Gomti life sciences india pvt limited

Plot No. 17F, Bidadi Industrial AreaPlot No. 17F, Bidadi Industrial Area22ndnd Phase, Sector-1 Phase, Sector-1Bidadi.Bidadi.Ramanagara District-562 109Ramanagara District-562 109Karnataka, IndiaKarnataka, India

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over-view of the manufacturinG over-view of the manufacturinG facilityfacility

Gomti Life Sciences India Pvt Limited in located in KIADB, Bidadi. Gomti Life Sciences India Pvt Limited in located in KIADB, Bidadi. The plant is around 70Km from the international Airport.The plant is around 70Km from the international Airport.

Plant is located in Industrial Area Bidadi, It is ~ 70KM from the international air port.

Gomti Life Sciences India Pvt LtdGomti Life Sciences India Pvt Ltd

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surroundinG areasurroundinG area

The factory is surrounded on Four Sides as follows;The factory is surrounded on Four Sides as follows;

EastEast :: Private LandPrivate Land

WestWest :: 18 Mt. wide KIADB Road18 Mt. wide KIADB Road

NorthNorth :: Plot No. 17GPlot No. 17G

SouthSouth :: Plot No. 17 EPlot No. 17 E

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company profilecompany profile

Gomti Life Sciences India Pvt Limited, Established in August 2012, is an API manufacturer, focused on the regulated (US/European) markets.

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reGulatory approvalsreGulatory approvals

As the company is newly established and it is under start-up, no regulatory approvals are obtained as on date.

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human resourceshuman resources

Sl. No Department Strength

1 Engineering 182 Finance 033 Human Resources 074 Marketing 015 Production 206 Purchase 017 Quality Assurance / Regulatory

Affairs04

8 Quality Control 069 Research & Development 0610 Safety 0211 Warehouse 03

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orGanization chartorGanization chart

Sheshu G NavadaManager-QA

B. RavikumarManager-Production

Mahendra Kumar SharmaManaging Director

VeluchamyVice President-Operations

MG NarayanHead-Quality

Ramesh KumarManager-QC

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orGanization chart-operationsorGanization chart-operations

VeluchamyVice President-Operations

Ravikumar BHead-Production

Murugan PManager-Engg

Lokesh ASr. Manager-Warehouse

Ashok MSManager-HR

RangarajSr. Executive-Purchase

Krishnamurthy MSManager-Electrical

ManjunathManager-Maintenance

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Gomti Life Sciences India Private Limited wishes to become the preferred supplier to global pharmaceutical customers meeting the international regulatory requirements with the fullest possible customer satisfaction

Also;

Partner with global pharmaceutical industries

Actively file Drug Master Files

Ensure the compliance to the regulatory norms of the customers region

Obtain regulatory approvals from US,Europe,Japan etc.,

Continuously invest and build our intellectual property

vision……..vision……..

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To achieve growth in business by:

Delivering the products that meet the customer’s requirements, at the time when the customer needs them,

at the competitive cost expected by the customer and

thus fulfilling the expectation of all stakeholders.

mission………..mission………..

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1. Achieve customer satisfaction

2. Providing services and products of highest quality

3. Enhance wealth of share holders

4. Enhance health & wealth of employees

5. Preserve our environment

values……….values……….

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1. We are committed to manufacture and supply of Intermediates & Active Pharmaceutical Ingredients (APIs) within the frame work of applicable regulations / standards.

2. We also adhere to the timely delivery of the product and ensure the material safety till it reaches the customers.

3. We work for continuous improvement in the process which will be achieved through active involvement, co-ordination and collective responsibility of our trained & professional employees.

4. Conducting Internal Quality Audits and Management Review for an evaluation and improvement of our Quality System.

Quality Policy…….Quality Policy…….

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Site lay-outSite lay-out

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adminiStrative Block….adminiStrative Block….

ReceptionReception Administrative officeAdministrative office

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adminiStrative Block….adminiStrative Block….

