MICRO LABS LIMITED, VERNA-GOA (ML06) Page 5 of 84

BATCH MANUFACTURING RECORD Batch Size: 2,240,000 Tablets

Product Metformin 500 mg Tablets EU BMR No.: BMR1:MOAHG:UK01/R6
Generic Name Metformin 500 mg Tablets Batch No.: MOAG

2.0 BATCH MANUFACTURING FORMULA:

Label Quantity for the Batch in Kg
Name of Over- Input Qty.
Sr. Item Claim
Pharmaceutical Grade ages per tablet Theoretical Actual
No. code per tablet
Ingredient % in mg Quantity Quantity
in mg
INTRA-GRANULAR MATERIALS
RADM110
1 Metformin Hydrochloride Ph.Eur. 500.0 Nil 500.0 1120.000 1120.000
RADM162
Povidone K-30 (Plasdone K- REND308 -
2 Ph.Eur. Nil 13.8 30.912 30.912
29/32)
GRANULATING FLUID
Polyvinyl Pyrrolidone -
3 Ph.Eur. REND235 Nil 13.3 29.792 29.792
(Plasdone K-90)
4 Purified Water # Ph.Eur. REND146 - Nil -- 91.600 91.600
EXTRA GRANULAR MATERIAL
5 Silica Colloidal Anhydrous Ph. Eur. REND087 - Nil 1.2 2.688 2.688
LUBRICATION MATERIALS

6 Magnesium Stearate Ph.Eur. REND085 - Nil 2.7 6.048 6.048

Theoretical Weight of Core tablet 531.0 1189.440 1189.440

COATING MATERIAL
7 Opadry Y1-7000H White IH REND219 - 25% 16.0 * 44.800 ** 44.800 **
8 Purified Water # Ph. Eur. REND146 - 25% -- 361.200** 361.200**
Theoretical Weight of Coated tablet 547.0 1225.280 1225.280
Note: # Processing solvent not present in final product except traces.
* Solids remaining on tablet (Suspension of 11% solids)
** 25% Extra coating material used to compensate process loss during coating process

2.1 API Source:

Name of the API Source 1) Wanbury Limited 2) USV Limited

Note: For a single batch API from 2 different vendors is not to be dispensed.

BMR:TMT:DS:01, Page 5 of 12
Prepared by: Approved by:

Site Quality Assurance Site Quality Assurance Head

Date
L:004:BMSRN/C
 MICRO LABS LIMITED, VERNA-GOA (ML06) Page 8 of 84
BATCH MANUFACTURING RECORD Batch Size: 2,240,000 Tablets
Product Metformin 500 mg Tablets EU BMR No.: BMR1:MOAHG:UK01/R6
Generic Name Metformin 500 mg Tablets Batch No.: MOAG

BMR COPY / STORE COPY

4.0 RAW MATERIALS WEIGHING RECORD: (FOR GRANULATION AND LUBRICATION)

4.1 EXCIPIENTS WEIGHING RECORD:

Quantity weighed Packed in Verification
Sr. Quantity Weighed Ckd. by /
Item Theoret- Retest Cont./Cage No. at the
No. Ingredients Grade LOT UOM to be A.R. No. Balance no. by/ date date
Code ical Qty. Date Gross Tare Net staging area
Weighed Wt. Wt. Wt. Container Cage (Store) (Prod.)
by Prod
INTRA-GRANULAR MATERIAL

I kg 7.728 7.728
Total

II kg 7.728 7.728
Povidone K-30
Ph. Total
(Plasdone K-
1. 29/32)
Eur. REND308

III kg 7.728 7.728

Total

IV kg 7.728 7.728
Total
GRANULATING FLUID

I kg 7.448 7.448
Polyvinyl
Pyrrolidone Ph. Total
1 (Plasdone Eur.
REND235
K-90)
II kg 7.448 7.448
Total
Note: Photocopy of Excipients weighing record shall be retained as the Store copy.

4.2 ALLOTING DATE OF COMMENCEMENT OF THE BATCH: Responsibility: Production

Write the date of dispensing of first material as date of commencement in the Batch Record Cover Sheet. Production Sign and Date:………………

BMR:TMT:DS:01, Page 8 of 12
Prepared by: Approved by:

Site Quality Assurance Site Quality Assurance Head

Date
L:004:BMSRN/C
 MICRO LABS LIMITED, VERNA-GOA (ML06) Page 9 of 84
BATCH MANUFACTURING RECORD Batch Size: 2,240,000 Tablets
Product Metformin 500 mg Tablets EU BMR No.: BMR1:MOAHG:UK01/R6
Generic Name Metformin 500 mg Tablets Batch No.: MOAG

BMR COPY / STORE COPY

4.0 RAW MATERIAL WEIGHING RECORD: (FOR GRANULATION AND LUBRICATION) (Continued…)
4.3 EXCIPIENT WEIGHING RECORD:
Quantity weighed Packed in Verification
Sr. Quantity Weighed Ckd. by /
Item Theoret- A.R. Retest Balance Cont./Cage No. by/ date at the
No. Ingredients Grade LOT UOM to be Gross Tare Net date
Code ical Qty. No. Date no. staging area
Weighed Wt. Wt. Wt. Container Cage (Store) (Prod.)
by Prod
GRANULATING FLUID MATERIAL

III kg 7.448 7.448

Polyvinyl
Pyrrolidone Ph. Total
1 REND235
(Plasdone K- Eur.
90)
IV kg 7.448 7.448
Total
EXTRA -GRANULAR MATERIAL

I kg 0.672 0.672
Total

II kg 0.672 0.672
Silica Colloidal Ph. Total
1. Anhydrous Eur. REND087

III kg 0.672 0.672

Total

IV kg 0.672 0.672
Total
LUBRICATION MATERIAL

Magnesium Ph.
1 REND 085 NA kg 6.048 6.048
Stearate Eur.
Total
Note: Photocopy of Excipients weighing record shall be retained as the Store copy.

