BATCH MANUFACTURING RECORD

Product Name : Batch No. Document No. BMR/TAB/0012 Version 01 Effective Date 01.01.2013
Elfexo 120 Tablet
Leon Pharmaceuticals Ltd.
Product Code : EFT012 Strength Fexofenadine Hydrochloride Batch Size Manufacturing Date Expiry Page 1 of 13
120 mg Date
Compiled By Checked By Approved By Authorized By

PD Officer Production Officer QA Officer (Production Manager) QA Manager

Precautions:
1. The operator and personnel wear protective clothing , caps , hand gloves , nose mask and working sandal 4. The personnel working at the manufacturing area must have a good state of
during manufacturing to protect him/her self against raw materials that might be coming into contact with the skin and inhaling into lungs. Health and should show qualities of neatness and orderliness.
2. All manufacturing area must be cleaned before going to production. 5. All manufacturing operations will be conducted in compliance with good
3. All manufacturing equipment must be thoroughly cleaned and dried before using as per standard operating procedure (SOP) . manufacturing practice (GMP)

Formulation & Dispensing

Sl. Material Material Name Specification QA Reference Standard Standard Potency% Quantity Unit Weighed Checked Date
No. Code No. Qty. / Tablet Qty. / Batch Dispensed By By

01 LAI-056 Fexofenadine Hydrochloride USP 120.00 mg Kg

02 LII-019 Lactose BP 35.00 mg Kg
03 LII-025 Microcrystalline Cellulose (Avicel PH 101) BP 27.00 mg Kg
04 LII-034 Povidone K 30 BP 6.00 mg Kg
05 LII-046 Sodium Starch Glycolate BP 10.00 mg Kg
06 LII-021 Magnesium Stearate BP 2.00 mg Kg

Coating Materials
09 kg
10 kg
11 kg
12 kg
13 kg
14 Lit
13 Lit

Issued By: ______________ Checked By: ________________ Checked By: _______________ Supplied By: ______________ Received By: _______________
Production Officer Production Manager QC/QA Officer Store Officer Production Officer
Date: Date: Date: Date: Date:

Theoretical Yield : Total Man Hour Used :

Actual Yield : Start Time:
% of Yield : End Time:
 BATCH MANUFACTURING RECORD

Product Name : Batch No. Document No. BMR/TAB/0012 Version 01 Effective Date 01.01.2013
Elfexo 120 Tablet
Leon Pharmaceuticals Ltd.
Product Code : EFT012 Strength Fexofenadine Hydrochloride Batch Size Manufacturing Date Expiry Page 2 of 13
120 mg Date
Compiled By Checked By Approved By Authorized By

PD Officer Production Officer QA Officer (Production Manager) QA Manager

CALCULATION
Note:1
Calculate the actual amount of Fexofenadine Hydrochloride as follows:

Current potency of Fexofenadine Hydrochloride = %

Theoretical quantity per tablet x 100 x Batch Size

Actual amount required = -------------------------------------------------------------------- kg
Potency x 1000 x 1000

= -------------------------------------------------------------------- kg

= kg

Calculation Done By: _______________________ Calculation Checked By: _____________________

(Production Officer) (QC Officer)
Date: Date:
 BATCH MANUFACTURING RECORD
Product Name : Batch No. Document No. BMR/TAB/0012 Version 01 Effective Date 01.01.2013
Elfexo 120 Tablet
Leon Pharmaceuticals Ltd.
Product Code : EFT012 Strength Fexofenadine Hydrochloride Batch Size Manufacturing Expiry Date Page 3 of 13
120 mg Date
Compiled By Checked By Approved By Authorized By

PD Officer Production Officer QA Officer (Production Manager) QA Manager

Change Over Clearance for Dispensing
Name of the Equipment/ Area Equipment ID No. / Previous Product Batch No. Date Cleaned By Checked By Verified By
Area or Room No. (Production Officer) (QC Officer)
Dispensing Room
Dispensing Booth
Balance
Utensils

Processing Steps Date Temp RH% Done By

Step-1 :
Temperature and Humidity Checking: Check the temperature and humidity of the area.

