BATCH MANUFACTURING RECORD

PRODUCT NAME LEVOKING-500 BPR No. AP/AGT004

PRODUCT CODE AGT004 REV. No. 00
Batch No. AN Batch Size 25000 Tablets
Mfg. Date Feb-21 Exp. Date Jan-23

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 11/2/2021 11/2/2021 11/2/2021

SECTION : TABLET

INFORMATIONS

Product Name LEVOKING-500

Generic Name Levofloxacin Tablets IP

Product Code AGT004

Each Film coated Tablet Contains:

Composition Levofloxacin Hemihydrate eqv to Levofloxacin IP 500 mg

Colour: Red Iron Oxide & Yellow Iron Oxide

Batch no.: AN Batch Size: 25000 Tablets

Mfg. Date: Feb-21 Exp. Date Jan-23

Issue Reference No:

Issued By (QA Received By (Production)

Group KHA

MRP Rs. 120/- Per 10 Tablets

Pack Size 10*10

Manufacturing License No. 1760603064528

BMR Record No. AP/AGT004

Shelf Life 24 months

Standard Batch Size 25000 Tablets

Manufacturing by & Location
BMR Effective Date
Precaution
Date of Commencement
Arrow Pharmaceutical Pvt. Ltd., Changunarayan-
08, Bhaktapur, Nepal
11/2/2021
Prevent cross contamination, unnecessary inhalation of the dust should be avoided. Use
protective clothing masks and gloves while working.

1 of 18
Date of Completion

BATCH MANUFACTURING RECORD

PRODUCT NAME LEVOKING-500 BPR No. AP/AGT004
PRODUCT CODE AGT004 REV. No. 00
Batch No. AN Batch Size 25000 Tablets
Mfg. Date Feb-21 Exp. Date Jan-23

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 11/2/2021 11/2/2021 11/2/2021

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.

2 of 18
 BATCH MANUFACTURING RECORD
PRODUCT NAME LEVOKING-500 BPR No. AP/AGT004
PRODUCT CODE AGT004 REV. No. 00
Batch No. AN Batch Size 25000 Tablets
Mfg. Date Feb-21 Exp. Date Jan-23

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 11/2/2021 11/2/2021 11/2/2021

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
6 column ..
the 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
7
and 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.'

3 of 18
 BATCH MANUFACTURING RECORD
PRODUCT NAME LEVOKING-500 BPR No. AP/AGT004
PRODUCT CODE AGT004 REV. No. 00
Batch No. AN Batch Size 25000 Tablets
Mfg. Date Feb-21 Exp. Date Jan-23

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 11/2/2021 11/2/2021 11/2/2021
& '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.

RAW MATERIALS WEIGHT CHECKING (Production Copy)

Label Qty/Batch
Specific Qty/Tab Qty.
S.No RAW MATERIAL Claim A.R. No.
ation (mg) Dispensed
(mg) 25000 unit

Levofloxacin Hemihydrate eqv to

1 IP 500 508.400 12.71 kg
Levofloxacin

2 Sodium Starch glycolate IP 30.000 0.750 kg

3 MCCP 101* IP 44.600 1.115 kg

4 Ethly cellulose IP 10.000 0.250 kg

5 IPA IP 200.000 5.000 kg

Lubrication

6 Sodium Starch glycolate IP 10.000 0.250 kg

7 Purified Talc IP 10.000 0.250 kg

8 Magnesium Stearate IP 6.000 0.150 kg

9 MCCP 101 IP 11.000 0.275 kg

Total Weight 630.000 15.750

Coating

10 Instacoat Universal Brown (A05G04137) IH 25.200 0.630 kg

11 Isopropyl Alcohol IP 191.520 4.788 kg

4 of 18
 BATCH MANUFACTURING RECORD
PRODUCT NAME LEVOKING-500 BPR No. AP/AGT004
PRODUCT CODE AGT004 REV. No. 00
Batch No. AN Batch Size 25000 Tablets
Mfg. Date Feb-21 Exp. Date Jan-23

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 11/2/2021 11/2/2021 11/2/2021

12 Methylene Chloride IP 287.280 7.182 kg

Average Weight 655.200 16.380 kg

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

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

RAW MATERIALS WEIGHT CHECKING (Store Copy)

Label Qty/Batch
Specific Qty/Tab Qty.
S.No RAW MATERIAL Claim A.R. No.
ation (mg) Dispensed
(mg) 25000 unit