Conference Conference HallHall

CanteenCanteen

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Warehouse is having the following:-

De-dusting areaSampling areaDispensing areaRejected RoomWashing roomFinished goods Storage areaRM and PM storage areaSeparate area for storage of solvents (Solvent yard and underground tanks)

Contamination from outside environment is controlled by

De-dusting material before moving to storage area Storage of material in allocated location Sampling and dispensing in the separate rooms with controlled environment Transporting the dispensed material through protected environment through hoists and aerobridge The finished product is handled only under the controlled environment The finished product after packing is transferred to finished product warehouse under protected environment

WarehouSe….WarehouSe….

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WarehouSe….WarehouSe….

RM StorageRM Storage PM StoragePM Storage Aerobridge For Material MovementAerobridge For Material Movement

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WarehouSe….WarehouSe….

Sampling roomSampling room Dispensing RoomDispensing Room

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Synthetic Laboratory:-Three fume cupboards Two Buchi Roto evaporators All required equipment to carry out synthetic reactions

KG Laboratory : Equipped with two numbers of 20L all glass assembly

Pilot Plant is equipped with:- Two MSGL reactors (160 L )Two SS 316 reactors ( 160L &200L) One SS 316 centrifuge ( 24”) One PP/FRP Nutche filter (18”) One FBDOne Doom filter Lab Hydrogenator (2.0 L and 100 bar pressure)

Laboratory : 1g-100 g.Kilo Laboratory : 100 g-1kg.Pilot Plant : 1kg-50 kg.

reSearch and develoPment….reSearch and develoPment….

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reSearch and develoPment….reSearch and develoPment….

R&D LabR&D Lab KG LabKG Lab

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reSearch and develoPment….reSearch and develoPment….

Pilot Plant-Ground FloorPilot Plant-Ground Floor Pilot Plant-First Pilot Plant-First FloorFloor

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Quality control lab has:Chemical analysis LabInstrumentation LabMicrobiology LabMain activity of QC Lab but not limited to ;

1.Sampling, analysis and release of raw materials, intermediate and finished product2.Maintenance of primary and certified reference standard3.Preparation and maintenance of working reference standard4.Preparation and maintenance of document as per cGMP requirement5.Handling of out of specification 6.Method development and validation for raw materials, intermediates and finished product 7.Cleaning method validation8.Water system qualification, clean room validation

Quality control ….Quality control ….

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Major equipMent list of quality control Major equipMent list of quality control ….….

Sl. No Equipment Make Numbers

1 High Performance Liquid Chromatograph Shimadzu 12 Gas Chromatograph Shimadzu 13 UV Spectrophotometer Shimadzu 14 Infrared Spectrophotometer Shimadzu 15 Stability Chambers Newtronic 36 Analytical Balance Mettler 27 pH Meter Eutech 18 Conductivity Meter Eutech 19 Karl Fischer Titrator Lab India 110 Hot Air oven Ally One 111 Vacuum Oven Osworld 1

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quality control….quality control….

Chemical analysis labChemical analysis lab Instrumentation labInstrumentation lab

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production……production……

1. Production facility is designed to meet the GMP requirement.Production facility is designed to meet the GMP requirement.

2. Production facility consists of three floors ( Ground, First and Second)Production facility consists of three floors ( Ground, First and Second)

3. Whole production facility is provided with controlled environment Whole production facility is provided with controlled environment

4. Technical area is under ventilated system Technical area is under ventilated system

5. Pharma area meets the requirement of ISO Class 8 Pharma area meets the requirement of ISO Class 8

6. Separate personnel entry and material entry are provided for the Pharma Separate personnel entry and material entry are provided for the Pharma Area Area

7. Air curtains are provided at all entry point to the production area from Air curtains are provided at all entry point to the production area from open environment open environment

8. All the waste water outlet in the Pharma area are provided with All the waste water outlet in the Pharma area are provided with sanitary drains sanitary drains

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Major equipMent list of production….Major equipMent list of production….