Temperature : (Range: 20 0 C to 250 C)

Relative Humidity: (Range: 30% to 40% )

Start Time End Time Done By

Step-2 :
Loss On Drying (LOD) Checking: Be sure the Loss On Drying (LOD) of Lactose, Microcrystalline Cellulose (Avicel PH 102) is less than
1%

Step-3 :
Raw Materials Weighing: Weigh the Lactose, Microcrystalline Cellulose (Avicel PH 102), Magnesium Stearate, Hypromelose, Titanium
Dioxide, Polyethylene Glycol, Dichloromethane, Isopropyl Alcohol and Fexofenadine Hydrochloride by using Balance.
 BATCH MANUFACTURING RECORD

Product Name : Batch No. Document No. BMR/TAB/0012 Version 01 Effective Date 01.01.2013
Elfexo 120 Tablet
Leon Pharmaceuticals Ltd.
Product Code : EFT012 Strength Fexofenadine Hydrochloride Batch Size Manufacturing Date Expiry Page 4 of 13
120 mg Date
Compiled By Checked By Approved By Authorized By

PD Officer Production Officer QA Officer (Production Manager) QA Manager

Change Over Clearance for Granulation Area

Name of the Equipment/ Area Equipment ID No. / Previous Product Batch No. Date Cleaned By Checked By Verified By
Area or Room No. (Production Officer) (QC Officer)
Mass Mixer
Fluid Bed Dryer
Shifter

Change Over Clearance for Blending

Name of the Equipment/ Area Equipment ID No. / Previous Product Batch No. Date Cleaned By Checked By Verified By
Area or Room No. (Production Officer) (QC Officer)
Drum Mixer
20 mesh SS Screen
Utensils
Polythene and Drum

Room Temperature and Relative Humidity Control Sheet During Blending

Control the Temperature and Relative Humidity as per the following specification and record.
Specification
Room Temperature: 200 C to 250 C Relative Humidity: Range: 30% to 40%
Date Time Temperature (0C) % of Relative Humidity Recorded By Checked By

BATCH MANUFACTURING RECORD

 Product Name : Batch No. Document No. BMR/TAB/0012 Version 01 Effective Date 01.01.2013
Elfexo 120 Tablet
Leon Pharmaceuticals Ltd.
Product Code : EFT012 Strength Fexofenadine Hydrochloride Batch Size Manufacturing Date Expiry Date Page 5 of 13
120 mg
Compiled By Checked By Approved By Authorized By

PD Officer Production Officer QA Officer (Production Manager) QA Manager

Processing Steps Date Start Time End Time Done By Checked By

Step-4 :
Blending Materials Sieving: Sieve all the blending materials through 20 mesh SS Screen.

Processing Steps Date Start Time End Time Done By Checked By

Step-5 :

Rework Addition: Add recovery of previous product (if any) after crushing through Multi-Mill using 0.5 mm pore size SS net
then sieving through 20 mesh SS Screen.
(Note: Add not more than 5% recovery of previous batch of same product that must be passed by QC during
addition of recovery and should be checked by Production Officer)

Quantity Added = Kg. Batch Number:

 BATCH MANUFACTURING RECORD

Product Name : Batch No. Document No. BMR/TAB/0012 Version 01 Effective Date 01.01.2013
Elfexo 120 Tablet
Leon Pharmaceuticals Ltd.
Product Code : EFT012 Strength Fexofenadine Hydrochloride Batch Size Manufacturing Date Expiry Page 6 of 13
120 mg Date
Compiled By Checked By Approved By Authorized By

PD Officer Production Officer QA Officer (Production Manager) QA Manager

Processing Steps Date Start Time End Time Done By Checked By

Step-6 :
Blending: Take the sieved Raw Materials into the Drum Mixer. Blend the materials for 40 minutes.

After blending check the LOD at 1000C and record it below.

