NGB Laboratory

instrumental chemist(well versed with Shimadzu 21 CFR part 11 software)

About Us

NGB Laboratories Pvt. Ltd. is a surat based, WHO GMP certified pharmaceutical company, established in 2017 with the vision of making world class affordable medicines. NGB Laboratories is a research driven forward looking pharmaceutical company with expertise in development of various finished dosage.Since its inception NGB Laboratories has been focused to manufacture niche pharmaceutical formulation products.The plant is a greenfield unit, designed by experts under our supervision. Given the importance of integrity of data to quality and GM…Read More

Our Products

Infrastructure

SALIENT FEATURES OF MANUFACTURING:

• Manufacturing facilities designed to conform to EU and FDA cGMP regulations.

• Three manufacturing suites – FLP Wet granulation ( RMG/FBD), Dry granulation ( Roll compactor), Oral Dry Powder ( RCVD)

• Compression ( AWC instrumented press 10 ton precompresion, 10 ton main compression)

• Alu – Alu Blister packing ( with vision inspection system)

• Capsulation section ( 90,000 capsules/hour) with pneumatic powder transfer

• Purified water distribution with RO , EDI , PLC based distribution system.

• Each module has separate AHUs with terminal HEPA filters to prevent cross contamination.

• Facilities conform to class 100,000 requirements, with 37 numbers of frameless AHUs & Low Humidity 20% via

steam heated dehumidifier.

• EMS system installed for Temperature, Humidity, Pressure differential

• PLC control and Data Loggers in place.

• Closed system material handling, with localized dust extraction.

• CIP (Clean in Place) pressure tank and IR Dryers installed

• In-House garment washing machine and Dryer

• Separate men and materials’ entry.

• Internal partition made of modular panels.

• All weighing balances from Mettler.

LABORATORY EQUIPMENT

• Dedicated server for laboratory instuments.

• Analytical balances Mettler

• HPLC , FTIR, UV, TOC Shimadzu

• 4 Walk in Stability Chambers, 1 Photostabilty chamber as per ICH guidelines.

• 5 BOD chambers, 4 LAF , double door autoclave , MilliQ and various other instruments

SAFETY

• Fire Hydrant system

• Smoke and multipoint detectors

• Manual call points

• CCTV

UTILITIES

• Gas powered boiler (capacity 2000 kg/hr) & common steam supply both avaiable.

• 750 KVA DG

• 60 KVA & 40 KVA UPS

• 2 Chillers (capacity 195TR)

• 2 Cooling towers (capacity 210 ton)

• Zero discharge ETP plant

Quality Management

At NGB Laboratories, we believe that the best quality product brings in a happy and satisfied customer. We at NGBL also believe that the quality of the product can be achieved with good design &monitoring all the phases of the product. We make a clear distinction within the quality management system (QMS) with respect to all our objectives, structures, data, processes, management review and continuous improvement. We have made conscious investments in systems that ensure compliance with G…Read More

Assurance

The Quality Assurance Department is assigned with but not limited to the following responsibilities:…

Control

Adequate testing areas are provided.

CHEMICAL SECTION

INSTRUMENTATION SECT…

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Policy

“We at NGB Laboratories are committed to ensuring that all the products manufactured and distribut…

OVERVIEW

The company will have dedicated formulation development department well equipped with the latest equipment’s and is supported by qualified of… read more