Sl. No Equipment Capacity Numbers MOC

1 Reactor 4000 L 3 SS-316

2 Reactor 4000 L 1 MS GLR

3 Reactor 3000 L 3 SS-316

4 Reactor 3000 L 2 MS GLR

5 Reactor 2000 L 1 SS-316

6 Reactor 2000 L 3 MS GLR

7 Reactor 630 L 1 MS GLR

8 Centrifuge 48” / 36” 1 / 2 SS-316

9 Nutche Filter 900 mm / 700 mm 2/1 SS-316

10 Sparkler Filter 18” 2 SS-316

11 Vacuum Tray Dryer 48 trays / 24 trays 1 /1 SS-316

12 RCVD 1 KL / 0.5 KL / 1 KL 1 / 1/ 1 SS-316 / SS-316 / MS GLR

13 Sifter 36 “ 2 SS-316

14 Multimill - 2 SS-316

15 Octagonal Blender 500 L 1 SS-316

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production….production….

EntranceEntrance

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production….production….

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production….production….

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production….production….

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production….production….

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Major equipMent in engineering….Major equipMent in engineering….

Sl. No Equipment Capacity Numbers Make

1 Air Compressor-Oil Free 200 CFM 1 Chicago Pneumatic2 Chilled water (5-10OC) 135 TR 3 Daikin3 Chilled Brine -15 OC 59 TR 1 Reynolds4 Cooling Tower 500 TR 1 Perfect5 Cooling Tower 350 TR 2 Perfect6 Boiler 600 Kg / Hr 4 Thermax7 Thermic Fluid Heater 2 L K Cal / Hr 1 Energy Machine8 Hot Water Generator 4 L K Cal / Hr 1 Thermax9 Vacuum Pump 50 M3 / Hr to

150 M3 / Hr9 Thoshniwal

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engineering ….engineering ….

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EnginEEring ….EnginEEring ….

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EnginEEring ….EnginEEring ….

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The responsibility of QA (but not limited to):-

1.Review, approval and execution of equipment qualification protocols.2.Approval of SOP, specification , test method and batch manufacturing record and maintenance of the above with history of changes.3.Documentary review and clearance of raw material, intermediate and finished product.4.Handling Deviation, OOS, Change control, CAPA, Customer complaint, Product recall etc.5.Planning and execution of internal audit, conducting Management Review and follow-up of the non conformance closure.6.Annual product quality review.7.Master validation plan and its execution.8.Vendor development / contract laboratory development.

Quality assurancE ……Quality assurancE ……

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aHu systEm ……aHu systEm ……

HVAC system is provided in the following areaHVAC system is provided in the following area

-Clean rooms in Manufacturing areaClean rooms in Manufacturing area-Microbiology LabMicrobiology Lab-Sampling and Dispensing room in the ware-houseSampling and Dispensing room in the ware-house-Filters 10, 5 and 0.3 micron.Filters 10, 5 and 0.3 micron.

-Technical area is provided with 20, 10 and 5 micron filters.Technical area is provided with 20, 10 and 5 micron filters.

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WatEr systEm ……WatEr systEm ……

• Raw water is obtained from the borewell.Raw water is obtained from the borewell.

• The Potable water generation system consists of under ground tank, where the water is The Potable water generation system consists of under ground tank, where the water is kept under continuous circulation with dosing of sodium hypochlorite solution, kept under continuous circulation with dosing of sodium hypochlorite solution, equivalent to 5 ppm of Chlorine.equivalent to 5 ppm of Chlorine.

• The water from tank is passed through Multigrade filter and thereafter with dosing of The water from tank is passed through Multigrade filter and thereafter with dosing of sodium meta bisulphite the water is passed through Duplex softeners. (Free chlorine sodium meta bisulphite the water is passed through Duplex softeners. (Free chlorine level in soft water is maintained between 1 to 2 ppm).level in soft water is maintained between 1 to 2 ppm).

• Soft water is pumped through to ultra filtration module, then through UV chamber and Soft water is pumped through to ultra filtration module, then through UV chamber and then collected in ultra filtered storage tank.then collected in ultra filtered storage tank.