LOD Range : NMT 3%

LOD Result :______________

Step- 7:
Blended Material Preservation:
a. After the completion of the blending, inform QC personnel to take blending sample through the In-Process Analysis
request and Report Sheet.
b. After getting the approval from QC, take polythene bag placed in a clean SS drum or a plastic drum and weigh.
c. Discharge the blended in the polythene bag placed in a clean SS drum or a plastic drum and weigh again. Label the
drum properly with product name, batch number, gross weight, tare weight, net weight and container number.
d. Transfer the blended for compression.

Theoretical Yield: ____________________ Kg (including recovery)

Actual Yield : ____________________ Kg; % of Yield: _____________________

BATCH MANUFACTURING RECORD

 Product Name : Batch No. Document No. BMR/TAB/0012 Version 01 Effective Date 01.01.2013
Elfexo 120 Tablet
Leon Pharmaceuticals Ltd.
Product Code : EFT012 Strength Fexofenadine Hydrochloride Batch Size Manufacturing Date Expiry Page 7 of 13
120 mg Date
Compiled By Checked By Approved By Authorized By

PD Officer Production Officer QA Officer (Production Manager) QA Manager

Change Over Clearance for Compression

Name of the Equipment/ Area Equipment ID No. / Previous Product Batch No. Date Cleaned By Checked By Verified By
Area or Room No. (Production Officer) (QC Officer)
Compression Room
Tablet Compression Machine
Hopper
Balance
Polythene and Drum

Room Temperature and Relative Humidity Control Sheet During Compression

Control the Temperature and Relative Humidity as per the following specification and record.

Specification
Room Temperature: 200 C to 250 C Relative Humidity: Range: 30% to 40%
Date Time Temperature (0C) % of Relative Humidity Recorded By Checked By
 BATCH MANUFACTURING RECORD
Product Name : Batch No. Document No. BMR/TAB/0012 Version 01 Effective Date 01.01.2013
Elfexo 120 Tablet
Leon Pharmaceuticals Ltd.
Product Code : EFT012 Strength Fexofenadine Hydrochloride Batch Size Manufacturing Date Expiry Page 8 of 13
120 mg Date
Compiled By Checked By Approved By Authorized By

PD Officer Production Officer QA Officer (Production Manager) QA Manager

Processing Steps Date Start Time End Time Done By Checked By

Step-8:
Compression: Compress the blended materials into tablet according to following specification and inform QC personnel to
take sample through the In-Process Analysis Request and Report Sheet.

Die-Punch Size and Shape: 9 mm round concave.

Weight per Tablet: 200 mg
Average Weight Range: 200mg 3%
Individual Weight Range: 200mg 5%
Hardness: NLT 3.0 kg
Diameter: 9.0 mm to 9.2 mm
Thickness: 3.7 mm to 4.1 mm
Friability: Not more than 1.0%
Disintegration Time: Not more than 15 minutes.
Step-9:
Compressed Tablet Preservation: After getting the approval from QC, continue the compression and preserve the
compressed tablet in double polythene bag placed in a drum. Label the drum properly with Product Name, Batch Number,
Gross Weight, Tare Weight, Net Weight and container Number.
 BATCH MANUFACTURING RECORD
Product Name : Batch No. Document No. BMR/TAB/0012 Version 01 Effective Date 01.01.2013
Elfexo 120 Tablet
Leon Pharmaceuticals Ltd.
Product Code : EFT012 Strength Fexofenadine Hydrochloride Batch Size Manufacturing Date Expiry Page 9 of 13
120 mg Date
Compiled By Checked By Approved By Authorized By

PD Officer Production Officer QA Officer (Production Manager) QA Manager

In-Process Control Sheet during Compression

a. Average and Individual Weight of 10 Tablets:
Average Wt. Individual Weight ( 237 mg to 262 mg) Weighed By
Date Time
(mg) 1 2 3 4 5 6 7 8 9 10 (Production/QC Officer)

BATCH MANUFACTURING RECORD

 Product Name : Batch No. Document No. BMR/TAB/0012 Version 01 Effective Date 01.01.2013
Elfexo 120 Tablet
Leon Pharmaceuticals Ltd.
Product Code : EFT012 Strength Fexofenadine Hydrochloride Batch Size Manufacturing Date Expiry Page 10 of 13
120 mg Date
Compiled By Checked By Approved By Authorized By

