BATCH MANUFACTURING RECORD

PRODUCT NAME CEFUROM-250 BMR No. AP/CF007

PRODUCT CODE CF007 REV. No. 00
Batch No. AG Batch Size 25000 Tablets
Mfg. Date Feb-21 Exp. Date Feb-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 2/16/2021 2/16/2021 2/16/2021

SECTION : TABLET
INFORMATIONS
Product Name CEFUROM-250
Generic Name Cefuroxime Axetil Tablets IP
Product Code CF007
Each Film Coated Tablet Contains:
Composition Cefuroxime Axetil IP eqv to Cefuroxime 250 mg
Colour: Red Iron Oxide & Titanium Dioxide
Batch no.: AG Batch Size: 25000 Tablets

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

Issue Reference No:

Issued By (QA Received By (Production)

Group KHA
MRP Rs. 400/- Per 10 Tablets
Pack Size 10*10
Manufacturing License No. 1760408025813
BMR Record No. AP/CF007
Shelf Life 24 months
Standard Batch Size 25000 Tablets
Arrow Pharmaceutical Pvt. Ltd.,
Manufacturing by & Location
Changunarayan-08, Bhaktapur, Nepal
BMR Effective Date 2/16/2021
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 CEFUROM-250 BPR No. AP/CF007
PRODUCT CODE CF007 REV. No. 00
Batch No. AG Batch Size 25000 Tablets
Mfg. Date Feb-21 Exp. Date Feb-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 2/16/2021 2/16/2021 2/16/2021

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 20
 BATCH MANUFACTURING RECORD
PRODUCT NAME CEFUROM-250 BPR No. AP/CF007
PRODUCT CODE CF007 REV. No. 00
Batch No. AG Batch Size 25000 Tablets
Mfg. Date Feb-21 Exp. Date Feb-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 2/16/2021 2/16/2021 2/16/2021
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.
5 Containers and other equipments used for weighing and transferring the material
are clean and dry.
6 Check and ensure that LAF of the dispensing booth is on …. Mm of
Limit: 10 to 15 mm of water column. water column
Check the temperature and RH of the dispensing area is on …....°C
Limit: 22° ± 2°C and 45 ± 5% respectively. ........RH
7 Materials are brought in original pack of dispensing and verified for FIFO system
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.'

& '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.

3 of 20
 BATCH MANUFACTURING RECORD
PRODUCT NAME CEFUROM-250 BPR No. AP/CF007
PRODUCT CODE CF007 REV. No. 00
Batch No. AG Batch Size 25000 Tablets
Mfg. Date Feb-21 Exp. Date Feb-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 2/16/2021 2/16/2021 2/16/2021

RAW MATERIALS WEIGHT CHECKING (Production Copy)

Specifi Label Qty/Tab Qty/Batch Qty.

S.No RAW MATERIAL A.R. No.
cation Claim (mg) 25000 unit Dispensed

1 Cefuroxime Axetil DC Grade IH 250 421.000 10.525 kg AP/RM/19/133

2 MCCP 101 IP 92.000 2.300 kg

3 Croscarmellose Sodium IP 10.000 0.250 kg

4 Aerosil IP 6.000 0.150 kg

Lubricantion

5 Magnesium Stearate IP 5.000 0.125 kg

IP
6 Citric Acid 15.000 0.375 kg
IP
7 10.000 0.250 kg
Sodium Bicarbonate
Total Weight 559.000 13.975 kg

Coating

8 Instacoat Universal Brown A05G04137 IH 11.180 0.280 kg

9 Instacoat Universal White IC-U-1308 IH 11.180 0.280 kg

10 Isopropyl Alcohol IP 85.0 2.12 kg

11 Methylene Chloride IP 127.5 3.19 kg

Average Weight 577.63 14.4

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

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

4 of 20
 BATCH MANUFACTURING RECORD
PRODUCT NAME CEFUROM-250 BPR No. AP/CF007
PRODUCT CODE CF007 REV. No. 00
Batch No. AG Batch Size 25000 Tablets
Mfg. Date Feb-21 Exp. Date Feb-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 2/16/2021 2/16/2021 2/16/2021

RAW MATERIALS WEIGHT CHECKING (Store Copy)

Specifi Label Qty/Tab Qty/Batch Qty.