Levofloxacin Hemihydrate eqv to

1 IP 500 508.400 12.71 kg
Levofloxacin

2 Sodium Starch glycolate IP 30.000 0.750 kg

3 MCCP 101* IP 44.600 1.115 kg

4 Ethly cellulose IP 10.000 0.250 kg

5 IPA IP 200.000 5.000 kg

Lubrication

6 Sodium Starch glycolate IP 10.000 0.250 kg

7 Purified Talc IP 10.000 0.250 kg

8 Magnesium Stearate IP 6.000 0.150 kg

9 MCCP 101 IP 11.000 0.275 kg

Total Weight 630.000 15.750

Coating

10 Instacoat Universal Brown (A05G04137) IH 25.200 0.630 kg

5 of 18
 BATCH MANUFACTURING RECORD
PRODUCT NAME LEVOKING-500 BPR No. AP/AGT004
PRODUCT CODE AGT004 REV. No. 00
Batch No. AN Batch Size 25000 Tablets
Mfg. Date Feb-21 Exp. Date Jan-23

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 11/2/2021 11/2/2021 11/2/2021

11 Isopropyl Alcohol IP 191.520 4.788 kg

12 Methylene Chloride IP 287.280 7.182 kg

Average Weight 655.200 16.380 kg

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

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

CALCULATION:

AR No. AP/RM/19/095
Label Claim 500 mg ov 0 % Remaining Batch Size = 25000 - 1877.7016
Conversion Factor 1 % Qty : 0.943 Kg = 23122.2984 Tabs
Assay 99.56 %
Loss on Drying 0 % AR No. AP/RM/20/042
Batch Size 25000 Tabs Assay 100.72 %
Loss on Drying 2.45 %

LC X CF X 10000 LC X CF X 10000
+ ov + ov
Assay X 100 - LOD Assay X 100 - LOD

500 X 1 X 10000 500 X 1 X 10000

+ 0 % + 0 %
99.56 X 100 - 0 100.72 X 100 - 2.45

5000000 5000000
+ 0 % + 0 %
99.56 X 100 100.72 X 97.55

5000000 5000000
+ 0 % + 0 %
9956 9,825.24
502.209722780233 + 0 % 508.89 + 0 %

502.209722780233 mg/tab 508.8936 mg/tab

6 of 18
 BATCH MANUFACTURING RECORD
PRODUCT NAME LEVOKING-500 BPR No. AP/AGT004
PRODUCT CODE AGT004 REV. No. 00
Batch No. AN Batch Size 25000 Tablets
Mfg. Date Feb-21 Exp. Date Jan-23

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 11/2/2021 11/2/2021 11/2/2021

Therfore for 0.943 Kg Thus for 23122.2984 tabs

= 0.943 X 1000 X 1000 = 23122.2984 X 508.89
502.209722780233 1000 X 1000

= 943000 = 11,766,790.33
= 11.77 kg
502.209722780233 1000000

= 1,877.70 tabs Thus, total 0.943 kg + 11.77 kg 12.71 Kg

=

3 LIST OF EQUIPMENTS AND THEIR CLEANING RECORD:

Previous Product Checked By
Name Of Equipment Date of Cleane
S.No. & Cleaning SOP No.
Equipment Code No. Batch No. Cleaning d 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 of 18
 BATCH MANUFACTURING RECORD
PRODUCT NAME LEVOKING-500 BPR No. AP/AGT004
PRODUCT CODE AGT004 REV. No. 00
Batch No. AN Batch Size 25000 Tablets
Mfg. Date Feb-21 Exp. Date Jan-23

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 11/2/2021 11/2/2021 11/2/2021
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
5.1
Operational 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:…......................................

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 Quantity
Ingredients Specified Sieve Used
Specified Dispensed
Levofloxacin Hemihydrate eqv to
# 60 12.710 kg kg
Levofloxacin
Sodium Starch glycolate # 60 0.750 kg kg
MCCP 101* # 60 1.115 kg kg
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.
From: ….................... To:…....................... Total time:…..........................
6.3 Binder Solution Preparation
a Dissolve the Ethyl cellulose in IPA.
8 of 18
 BATCH MANUFACTURING RECORD
PRODUCT NAME LEVOKING-500 BPR No. AP/AGT004
PRODUCT CODE AGT004 REV. No. 00
Batch No. AN Batch Size 25000 Tablets
Mfg. Date Feb-21 Exp. Date Jan-23

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 11/2/2021 11/2/2021 11/2/2021
b Make sure ethylcellulose is completely dissolved.
Ingredients Qty Specified Qty Dispensed
Ethly cellulose 0.250 kg kg
IPA 5.000 kg kg
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 Speed : Impeller Run Time :
Chopper Speed : Chopper Run Time :
Additional IPA Used : Total IPA Used :
From: ….................... To:…....................... Total time:…..........................
Operator:…..........................................