PD Officer Production Officer QA Officer (Production Manager) QA Manager

b. Hardness (in kg/cm2) of 10 Tablets:

Average Individual Hardness ( 3 kg/cm2 to 5 kg/cm2) Performed By
Date Time
Hardness 1 2 3 4 5 6 7 8 9 10 (Production/QC Officer)

c. Disintegration Time of 10 Tablets:

DT( NMT 15min) Performed By
Date Time
1 2 3 4 5 6 7 8 9 10 (Production/QC Officer)

c. Friability of 10 Tablets:
Performed By
Date Time Initial Weight Final Weight Friability(%)
(Production/QC Officer)

BATCH MANUFACTURING RECORD

 Product Name : Batch No. Document No. BMR/TAB/0012 Version 01 Effective Date 01.01.2013
Elfexo 120 Tablet
Leon Pharmaceuticals Ltd.
Product Code : EFT012 Strength Fexofenadine Hydrochloride Batch Size Manufacturing Date Expiry Date Page 11 of 13
120 mg
Compiled By Checked By Approved By Authorized By

PD Officer Production Officer QA Officer (Production Manager) QA Manager

Compression Yield:
Theoretical Yield of Tablets (in nos.)
Actual Yield of Tablets (in nos.)
Percentage of Yield
Name of the Equipment/ Area
Coating Room
Tablet Coating Machine
Coating Solution Passing Pipe
Coating Solution Vessel
Net Wt. of Granules Calculation Done By: _____________________
= ----------------------------------------- = = (Production Officer)
Std Wt. of one Tablet
Date: __________________________________
Net Wt. of Compressed Tablets
= ----------------------------------------- = =
Avg. Wt of Tablets Calculation Checked By: ___________________
(QC Officer)
Actual Yield of Tablets X 100
= ----------------------------------------- = = Date:___________________________________
Theoretical Yield of Tablets
Change Over Clearance for Coating
Equipment ID No. / Area Previous Product Batch No. Date Cleaned By Checked By Verified By
or Room No. (Production Officer) (QC Officer)

BATCH MANUFACTURING RECORD

 Product Name : Batch No. Document No. BMR/TAB/0012 Version 01 Effective Date 01.01.2013
Elfexo 120 Tablet
Leon Pharmaceuticals Ltd.
Product Code : EFT012 Strength Fexofenadine Hydrochloride Batch Size Manufacturing Date Expiry Page 12 of 13
120 mg Date
Compiled By Checked By Approved By Authorized By

PD Officer Production Officer QA Officer (Production Manager) QA Manager

Room Temperature and Relative Humidity Control Sheet During Coating
Control the Temperature and Relative Humidity as per the following specification and record.
Specification
Room Temperature: 200 C to 250 C Relative Humidity: Range: 30% to 40%
Date Time Temperature (0C) % of Relative Humidity Recorded By Checked By

Processing Steps Date Start Time End Time Done By Checked By

Step-10:

Coating Solution Preparation:

a. Filter Dichloromethane and Isopropyl Alcohol.
b. Sieve the other coating materials through 20 mesh SS screen.
c. Prepare the coating solution by mixing all coating materials.

Step-11:

Core Tablet Coating: Coat the core tablet with coating solution.

Step-12:

Coated Tablet Preservation: After getting the approval from QC, continue the compression and preserve the compressed
tablet in double polythene bag placed in a drum. Label the drum properly with Product Name, Batch Number, Gross Weight,
Tare Weight, Net Weight and container Number.
BATCH MANUFACTURING RECORD
Product Name : Batch No. Document No. BMR/TAB/0012 Version 01 Effective Date 01.01.2013
Elfexo 120 Tablet
Leon Pharmaceuticals Ltd.

Product Code : EFT012 Strength Fexofenadine Hydrochloride Batch Size Manufacturing Date Expiry Page 13 of 13
120 mg Date
Compiled By Checked By Approved By Authorized By

PD Officer Production Officer QA Officer (Production Manager) QA Manager

Remarks (Record Any Deviations):

Document Reviewed By :

Production Officer QA Officer Production Manager QA Manager