BATCH MANUFACTURING RECORD

PRODUCT NAME AROMET ER-1000 BPR No. AP/AD014

PRODUCT CODE AD014 REV. No. 001
Batch No. DN Batch Size 100000 Tablets
Mfg. Date Jan-21 Exp. Date Dec-22

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 18/01/2021 18/01/2021 18/01/2021

SECTION : TABLET
INFORMATIONS
Product Name AROMET ER-1000
Generic Name Metformin Extended Release Tablets USP
Product Code AD014
Each Uncoated Extended Release Tablet Contains:
Composition Metformin Hcl USP 1000 mg

Batch no.: DN Batch Size: 100000 Tablets

Mfg. Date: Jan-21 Exp. Date Dec-22

Issue Reference No:

Issued By (QA Received By (Production)

Group KHA
MRP Rs. 60/- Per 10 Tablets
Pack Size 10*10
Manufacturing License No. 1760603081858
BMR Record No. AP/AD014
Shelf Life 24 months
Standard Batch Size 100000 Tablets
Arrow Pharmaceutical Pvt. Ltd.,
Manufacturing by & Location
Changunarayan-08, Bhaktapur, Nepal
BMR Effective Date 18/01/2021
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

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 BATCH MANUFACTURING RECORD
PRODUCT NAME AROMET ER-1000 BPR No. AP/AD014
PRODUCT CODE AD014 REV. No. 001
Batch No. DN Batch Size 100000 Tablets
Mfg. Date Jan-21 Exp. Date Dec-22

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 18/01/2021 18/01/2021 18/01/2021

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 22° ± 2°C and Relative huidity 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 dispensing.

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 BATCH MANUFACTURING RECORD
PRODUCT NAME AROMET ER-1000 BPR No. AP/AD014
PRODUCT CODE AD014 REV. No. 001
Batch No. DN Batch Size 100000 Tablets
Mfg. Date Jan-21 Exp. Date Dec-22

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 18/01/2021 18/01/2021 18/01/2021

2 LINE CLEARANCE CHECKLIST FOR DISPENSING AREA

S.No. ACTIVITY (Yes/No/NA) Remarks SIGN

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.

Containers and other equipments used for weighing and transferring the material are
5
clean and dry.

…. Mm of
Check and ensure that LAF of the dispensing booth is on Limit :
water
10 to 15 mm of water column. Check the
6 column ..
temperature and RH of the dispensing area is ON
…....°C ........
Limit: 22° ± 2°C and 45 ± 5% respectively.
RH

Materials are brought in original pack of dispensing and verified for FIFO system and
7
Q.C approval labels.

8 Check whether the RM requisition sheet is ready and signed by authorized person

Production Pharmacist Q.A. Pharmacist

RAW MATERIAL WEIGHT CHECKING

a) After Line Clearance of Disppensing 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

polybag.

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 BATCH MANUFACTURING RECORD
PRODUCT NAME AROMET ER-1000 BPR No. AP/AD014
PRODUCT CODE AD014 REV. No. 001
Batch No. DN Batch Size 100000 Tablets
Mfg. Date Jan-21 Exp. Date Dec-22

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 18/01/2021 18/01/2021 18/01/2021

RAW MATERIALS WEIGHT CHECKING (Production Copy)

Qty / Batch Lot (Kg)

Label Qty/
Specifi Qty
S.No RAW MATERIAL Claim Tab A.R. No.
cation Disp
(mg) (mg)
100000 Unit A B C

1 Metformin Hcl USP 1000 1000 100 Kg 50 50

2 HPMC K-100 IP 180 18 Kg 9 9

3 Sodium CMC DVP IP 30 3 Kg 1.5 1.5

4 PVP K30 IP 30 3 Kg 1.5 1.5

5 Stearic Acid IP 80 8 Kg 4 4

6 IPA IP 400 40 Kg 20 20

Lubrication

7 Magnesium Stearate IP 10 1 Kg

Total Weight 1330 133 Kg

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

Checked By (production)…........................................... Checked By (QA) …...................................................

