cough syrups by bionext pharma private limited
TRANSCRIPT
Bionext Pharma Pvt. LtdPlot no c-373, T.T.C Industrial Area
MIDC, Pawane, Navi Mumbai 400 705, Maharashtra, INDIA
Quality Policy
A clear, written down Quality Policy which projects the
company's vision and the management's commitment to Quality,
the compliance to standards going beyond customer satisfaction
to customer delight and achieving the Quality objective through
its infrastructure and work practices is in place .
Bionext Pharma Pvt. Ltd., a manufacturing facility for
Liquid Orals is Pledged To Ethics for manufacturing of
quality drug products that consistently meet the laid
down standards by adhering to current Good
Manufacturing Practices (cGMP) in its facility,
endeavors to delight the Customers through its unique
and cost effective formulations and timely quality
services” .
Location
Situated in a Pollution free zone of T.T.C Industrial area of
Navi Mumbai in PAWANE MIDC
AT A DISTANCE OF :
2 Kms from Mumbai – Pune National Highway
25 Kms from Mumbai International Airport
20 Kms from Jawaharlal Nehru Port Trust (JNPT)
10 Kms from Upcoming International Airport at Panvel.
Site photo
Site Map
Facility USP DEDICATED FORMULATION – LIQUID ORAL UNIT
No chances of cross contamination and mix-ups
STATE OF THE ART FACILITY WITH Minimal MMI ( Man Machine Interface) .
Closed Manufacturing Facility .
Separate Manufacturing Vessels for different products and batches.
CIP (Cleaning in place ) system for cleaning of vessels.
No use of potable water in the process areas.
Dedicated Air Handling System for critical and non critical areas.
Automised Purified Water generation and distribution system with generation capacity of 2000 Litres per hour.
In house testing facility for chemical, instrumental and microbiological analysis.
3 Tier Electrical safety system.
Facility Highlights
Total Built-up Area : 24000 Sq Ft
WHO-GMP Certified Facility.
Strategically located for Domestic as well as Export
work.
Abundant availability of Technical staff and skilled /
semi skilled labour.
Fairly large capacity Having broad range of products.
Product development as per party requirement.
Major Clientelle includes Appy Overseas ( Merchant
Exporter), Aristo Pharma, Genom Biotech, Indoco
Remedies, Lupin, Mayer Organics, Zuventus
Healthcare.
Accreditations and Regulatory
Approvals WHO-GMP CERTIFICATE c-GMP CERTIFICATE
Facility Description Total Built up area : 25000 sq ft.
Modular wall panels sandwiched with puff insulation in between
both sides 0.8 mm G.I powdered sheet.
Doors made up of Single leaf puff filled with puff insulation in
between both sides with both side flushed glass view panel.
5 mm Hilux jointless sheets with cutouts for diffusers, light
fittings and coated with 2 coats of white latex paint antifungal in
nature with primer.
Ceiling made up of Single skin walkable false ceiling made out
of 24 G/0.6 mm G.I powder coated panel including cutouts for
diffusers, light fittings.
Floor with Hard Granite tiles with flush skirting in non process
areas.
Epoxy flooring in process areas with flush coving.
Current output capacity
Product Category Qty per Annum Quantity per Annum
Liquid Orals 3500 Kilolitres / year 35,000,000 Bottles of
100 ml per year
Future additional capacity
Product Category Qty per Annum Quantity per Annum
Liquid Orals 2000 Kilolitres / year 20,000,000 Bottles of
100 ml per year
Quality features
Material Movement
Material
Receipt
at Gate &
Intimation to
Stores
Vehicle containing Material
forwarded to Receiving bay
docking area
Condition of vehicle
checked & upon
satisfaction by Stores
allowed to unload Material
Material
unloaded in
Receiving bay
Material container
dedusted and
weighed
Material transferred to
Quarantine area
Material inwarded
and GRN to QC
Material Sampled and
transferred to Under test
area
Released Material
transferred to Approved
material area
Approved material
dispensed as per
Prod requirement
Quality Control system
Receipt of GRN
from Stores
Entry of material details
in Inward register
Sampling of
Material
Under test label on
Sampled consignment
Testing of
Material
Approval /
Rejection
of Material
If Released
Affix Approved Label
If Rejected
Affix Rejected Label
Calibration of
Instruments
Calibration of Volumetric Solutions
Disposed off in presence
of QA / Stores personnel
Quality Features
Quality Features
Procedure for the release of finished products
Bulk manufactured Intimation to QC QC Analysis
Upon Approval Intimation to
Production for Filling & Packing
Filing packing
done
Intimation to QA/QC for
FG Sampling QC Analysis
Upon Approval Intimation
to QA to release for sale
& distribution
Intimation to Stores by QA
for Dispatch
Transfer to FG Stores
Filling & Packing Area
Stores Area
Quality Control Area
Manufacturing Area
Lobby Area
We Manufacturing products for