S.No RAW MATERIAL A.R. No.
cation Claim (mg) 25000 unit Dispensed

1 Cefuroxime Axetil DC Grade IP 250 421.000 10.525 kg AP/RM/19/133

2 MCCP 101 IP 92.000 2.300 kg

3 Croscarmellose Sodium IP 10.000 0.250 kg

4 Aerosil IP 6.000 0.150 kg

Lubricantion

5 Magnesium Stearate IP 5.000 0.125 kg

6 Citric Acid IP 15.000 0.375 kg

7 Sodium Bicarbonate IP 10.000 0.250 kg

Total Weight 559.000 13.975 kg

Coating

8 Instacoat Universal Brown A05G04137 IH 11.180 0.280 kg

9 Instacoat Universal White IC-U-1308 IH 11.180 0.280 kg

10 Isopropyl Alcohol IP 84.968 2.124 kg

11 Methylene Chloride IP 127.452 3.186 kg

Average Weight 577.631 14.441

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

Dispensed By …............................................

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

5 of 20
 BATCH MANUFACTURING RECORD
PRODUCT NAME CEFUROM-250 BPR No. AP/CF007
PRODUCT CODE CF007 REV. No. 00
Batch No. AG Batch Size 25000 Tablets
Mfg. Date Feb-21 Exp. Date Feb-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 2/16/2021 2/16/2021 2/16/2021

CALCULATION:

AR No. AP/RM/19/133
Label Claim 250 mg ov 0 % Remaining Batch Size = 25000 - 0
Conversion Factor 1 % Qty : 0 Kg = 25000 Tabs
Assay 60.49 %
Loss on Drying 1.78 % AR No.
Batch Size 25000 Tabs Assay 97 %
Loss on Drying 0.02 %

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

250 X 1 X 10000 250 X 1 X 10000

+ 0 % + 0 %
60.49 X 100 - 1.78 97 X 100 - 0.02

2500000 2500000
+ 0 % + 0 %
60.49 X 98.22 97 X 99.98

2500000 2500000
+ 0 % + 0 %
5941.3278 9,698.06
420.781361365047 + 0 % 257.78 + 0 %

420.781361365047 mg/tab 257.78 mg/tab

421 mg/tab
Therfore for 0 Kg Thus for 25000 tabs
= 0 X 1000 X 1000 = 25000 X 257.78
420.781361365047 1000 X 1000

= 0 = 6,444,587.89
420.781361365047 1000000

= - tabs = 6.44 kg
Therefore total Cefuroxime Axetil DC Grade
required is 6.44 kg

6 of 20
 BATCH MANUFACTURING RECORD
PRODUCT NAME CEFUROM-250 BPR No. AP/CF007
PRODUCT CODE CF007 REV. No. 00
Batch No. AG Batch Size 25000 Tablets
Mfg. Date Feb-21 Exp. Date Feb-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 2/16/2021 2/16/2021 2/16/2021

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/CF/M003
3 Multimill AP/CF/M007
5 Fludized Bed Dryer AP/CF/M004
6 Octagonal Blender AP/CF/M005
Rotary Tablet
7 AP/CF/M009
Compression M/C
8 Coating Machine AP/CF/M013
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
3
removed from 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
6
for 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:
5.1 Check Store's tag on each raw material with respect to Product Name, Batch Number, A.R. No. & Quantity against
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:…......................................

7 of 20
 BATCH MANUFACTURING RECORD
PRODUCT NAME CEFUROM-250 BPR No. AP/CF007
PRODUCT CODE CF007 REV. No. 00
Batch No. AG Batch Size 25000 Tablets
Mfg. Date Feb-21 Exp. Date Feb-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 2/16/2021 2/16/2021 2/16/2021

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
Sieve Quantity Quantity
Ingredients
Specified Used Specified Dispensed
Cefuroxime Axetil DC Grade # 60 10.525 kg kg
MCCP 101 # 60 2.300 kg kg
Croscarmellose Sodium # 60 0.250 kg kg
Aerosil # 60 0.150 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:…..........................
7 Slugging
Equipment Name Compression machine
Equipment No. AP/CF/M005
7.1 Setting of Compression Machine
Set Rotary Tablet Compression Macine with 12mm Dies 12 mm concave punches.
S.N Change Parts Code No. Specification No.
I Upper Punch P/U08
II Lower Punch P/L08
III Dies P/D08

8 of 20
 BATCH MANUFACTURING RECORD
PRODUCT NAME CEFUROM-250 BPR No. AP/CF007
PRODUCT CODE CF007 REV. No. 00
Batch No. AG Batch Size 25000 Tablets
Mfg. Date Feb-21 Exp. Date Feb-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 2/16/2021 2/16/2021 2/16/2021
7.2 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

7.3 Slugging Compression
Compress the mixed material of step 2 to form slug.
Pass the slug through 24 mesh sieve to get granules.
From: To: Total time:
Operator:
Date: RH….... Temp…...... °C DP….... Pa
7.0 Lubrication
Equipment Name : Octagonal Blender
Equipment No. : AP/CF/M005
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.