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 BATCH MANUFACTURING RECORD
PRODUCT NAME AROMET ER-1000 BPR No. AP/AD014
PRODUCT CODE AD014 REV. No. 001
Batch No. DN Batch Size 100000 Tablets
Mfg. Date Jan-21 Exp. Date Dec-22

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 18/01/2021 18/01/2021 18/01/2021

RAW MATERIALS WEIGHT CHECKING (Store Copy)

Qty / Batch Lot (Kg)

Label Qty/
Specifi Qty
S.No RAW MATERIAL Claim Tab A.R. No.
cation Disp
(mg) (mg)
100000 Unit A B C

1 Metformin Hcl USP 1000 1000 100 Kg 50 50

2 HPMC K-100 IP 180 18 Kg 9 9

3 Sodium CMC DVP IP 30 3 Kg 1.5 1.5

4 PVP K30 IP 30 3 Kg 1.5 1.5

5 Stearic Acid IP 80 8 Kg 4 4

6 IPA IP 400 40 Kg 20 20

Lubrication

7 Magnesium Stearate IP 10 1 Kg

Total Weight 1330 133 Kg

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

Checked By (production)…........................................... Checked By (QA) …...................................................

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 BATCH MANUFACTURING RECORD
PRODUCT NAME AROMET ER-1000 BPR No. AP/AD014
PRODUCT CODE AD014 REV. No. 001
Batch No. DN Batch Size 100000 Tablets
Mfg. Date Jan-21 Exp. Date Dec-22

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 18/01/2021 18/01/2021 18/01/2021
3 LIST OF EQUIPMENTS AND THEIR CLEANING RECORD:
Equipment Previous Product Cleaning SOP Date of Cleaned Checked By
S.No. Name Of Equipment
Code No. & Batch No. No. Cleaning By Prodn. Q.A.
1 Sifter AP/G/M005 AP/WI/QA/T-303
2 RMG AP/G/M007 AP/WI/QA/T-307
3 Multimill AP/G/M009 AP/WI/QA/T-305
4 Co-Mill AP/G/M008 AP/WI/QA/T-315
5 Fludized Bed Dryer AP/G/M006 AP/WI/QA/T-317
6 Octagonal Blender AP/G/M012 AP/WI/QA/T-333
Rotary Tablet
7 AP/G/M014 AP/WI/QA/T-309
Compression M/C
8 Coating Machine AP/G/M026 AP/WI/QA/T-325
4 LINE CLEARANCE CHECKLIST FOR GRANULATION AREA
S.No. Activity (Yes/No/NA) Remarks Signature
1 Ensure cleanliness of manufacturing area and equipments.
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 from
3
granulation.
4 All types of wastages are removed from granulation 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.
GRANUATION AREA IS CLEANED FOR PROCESSING THE ABOVE PRODUCT/ BATCH

Production Pharmacist Q.A. Pharmacist

5 VERIFICATION OF RAW MATERIALS:
Check Store's tag on each raw material with respect to Product Name, Batch Number, A.R. No. & Quantity against Operational
5.1
Raw material list, Mfg. Date & Exp. Date of Raw Materials.
5.2 Initial the tab and BMR with date on verification
5.3 Attach all Raw Material tags to BMR.

Production Pharmacist Date:…......................................

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 BATCH MANUFACTURING RECORD
PRODUCT NAME AROMET ER-1000 BPR No. AP/AD014
PRODUCT CODE AD014 REV. No. 001
Batch No. DN Batch Size 100000 Tablets
Mfg. Date Jan-21 Exp. Date Dec-22

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 18/01/2021 18/01/2021 18/01/2021
Counter
6 Manufacturing Process Checked By :
Checked By:
S.N. Date: RH….... Temp…...... °C DP….... Pa
6.1 Sifting
Pass the following ingredients through the specified mesh in sifter and collect on
double polybag respectively.
Sieve Quantity Dispensed (Kg)
Ingredients Specifie Sieve
d Used Lot A Lot B
Metformin Hcl # 60 50 50
HPMC K-100 # 60 9 9
Sodium CMC DVP # 60 1.5 1.5
Date: Lot A From:….......... To:…............ Total time:…..........
Date: Lot B From:….......... To:…............ Total time:…..........
Operator:…..........................................
6.2 Mixing
Transfer all the shifted materials in Step 6.2 to RMG and mix so as to get
uniform mixture.
Date: Lot A From:….......... To:…............ Total time:…..........
Date: Lot B From:….......... To:…............ Total time:…..........
6.3 Binder Solution Preparation
a Dissolve PVP K 30 in IPA.
b Melt Stearic acid at 50 ° C and mix with above PVP K30 solution.
Qty Dispensed
Ingredients
Lot A Lot B
PVP K30 1.50 1.50
Stearic Acid 4.00 4.00
IPA 20.00 20.00
6.4 Wet granulation.
Transfer the previously prepared Binder solution of step 6.3 to the RMG
with continuous mixing so as to get suitable granules.
Impeller Chopper Impeller Run Time Chopper Run Time Additional
Date Lot
Speed Speed Start Stop Total Start Stop Total water used

