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Bionext pharma
1. Bionext Pharma Pvt. Ltd
Plot No C-373, T.T.C Industrial Area, Pawane,
Navi Mumbai 400 705, Maharashtra, INDIA
2. 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
3. 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.
6. Facility USP
DEDICATED FORMULATION – LIQUID ORAL
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.
8. Facility Highlights
Total Built-up Area : 24000 Sq Ft
WHO-GMP Certified Facility.
Strategically located for local 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 Mayer Organics, Lupin,
Zuventus Healthcare, Aristo Pharma, Genom Biotech,
Appy Overseas ( Merchant Exporter), Indoco
Remedies.
9. 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.
10. 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
11. Quality features
Material Movement
Material
Receipt
Vehicle containing Material Condition of vehicle
at Gate &
forwarded to Receiving bay checked & upon
Intimation to
docking area satisfaction by Stores
Stores
allowed to unload Material
Material container Material
Material inwarded Material transferred to
and GRN to QC Quarantine area
dedusted and unloaded in
weighed Receiving bay
Material Sampled and Released Material Approved material
transferred to Under test transferred to Approved dispensed as per
area material area Prod requirement
12. Quality Features
Quality Control system
Receipt of GRN from Entry of material details in Sampling of
Stores Inward register Material
Approval / Rejection Under test label on
Testing of Material
of Material Sampled consignment
Calibration of Instruments
If Released
Affix Approved Label
Calibration of Volumetric Solutions
If Rejected Disposed off in presence of
Affix Rejected Label QA / Stores pesonnel
13. Quality Features
Procedure for the release of finished products
Bulk manufactured Intimation to QC QC Analysis
Filing packing Upon Approval Intimation to
Transfer to FG Stores
done Production for Filling & Packing
Upon Approval Intimation
Intimation to QA/QC for
QC Analysis to QA to release for sale
FG Sampling
& distribution
Intimation to Stores by QA
for Dispatch