Counter
Manufacturing Process Checked By :
Checked By:
6.5 Wet Passing
Pass the wet dough mass of step no. 6.4 through # 12 sieve or through Comill
fitted with # 8 Sieve to get granules.
From: ….................... To:…....................... Total time:…..........................
6.6 Semi Drying
Transfer the obtained granules in a FBD tray and dry the granules at 60° C for 30-40
minutes (with racking after 10 minutes).
From: ….................... To:…....................... Total time:…..........................
6.7 Semi Dry Sieving
Pass the Semi dried granules through # 16 Sieve.
From: ….................... To:…....................... Total time:…..........................
6.8 Final Drying
Dry the semi dried shifted granules in FBD at 100° C till moisture content fall
to 2 - 3%.
From: ….................... To:…....................... Total time:…..........................
9 of 18
 BATCH MANUFACTURING RECORD
PRODUCT NAME LEVOKING-500 BPR No. AP/AGT004
PRODUCT CODE AGT004 REV. No. 00
Batch No. AN Batch Size 25000 Tablets
Mfg. Date Feb-21 Exp. Date Jan-23

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 11/2/2021 11/2/2021 11/2/2021
Moisture Content of Granules %
6.9 Final Sieving
Pass the dried granules through # 16 Sieve.
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.
Sieve Quantity
Ingredients Sieve Used Qty Used
Specified Specified
Sodium Starch glycolate # 60 0.250 gm gm
Purified Talc # 60 0.250 gm gm
Magnesium Stearate # 60 0.150 gm gm
MCCP 101 # 60 0.275 gm gm

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
10 of 18
 BATCH MANUFACTURING RECORD
PRODUCT NAME LEVOKING-500 BPR No. AP/AGT004
PRODUCT CODE AGT004 REV. No. 00
Batch No. AN Batch Size 25000 Tablets
Mfg. Date Feb-21 Exp. Date Jan-23

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 11/2/2021 11/2/2021 11/2/2021
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 : 15.750 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
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 12 mm Dies 12 mm round biconcave punches.
S.No. Change Parts Code No.

11 of 18
 BATCH MANUFACTURING RECORD
PRODUCT NAME LEVOKING-500 BPR No. AP/AGT004
PRODUCT CODE AGT004 REV. No. 00
Batch No. AN Batch Size 25000 Tablets
Mfg. Date Feb-21 Exp. Date Jan-23

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 11/2/2021 11/2/2021 11/2/2021
1 Upper Punch RUP 010
2 Lower Punch RLP 010
3 Dies RDI 010

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 12.222 gm 12.600 gm 12.978 gm Every 15 Minutes
2 Weight Variation 611 mg 630.000 mg 649 mg Hourly
3 Hardness - NLT 3 kg/cm² - Hourly
4 Friability - NMT 1 % - Hourly
5 Thickness 5.600 mm 5.800 mm 6.000 mm Hourly
6 Disintegration Time - NMT 10 minutes - Hourly
Time
Date Carried Out By Checked By Remarks
From To

8.4 Progressive Report of Compression:

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

12 of 18
 BATCH MANUFACTURING RECORD
PRODUCT NAME LEVOKING-500 BPR No. AP/AGT004
PRODUCT CODE AGT004 REV. No. 00
Batch No. AN Batch Size 25000 Tablets
Mfg. Date Feb-21 Exp. Date Jan-23

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 11/2/2021 11/2/2021 11/2/2021

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 :
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 :

13 of 18
 BATCH MANUFACTURING RECORD
PRODUCT NAME LEVOKING-500 BPR No. AP/AGT004
PRODUCT CODE AGT004 REV. No. 00
Batch No. AN Batch Size 25000 Tablets
Mfg. Date Feb-21 Exp. Date Jan-23

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 11/2/2021 11/2/2021 11/2/2021

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

Total Wt.
Theoretical Weight : kg
Practical Weight : kg % Yield : %
9 Coating
9.1 Line Clearance of Coating Area:
Check the line clearance of coating machine & coating area.
Date : …............................. Previous product ….........................................

