Bionext Pharma Pvt. LtdBionext Pharma Pvt. LtdPlot No C-373, T.T.C Industrial Area, Pawane, Plot No C-373, T.T.C Industrial Area, Pawane,
Navi Mumbai 400 705, Maharashtra, INDIANavi Mumbai 400 705, Maharashtra, INDIA
Quality Policy 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 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.
Facility USP 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.
Accreditations and Regulatory Accreditations and Regulatory Approvals Approvals WHO-GMP CERTIFICATE c-GMP CERTIFICATE
Facility Highlights 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.
Facility Description 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 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 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 featuresQuality featuresMaterial 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 pesonnel
Quality FeaturesQuality Features
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