BMR:TMT:DS:01, Page 9 of 12
Prepared by: Approved by:

Site Quality Assurance Site Quality Assurance Head

Date
L:004:BMSRN/C
 MICRO LABS LIMITED, VERNA-GOA (ML06) Page 10 of 84
BATCH MANUFACTURING RECORD Batch Size: 2,240,000 Tablets
Product Metformin 500 mg Tablets EU BMR No.: BMR1:MOAHG:UK01/R6
Generic Name Metformin 500 mg Tablets Batch No.: MOAG

BMR COPY / STORE COPY

4.0 RAW MATERIAL WEIGHING RECORD: (FOR GRANULATION AND LUBRICATION) (Continued…)
4.4 API WEIGHING RECORD:
Quantity weighed Packed in Cont./ Verifica-
Sr. Quantity Cage No. Weighed Ckd. by / Ckd. by / tion at the
Item Theoret- Retest
No. Ingredients Grade LOT UOM to be A.R. No. Gross Tare Net Balance no. by/ date date date staging
Code ical Qty. Date
Weighed Wt. Wt. Wt. Container Cage (Store) (Prod.) (IPQA) area by
Prod
API

I kg
280.000 280.000

RADM162/ Total
Metformin Ph.
1. RADM110
Hydrochloride Eur.

II 280.000 280.000
kg

Total
Note : Photocopy of API weighing record shall be retained as the Store copy.

BMR:TMT:DS:01, Page 10 of 12
Prepared by: Approved by:

Site Quality Assurance Site Quality Assurance Head

Date
L:004:BMSRN/C
 MICRO LABS LIMITED, VERNA-GOA (ML06) Page 11 of 84
BATCH MANUFACTURING RECORD Batch Size: 2,240,000 Tablets
Product Metformin 500 mg Tablets EU BMR No.: BMR1:MOAHG:UK01/R6
Generic Name Metformin 500 mg Tablets Batch No.: MOAG

BMR COPY / STORE COPY

4.0 RAW MATERIAL WEIGHING RECORD: (FOR GRANULATION AND LUBRICATION) (Continued…)
4.4 API WEIGHING RECORD:
Quantity weighed Packed in Cont./ Verifica-
Sr. Quantity Cage No. Weighed Ckd. by / Ckd. by / tion at the
Item Theoret- Retest
No. Ingredients Grade LOT UOM to be A.R. No. Gross Tare Net Balance no. by/ date date date staging
Code ical Qty. Date
Weighed Wt. Wt. Wt. Container Cage (Store) (Prod.) (IPQA) area by
Prod
API

III kg
280.000 280.000

RADM162/ Total
Metformin Ph.
1. RADM110
Hydrochloride Eur.

IV 280.000 280.000
kg

Total
Note : Photocopy of API weighing record shall be retained as the Store copy.
No. of Cages / Container transferred to Staging Area by Stores No. of Containers ……………… No. of Cages ……………. Stores (Sign/Date)………………
No. of Cages / Container received at Staging Area by Production No. of Cages ……………. No. of Containers ……………… Prod. (Sign/Date)………………..

BMR:TMT:DS:01, Page 11 of 12
Prepared by: Approved by:

Site Quality Assurance Site Quality Assurance Head

Date
L:004:BMSRN/C
 MICRO LABS LIMITED, VERNA-GOA (ML06) Page 12 of 84
BATCH MANUFACTURING RECORD Batch Size: 2,240,000 Tablets
Product Metformin 500 mg Tablets EU BMR No.: BMR1:MOAHG:UK01/R6
Generic Name Metformin 500 mg Tablets Batch No.: MOAG

BMR COPY / STORE COPY

4.0 RAW MATERIAL WEIGHING RECORD: (FOR COATING) (Continued…)
4.5 EXCIPIENT WEIGHING RECORD:
Mark “√” to indicate the number of coating lots 3 4 Production Head (Sign / Date)__________

Quantity to Quantity weighed Packed in Verificati

Sr. Theoretical Qty.
Item be Weighed Retest Balance Cont./Cage No. Weighed Ckd. by / on at the
no Ingredients Grade LOT UOM A.R. No. Gross Tare Net by/ date date staging
Code Date no.
# ## # ## Wt. Wt. Wt. Container Cage (Store) (Prod.) area by
Prod
Coating Material

I kg 14.933 11.200 14.933 11.200

Total

II kg 14.933 11.200 14.933 11.200

Opadry Total
REND
1. Y1-7000H IH
219
White
III kg 14.933 11.200 14.933 11.200

Total

IV kg 11.200 11.200

Total
Note : 1. Photocopy of Excipients weighing record shall be retained as the Store copy.
2. # Applicable in case of Three lots coating in Neocota 500.## Applicable in case of Four lots coating in Neocota 60 A.
No. of Cages / Container transferred to Staging Area by Stores No. of Containers ……………… No. of Cages ……………. Stores (Sign/Date)………………
No. of Cages / Container received at Staging Area by Production No. of Cages ……………. No. of Containers ……………… Prod. (Sign/Date)………………..

BMR:TMT:DS:01, Page 12 of 12
Prepared by: Approved by:

Site Quality Assurance Site Quality Assurance Head

Date
L:004:BMSRN/C