• Ultra filtered water is then pumped with dosing of antiscalant solution, sodium Ultra filtered water is then pumped with dosing of antiscalant solution, sodium hydroxide solution and sodium meta bisulphite (free chlorine level will be maintained hydroxide solution and sodium meta bisulphite (free chlorine level will be maintained at zero ppm), Passes through RO membrane and the permeate water (Potable water) is at zero ppm), Passes through RO membrane and the permeate water (Potable water) is collected in potable water storage tankcollected in potable water storage tank

• The RO generation capacity is 6000L per hourThe RO generation capacity is 6000L per hour

WatEr systEm ……WatEr systEm ……

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• Potable water generated is pumped through 5 micron filter, then through RO Potable water generated is pumped through 5 micron filter, then through RO membrane and EDI unitmembrane and EDI unit

• The permeate water from EDI is the Purified water, which is stored in SS 316L tank.The permeate water from EDI is the Purified water, which is stored in SS 316L tank.

• From storage tank, purified water is passed through UV chamber and circulated in From storage tank, purified water is passed through UV chamber and circulated in loop covering respective user pointsloop covering respective user points

• The return line before tank passes through online conductivity instrument, if the The return line before tank passes through online conductivity instrument, if the conductivity of the return line water is not within the specified limits, the water is conductivity of the return line water is not within the specified limits, the water is dumped through the dump valvedumped through the dump valve

• The generation capacity of purified water is 1000L per hour.The generation capacity of purified water is 1000L per hour.

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safEty ……safEty ……

1. The entire facility is protected with fire hydrant system consists of ;-The entire facility is protected with fire hydrant system consists of ;-• Fire water pump house with diesel operated and electrically operated pumps Fire water pump house with diesel operated and electrically operated pumps

supported by jockey pump.supported by jockey pump.• 29 single fire hydrants.29 single fire hydrants.• 15 hose reel drums.15 hose reel drums.

2. The entire facility is provided with fire alarm system with smoke detectors The entire facility is provided with fire alarm system with smoke detectors installed in more than 200 locations.installed in more than 200 locations.

3. In addition to the above appropriate fire extinguishers will be installed in more In addition to the above appropriate fire extinguishers will be installed in more than 40 locations than 40 locations

4. 24/7 monitoring through CCTV cameras fitted in more than 70 locations24/7 monitoring through CCTV cameras fitted in more than 70 locations

5. Appropriate PPEs will be made available in the PPE boxes fitted in the Appropriate PPEs will be made available in the PPE boxes fitted in the required locations required locations

6. All the employees trained as per the emergency preparedness plan as All the employees trained as per the emergency preparedness plan as approved by the Director of Factories approved by the Director of Factories

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HEaltH ……HEaltH ……

1. Pre employment health check up and periodic health check Pre employment health check up and periodic health check will be carried out and health record will be maintained will be carried out and health record will be maintained meeting the statutory and regulatory requirementmeeting the statutory and regulatory requirement

2. Occupational Health Centre with all the required facility will Occupational Health Centre with all the required facility will be operational be operational

3. An ambulance with all the required facility and medicines will An ambulance with all the required facility and medicines will be available in the factory premises be available in the factory premises

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EnvironmEnt ……EnvironmEnt ……

1. The waste water generated from the manufacturing activities are The waste water generated from the manufacturing activities are segregated into lean waste stream and concentrated waste stream at segregated into lean waste stream and concentrated waste stream at the source itselfthe source itself

2. The lean waste generated is treated and the water is recovered by The lean waste generated is treated and the water is recovered by passing through Reverse Osmosis system and reused in the cooling passing through Reverse Osmosis system and reused in the cooling towers towers

3. The concentrated waste is sent to the common effluent treatment The concentrated waste is sent to the common effluent treatment plant approved by KSPCBplant approved by KSPCB

4. The hazardous waste generated is incinerated in the common The hazardous waste generated is incinerated in the common incinerator approved by KSPCBincinerator approved by KSPCB

5. Rain water harvesting facilities are installed as meeting the statutory Rain water harvesting facilities are installed as meeting the statutory requirement requirement

6. All the process equipment are connected to the scrubbersAll the process equipment are connected to the scrubbers

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