021 15/01/2021 15/01/2021

Manufacturing Process Checked Counter

by: Checked by:
Compressed tablets are collected in double polythene lined PVC drums.

From:………………… To……………………. Total:…………………………….

Weight of Compressed Tablets :
Container Gross Tare Wt. Net Wt.
No. Wt. (GW) (TW) (GW-TW)

Total
Theoretical Weight of Tablets …………

Practical Weight of Tablets ……………

% Yield ……… %
9. VISUAL INSPECTION
9.1 LINE CLEARANCE OF VISUAL INSPECTION OF UNCOATED TABLETS AREA.

Previous Product: ……………………. Room:………………..

Batch Number : ……………………. Date: …………………..

S. Put√/X/NA
Activity Remarks Signature
No. (Yes/No Not applicable)
1 Containers of Tablets of Previous product removed.
2 Previous product / Batch No. / Status Label removed.
3 Inspection Machine properly cleaned and dry.
All equipment / machinery are in perfect working order
4
in inspection area.
5 All types of wastages are removed from inspection area.
6 Inspection area is cleaned and dusts free.
7 AHU is in proper working order.
8 All containers for use are properly cleaned
VISUAL INSPECTION OF UNCOATED TABLETS AREA IS CLEARED FOR PROCESSING OF THE ABOVE PRODUCT / BATCH.

……………………. ……………….
Production Pharmacist Q.A. Pharmacist
 BATCH MANUFACTURING RECORD
PRODUCT NAME AROFLAM BMR No. AP/AGT017
PRODUCT CODE AGT017 REV. No. 002
Batch No. BA Batch Size 150000 Tablets
Mfg. Date Exp. Date
Page No: 13 of 13
PREPARED BY CHECKED BY APPROVED BY
SIGNATURE
NAME Aarati Karki Sunil Panjiyar Nishant Kumar Gupta
DESIGNATION Q.A. OFFICER PRODUCTION MANAGER Q.A. MANAGER
DATE 15/01/2021 15/01/2021 15/01/2021

Manufacturing Process Checked by: Counter

Checked by:
Date: RH % Temp ºC DP Pa
9.2 Visual Inspection of Uncoated Tablets:
Carry out visual inspection of each tablet to sort out any defects.
Quantity of defective tablets………… kg.
Nature Of Defects: ………………………
From:………………… To……………………. Total:…………………………….
Done By:……………………
Weight of uncoated Tablets :
Container Gross Tare Wt. Net Wt.
No. Wt. (GW) (TW) (GW-TW)

Total
Theoretical Yield: ……….. kg
Practical Yield ….……. kg
% Yield: …….

Deviation (If any):

Document attached with BMR

1. RM Requisition
2. RM dispensing card
3. Equipment cleaning record for line clearance
4. Equipment cleaning card
5. Bulk product analysis request memo
6. Bulk product analysis report
7. Short fall memo (if any)
8. Store return note (if any)
9. IPC Sheet Tablets
10. weight control chart
11. Deviation document (if any)

……………………….. ..…………………… …………… ……………..

Production Pharmacist Production Manager QA Officer QA Manager
 BATCH MANUFACTURING RECORD
PRODUCT NAME AROFLAM BMR No. AP/AGT017
PRODUCT CODE AGT017 REV. No. 002
Batch No. BA Batch Size 150000 Tablets
Mfg. Date Exp. Date
Page No: 14 of 13
PREPARED BY CHECKED BY APPROVED BY
SIGNATURE
NAME Aarati Karki Sunil Panjiyar Nishant Kumar Gupta
DESIGNATION Q.A. OFFICER PRODUCTION MANAGER Q.A. MANAGER
DATE 15/01/2021 15/01/2021 15/01/2021