Total IPA used: Lot A Lot B

Operator:

Counter
Manufacturing Process Checked By :
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 BATCH MANUFACTURING RECORD
PRODUCT NAME AROMET ER-1000 BPR No. AP/AD014
PRODUCT CODE AD014 REV. No. 001
Batch No. DN Batch Size 100000 Tablets
Mfg. Date Jan-21 Exp. Date Dec-22

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 18/01/2021 18/01/2021 18/01/2021
Manufacturing Process Checked By :
Checked By:
6.5 Wet Passing
Pass the wet dough mass of step no. 6.4 through # 10 sieve or through Comill
fitted with # 8 Sieve to get granules.
Date: Lot A From:….......... To:…............ Total time:…..........
Date: Lot B From:….......... To:…............ Total time:…..........
6.6 Semi Drying
Transfer the obtained granules in a FBD and dry the granules at 50 - 60° C for 30 - 40
minutes (with racking after 10 minutes).
Date Lot Start Time Stop Time Total Time Operator
A
B
C
D
6.7 Semi Dry Sieving
Pass the Semi dried granules through # 20 Sieve.
Date Lot Start Time Stop Time Total Time Operator
A
B
C
D
6.8 Final Drying
Dry the semi dried shifted granules in FBD at 60° C till moisture content fall
to 2 - 3%.
Date Lot Start Time Stop Time Total Time Moisture(%) operator
A
B
C
D
6.9 Final Sieving
Pass the dried granules through # 20 Sieve.
Date: Lot A From:….......... To:…............ Total time:…..........
Date: Lot B From:….......... To:…............ Total time:…..........
Date: RH….... Temp…...... °C DP….... Pa
7.0 Lubrication
Equipment Name : Octagonal Blender
Equipment No. : AP/G/M012
Check Line Clearance of Lubrication area.
Previous Product : ….............................
Batch No.: …......................................... Cleaned By: …......................................

Production Pharmacist Q.A. Pharmacist

7.1 Pass the following through the specified mesh in sifter and collect on double polybag.

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 BATCH MANUFACTURING RECORD
PRODUCT NAME AROMET ER-1000 BPR No. AP/AD014
PRODUCT CODE AD014 REV. No. 001
Batch No. DN Batch Size 100000 Tablets
Mfg. Date Jan-21 Exp. Date Dec-22

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 18/01/2021 18/01/2021 18/01/2021
Sieve
Ingredients Sieve Used Quantity Dispensed
Specified
Magnesium Stearate # 60 1.000 kg
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 of step 6, recovered granules from step 7.2 and lubricants
from step 7.1 in octagonal belnder for 20 minutes.
From: ….................... To:…....................... Total time:…..........................
Operator : ….......................
Weight of the Lubricated Granules
Container No. Gross Wt. Tare wt. Net Wt.

Total Wt.
Theoretical Weight : kg
Practical Weight : kg % 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 report of granules for compression to BMR)

Date: RH….... Temp…...... °C DP….... Pa

9 of 14
 BATCH MANUFACTURING RECORD
PRODUCT NAME AROMET ER-1000 BPR No. AP/AD014
PRODUCT CODE AD014 REV. No. 001
Batch No. DN Batch Size 100000 Tablets
Mfg. Date Jan-21 Exp. Date Dec-22

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 18/01/2021 18/01/2021 18/01/2021
8 COMPRESSION
Equipment Name : 27 Station rotary compression M/C
Equipment Code : AP/G/M014
8.1 Setting of Compression Machine
Set Rotary Tablet Compression Macine with 22.5 mm Dies 22.5 mm Oblong punches.
S.No. Change Parts Code No.
1 Upper Punch P/U12
2 Lower Punch P/L12
3 Dies P/D12

8.2 LINE CLEARANCE OF COMPRESSION AREA

Previous Product : …...................................... Room : …...........................................
Batch Number : ….......................................... Date : ….............................................
S.No. Activity Put (Yes/No/NA) Remarks Signature
1 Containers of Tablets of previous product removed
2 Previous product / Batch No. / Status label removed.
3 Compression Machine and area is properly cleaned and dried.
4 All equipment / machinery are in perfect working order
5 All types of wastages are removed from compression area.
6 AHU is in proper working order.
7 All containers for use are properly cleaned.
COMPRESSION AREA IS CLEARED FOR PROCESSING OF THE ABOVE PRODUCT/ BATCH