Ingredients Sieve Sieve Used Quantity Qty Used

Specified Specified
Magnesium Stearate # 60 0.125 kg kg

Citric Acid # 60 0.375 kg kg

Sodium Bicarbonate # 60 0.250 kg kg

9 of 20
 BATCH MANUFACTURING RECORD
PRODUCT NAME CEFUROM-250 BPR No. AP/CF007
PRODUCT CODE CF007 REV. No. 00
Batch No. AG Batch Size 25000 Tablets
Mfg. Date Feb-21 Exp. Date Feb-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 2/16/2021 2/16/2021 2/16/2021
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 : %

10 of 20
 BATCH MANUFACTURING RECORD
PRODUCT NAME CEFUROM-250 BPR No. AP/CF007
PRODUCT CODE CF007 REV. No. 00
Batch No. AG Batch Size 25000 Tablets
Mfg. Date Feb-21 Exp. Date Feb-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 2/16/2021 2/16/2021 2/16/2021

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/CF/M009
8.1 Setting of Compression Machine
Set Rotary Tablet Compression Macine with 12mm Dies 12 mm concave punches.
S.No. Change Parts Code No.
1 Upper Punch P/U08
2 Lower Punch P/L08
3 Dies P/D08

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

11 of 20
 BATCH MANUFACTURING RECORD
PRODUCT NAME CEFUROM-250 BPR No. AP/CF007
PRODUCT CODE CF007 REV. No. 00
Batch No. AG Batch Size 25000 Tablets
Mfg. Date Feb-21 Exp. Date Feb-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 2/16/2021 2/16/2021 2/16/2021
8.3 DURING COMPRESSION CARRYOUT IN-PROCESS CHECK AS FOLLOW:
SPECIFICATION TIME
S.No PARAMETERS
MINIMUM STANDARD MAXIMUM INTERVAL
1 Weight of 20 Tablets 0.194 gm 0.200 gm 0.206 gm Every 15 Minutes
2 Weight Variation 9.7 mg 10.000 mg 10.3 mg Hourly
3 Hardness - NLT 5 kg/cm² - Hourly
4 Friability - NMT 1 % - Hourly
5 Thickness 5.300 mm 5.500 mm 5.700 mm Hourly
6 Disintegration Time - NMT 5 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

8.5 Weight Control Chart

Time
Target Wt.

12 of 20
 BATCH MANUFACTURING RECORD
PRODUCT NAME CEFUROM-250 BPR No. AP/CF007
PRODUCT CODE CF007 REV. No. 00
Batch No. AG Batch Size 25000 Tablets
Mfg. Date Feb-21 Exp. Date Feb-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 2/16/2021 2/16/2021 2/16/2021
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 :

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 …...............................

13 of 20
 BATCH MANUFACTURING RECORD
PRODUCT NAME CEFUROM-250 BPR No. AP/CF007
PRODUCT CODE CF007 REV. No. 00
Batch No. AG Batch Size 25000 Tablets
Mfg. Date Feb-21 Exp. Date Feb-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 2/16/2021 2/16/2021 2/16/2021

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 ….........................................

Checked By : Production …............................... Verified By: IPQC/QA …................................

9.2 Coating Suspension Preparation

a Disperse Instacoat Universal Pink 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 A05G04137 0.280
Instacoat Universal White IC-U-1308 0.280
Isopropyl Alcohol 2.124
Methylene Chloride 3.186

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

14 of 20
 BATCH MANUFACTURING RECORD
PRODUCT NAME CEFUROM-250 BPR No. AP/CF007
PRODUCT CODE CF007 REV. No. 00
Batch No. AG Batch Size 25000 Tablets
Mfg. Date Feb-21 Exp. Date Feb-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 2/16/2021 2/16/2021 2/16/2021
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 11.21 gm 11.553 gm 11.90 gm Every 15 Minutes
2 Weight Variation 560 mg 577.631 mg 595 mg Hourly
3 Thickness 5.400 mm 5.600 mm 5.800 mm Hourly
4 Disintegration Time - NMT 10 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 : …...........................

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

15 of 20
 BATCH MANUFACTURING RECORD
PRODUCT NAME CEFUROM-250 BPR No. AP/CF007
PRODUCT CODE CF007 REV. No. 00
Batch No. AG Batch Size 25000 Tablets
Mfg. Date Feb-21 Exp. Date Feb-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 2/16/2021 2/16/2021 2/16/2021

Counter
Manufacturing Process Checked By :
Checked By:
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 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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 BATCH MANUFACTURING RECORD
PRODUCT NAME CEFUROM-250 BPR No. AP/CF007
PRODUCT CODE CF007 REV. No. 00
Batch No. AG Batch Size 25000 Tablets
Mfg. Date Feb-21 Exp. Date Feb-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 2/16/2021 2/16/2021 2/16/2021

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 #REF!

#REF!

212.42

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