14 of 18
 BATCH MANUFACTURING RECORD
PRODUCT NAME LEVOKING-500 BPR No. AP/AGT004
PRODUCT CODE AGT004 REV. No. 00
Batch No. AN Batch Size 25000 Tablets
Mfg. Date Feb-21 Exp. Date Jan-23

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 11/2/2021 11/2/2021 11/2/2021
Checked By : Production …............................... Verified By: IPQC/QA …................................
9.2 Coating Suspension Preparation
a Disperse Instacoat Universal Brown in Isopropyl alcohol with continuous stirring to get slurry.
b Transfer Methylene chloride solution to the above slurry with continuous stirring to get thick transparent mucilage.
c Stir the solution to about 45 minutes.
d After preparation of Coating suspension pass the solution through 200 mesh sieve.
Ingredients Qty Specified Qty Dispensed
Instacoat Universal Brown
0.630 kg kg
(A05G04137)
Isopropyl Alcohol 4.788 kg kg
Methylene Chloride 7.182 kg kg
Time : From …........................ To …........................................
Carried out By: ….................................... Checked By: …...............................
9.3 Coating
a De-dust the tablets properly and load in the coating pan.
b Pre-heat the tablets to 40 - 50 °C.
c Adjust the temperature to around 60 °C during spraying and drying.
d Continue the operation till proper film is formed. This is ascertained by visual inspection and checking the weight
gain of the coated tablet.

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

Weight of Tablets to be coated : …................. Kg
Time Solution Drying Carried
Date Checked By Remarks
From To Quantity Temperature Out By

9.4 Carry Out In-process checks as follows for each lot of coated tablets.
SPECIFICATION TIME
S.No PARAMETERS
MINIMUM STANDARD MAXIMUM INTERVAL
1 Weight of 20 Tablets 12.53 gm 12.915 gm 13.30 gm Every 15 Minutes
15 of 18
 BATCH MANUFACTURING RECORD
PRODUCT NAME LEVOKING-500 BPR No. AP/AGT004
PRODUCT CODE AGT004 REV. No. 00
Batch No. AN Batch Size 25000 Tablets
Mfg. Date Feb-21 Exp. Date Jan-23

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 11/2/2021 11/2/2021 11/2/2021
2 Weight Variation 626 mg 645.750 mg 665 mg Hourly
3 Thickness 5.700 mm 5.900 mm 6.100 mm Hourly
4 Disintegration Time - NMT 15 minutes - Hourly

9.5 INPROCESS RECORD OF COATED TABLETS

Weight of Disintegration Checked

Date Time Thickness (mm) Carried out By
20 Tablets Time (min) By

9.5.1 Date & Time …........................................................

Average Weight Of Compressed Tablet : Before Coating After Coating
Average Weight of Coated Tablet :
% Weight gain :
Avg.: Avg.:

Individual weight of coated tablets

Operator : …....................... Checked By : …...........................

Coated tablets are collected in double polythene lined PVC drums.

Weight of Coated tablets:
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 : ….............................................
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 BATCH MANUFACTURING RECORD
PRODUCT NAME LEVOKING-500 BPR No. AP/AGT004
PRODUCT CODE AGT004 REV. No. 00
Batch No. AN Batch Size 25000 Tablets
Mfg. Date Feb-21 Exp. Date Jan-23

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 11/2/2021 11/2/2021 11/2/2021
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

S.N. Date: RH….... Temp…...... °C DP….... Pa
10.2 Visual Inspection of Tablets:
Carry out visual inspection of each tablet to sort out any defects.
Quantity of defective tablets ….......................... Kg
Nature of defects : …..........................................
Weight of sorted tablets:
Container No. Gross Wt. Tare wt. Net Wt.

Total Wt.
Theoretical Weight : kg
Practical Weight : kg
% Yield :

Deviation (If any) :

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 BATCH MANUFACTURING RECORD
PRODUCT NAME LEVOKING-500 BPR No. AP/AGT004
PRODUCT CODE AGT004 REV. No. 00
Batch No. AN Batch Size 25000 Tablets
Mfg. Date Feb-21 Exp. Date Jan-23

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 11/2/2021 11/2/2021 11/2/2021

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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