Production Pharmacist Q.A. Pharmacist

8.3 DURING COMPRESSION CARRYOUT IN-PROCESS CHECK AS FOLLOW:
SPECIFICATION TIME
S.No PARAMETERS
MINIMUM STANDARD MAXIMUM INTERVAL
1 Weight of 20 Tablets 25.8 gm 26.60 gm 27.4 gm Every 15 Minutes
2 Weight Variation 1290 mg 1330.000 mg 1370 mg Hourly
3 Hardness - NLT 2 kg/cm² - Hourly
4 Friability - NMT 1 % - Hourly
5 Thickness 6.200 mm 6.400 mm 6.600 mm Hourly
6 Disintegration Time - NMT 10 minutes - Hourly

8.4 Progressive Report of Compression:

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 BATCH MANUFACTURING RECORD
PRODUCT NAME AROMET ER-1000 BPR No. AP/AD014
PRODUCT CODE AD014 REV. No. 001
Batch No. DN Batch Size 100000 Tablets
Mfg. Date Jan-21 Exp. Date Dec-22

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 18/01/2021 18/01/2021 18/01/2021
Weight of Hardness Thickness Disintegration Friability Carried Checked
Date Time Hopper side
20 Tablets ( Kp.) (mm) Time (min) (%) out By By

8.5 Weight Control Chart

Time
Target Wt.

8.6 Weight Variation Limit Lower Control Limit Middle Control Limit Upper Control Limit
8.6.1 Date & Time : Hopper Side :
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 BATCH MANUFACTURING RECORD
PRODUCT NAME AROMET ER-1000 BPR No. AP/AD014
PRODUCT CODE AD014 REV. No. 001
Batch No. DN Batch Size 100000 Tablets
Mfg. Date Jan-21 Exp. Date Dec-22

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 18/01/2021 18/01/2021 18/01/2021
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 …...............................
8.6.6 Date & Time : Hopper Side :
Weight of 20 Tablets :
Average weight of tablet :

Maximum Variation : …................ %

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

Compressed tablets are collected in double polythene lined PVC drums.

Weight of Compressed tablets:

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 BATCH MANUFACTURING RECORD
PRODUCT NAME AROMET ER-1000 BPR No. AP/AD014
PRODUCT CODE AD014 REV. No. 001
Batch No. DN Batch Size 100000 Tablets
Mfg. Date Jan-21 Exp. Date Dec-22

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 18/01/2021 18/01/2021 18/01/2021

Container No. Gross Wt. Tare wt. Net Wt.

Total Wt.

Theoretical Weight : kg

Practical Weight : kg % Yield : %

10 VISUAL INSPECTION

10.1 LINE CLEARANCE OF VISUAL INSPECTION OF TABLETS AREA

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

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

S.No. Activity Put (Yes/No/NA) Remarks Signature

1 Containers of Tablets of previous product removed

2 Previous product / Batch No. / Status label removed.

3 Inspection Machine and area is properly cleaned and dried.

4 All equipment / machinery are in perfect working order

5 All types of wastages are removed from Inspection area.

6 AHU is in proper working order.

7 All containers for use are properly cleaned.

VISUAL INSPECTION AREA IS CLEARED FOR PROCESSING OF THE ABOVE PRODUCT/ BATCH

Production Pharmacist Q.A. Pharmacist

Counter
Manufacturing Process Checked By :
Checked By
S.N. Date: RH….... Temp…...... °C DP….... Pa
10.2 Visual Inspection of Tablets:
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 BATCH MANUFACTURING RECORD
PRODUCT NAME AROMET ER-1000 BPR No. AP/AD014
PRODUCT CODE AD014 REV. No. 001
Batch No. DN Batch Size 100000 Tablets
Mfg. Date Jan-21 Exp. Date Dec-22

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 18/01/2021 18/01/2021 18/01/2021
Carry out visual inspection of each tablet to sort out any defects.
Quantity of defective tablets ….......................... Kg
Nature of defects : …..........................................
From:….......... To:…............ Total time:…..........
Done By :
Weight of coated tablets:
Container No. Gross Wt. Tare wt. Net Wt.

Total Wt.
Theoretical Weight : kg
Practical Weight : kg
% Yield :
Deviation (If any) :

Document attached with BMR

1 RM Requisition
2 RM dispensing Slip
3 Equipment cleaning record for line clearance
4 Equipment Cleaning Slip
5 Bulk Product analysis request memo
6 Bulk Product analysis report
7 Short fall memo (if any)
8 Short return memo (if any)
9 IPC Sheets
10 Weight control chart
11 Deviation document (if any)

Production Pharmacist Production Manager QA Officer QA Manager

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