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P.3.2 Manufacturing process and Process Controls

PROCESS STEPS

DISPENSING

Dry Mixing

Dry mixed Materials, Rest

pad of Sodium Starch
Glycolate, Colloidal silicon
Dioxide (Aerosil-200),
Magnesium Stearate

F Blended Granules

Coated Tablet, Packaging

material (Aluminum top and
Bottom Foil)

Prepared ot, Checked by: t ,/ Approved by:

^rhana.
ol(ay lttf fir*ry\oetrq -S=sS vq'l\
PD Officer Sr. Executive. PD OAManaser
 Veritas Pharmaceuticals Ltd.
tferitas Muradpur, Vanna ra, Moucha k, Ka lia koi r, Gazi pur

b) Manufacturinq and packaqinq process description:

The manufacturing process includes the following stages:
All incoming raw materials are previously controlled for conformity with the laid down specifications"
The area and the equipments are clean and free from previous product before product changeover.
All balances are calibrated.

Stage 1 Weiqhinq of lnsredients:

Weigh Montelukast Sodium, Sodium starch Glycollate, Colloidal Sillicon dioxide (Aerosil-200), Magnesium
Stearate and Microcrystalline Cellulose (Avicel PH 102) according to Master Batch Formula and keep in to
separate container.

Stage 2 Sievins:
Sieve Montelukast Sodium, Sodium starch Glycollate, Microcrystalline Cellulose (Avicel Pl-i 102) through mesh #
20/24 using vibro shifter"

Stage 3 Drv Mixinq:

Take total Montelukast sodium, Microcrystalline Cellulose (Avicel PH 102) and part of Sodium Starch Glycollate in
to pillar bin blender and blend for 35 minutes.
Stage 4 Blendinq:
Add the rest part of Sodium starch Glycolate, Colloidal Sillicon Dioxide (Aerosil - 200) and Magnesiun Stearate
with dry mixed materials of step-3 in to pillar bin blender and blend for 10 minutes.
Collect granule for in-process control.

Stage 5 Release for Compression

Tests carried out:
Description, LOD and Assay.

Stage 6 Tablettinq
After QA release compress the granules by B-type tablet press according to specification.
Collect compressed tablets for in-process control.
Product lnspection, Hardness, Thickness, Diameter, Friability loss, Average weight and its variation.

Stage 7 Release for Coatinq

a
Tests carried out:
Description, Hardness, Thickness, Diameter, Friability loss, Average weight and its variation, Assay, LOD/
Moisture content.
Stage 8 Coatins:
After QA release start coating procedures.
Weighing of lngredients:
Opadry ll White 85G58921 and purified water, according to Master Batch formula.
Stage 9 Preparation of coatinq solution
Take Opadry ll 85G58921 White and Purified Water into a solution tank. Mix well by stirrer for 30 minutes. Filter
the polymer dispersion using '100 mesh.
Stage 10 Coatinq Procedure
a Pour core tablet into the coating pan.
b Set the pan at 2 rpm and at 65"C inlet temperature.
C Run the pan for 10 minutes with to dry and dedust the tablets.
d weigh 100 tablets and record average weight in the Batch yield Records sheet.
e Switch on the blower and exhaust.
f Set lnlet Temperature: 40"C-55'C
Exhaust Temperature: 25'C-45"C
Panspeed:3-6rpm
Spray Pump Speed: 10-30 rpm
Atomizing air Pressure 2.00 - 3.00 kg/cm,
g Start spray keeping all records in coating record sheet.

Prepared by: {6^yl+,r-,x Checked by: Approved by:

aq(6 5 I ut
$pq&^Mo-.,,llrt -Wr^fq, b q.l y
PD Officer Sr. Executive, PD QA Manager
 Veritas Pharmaceuticals Ltd.
vbritas Muradpur, Vanna ra, Moucha k, Kalia koi r, Gazipur

h After completion of spraying allow the tablets to dry for 10 minutes at 450C lnlet Temperature with
intermittent jogging of tablets.
i Weigh 100 tablets and record average weight in Batch Yield Record Sheet

Stage 11 Collect coated sample for in-process control.

Product lnspection, Average weight & its variation.

Stage 12 Release for Packinq

Tests carried out:
Product lnspection, ldentification, Diameter, Thickness, Dissolution, average weight & its variation"

Stage 13 Blisterinq
Upon approval, strip the tablets through blister machine bearing batch no, expiry date according to batch
packaging record.

Stage 14 Collect sample of stripped tablets for in-process control.

Leak test,

Stage '15 Cartoninq

Pack the correct quantity of stripped tablets inside the carton with the same batch no, mfg & expiry date and the
enclose one product leaflet.

c) ln process Control:

Step/Stage Parameter Frequency Limits

At the stage of Machinery & area Once before starting Clean, free from contamination of previous
01
orocessino clearance oroduct
Appearance 0nce White qranular powder.
02 Blend
Moisture Content Once on Blending NMT 3.5%
Description Every 15 min A white-to off-white colored, round shaped
tablet wrlh "V" engraved on one side & other
side break line
Average weight of 10 Every 15 min 0.903 g to 0.998 g (0.95 g t 5.0%)
Tablets
Compression Uniformitv of weioht Every 15 min !.5Y0
03
Hardness Every t hour NLT 3.5 kp
Friability Everv t hour NMT 1%
Thickness Everv 15 min 2,90 mm - 3,25 mm (3.10 mm t 5%)
Disinteqration Time Everv t hour NMT 15 minutes
Temperature Every 15 min 22!.2'C
Humidity Every 15 min 5015%
Machinery & Area Once before coating Clean, free from contamination of previous
04 At the Start of Coating
clearance oroduct
Appearance Once after coating A white to off-white colored, round shaped
film coated tablet with break line on one side
05 At the end of coating
& other side engraved with "V".

Prepared Ay:
fv,r L-o^"v.- Checked by: /- Approved by:
af l t+
la'> +n*^IYn-r t rr.t
PD Officer Sr. Executive, PD QA Manager