Gomti Life Sciences India Pvt Ltd is an Indian cGMP Toll manufacturing facility of Active Pharmaceutical Ingredients and Pharma intermediates. Manufacturing unit is state of the art, built to meet USFDA, EU-GMP standards.
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Gomti presetnation
1. Gomti life sciences india pvt
limited
Plot No. 17F, Bidadi Industrial AreaPlot No. 17F, Bidadi Industrial Area
22ndnd
Phase, Sector-1Phase, Sector-1
Bidadi.Bidadi.
Ramanagara District-562 109Ramanagara District-562 109
Karnataka, IndiaKarnataka, India
2. 2
over-view of the manufacturinGover-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 LifeSciencesIndiaPvt LtdGomti LifeSciencesIndiaPvt Ltd
3. 3
surroundinG areasurroundinG area
The factory is surrounded on FourSides as follows;The factory is surrounded on FourSides as follows;
EastEast :: Private LandPrivate Land
WestWest :: 18 Mt. wide KIADBRoad18 Mt. wide KIADBRoad
NorthNorth :: Plot No. 17GPlot No. 17G
SouthSouth :: Plot No. 17 EPlot No. 17 E
4. 4
company profilecompany profile
Gomti Life Sciences India Pvt Limited, Established in
August 2012, is an APImanufacturer, focused on the
regulated (US/European) markets.
9. 9
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
customersatisfaction
Also;
Partnerwith global pharmaceutical industries
Actively file Drug MasterFiles
Ensure the compliance to the regulatory norms of the customers
region
Obtain regulatory approvals from US,Europe,Japan etc.,
Continuously invest and build ourintellectual property
vision……..vision……..
10. 10
To achieve growth in business by:
Delivering the products that meet the customer’s requirements,
at the time when the customerneeds 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 customersatisfaction
2. Providing services and products of highest quality
3. Enhance wealth of share holders
4. Enhance health &wealth of employees
5. Preserve ourenvironment
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
foran evaluation and improvement of ourQuality System.
Quality Policy…….Quality Policy…….
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Warehouse is having the following:-
De-dusting area
Sampling area
Dispensing area
Rejected Room
Washing room
Finished goods Storage area
RMand PMstorage area
Separate area forstorage 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 underthe controlled environment
The finished product after packing is transferred to finished product warehouse under
protected environment
WarehouSe….WarehouSe….
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reSearch and develoPment….reSearch and develoPment….
Pilot Plant-Ground FloorPilot Plant-Ground Floor Pilot Plant-FirstPilot Plant-First
FloorFloor
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Quality control lab has:
Chemical analysis Lab
Instrumentation Lab
Microbiology Lab
Main activity of QC Lab but not limited to ;
1.Sampling, analysis and release of raw materials, intermediate and finished
product
2.Maintenance of primary and certified reference standard
3.Preparation and maintenance of working reference standard
4.Preparation and maintenance of document as percGMPrequirement
5.Handling of out of specification
6.Method development and validation for raw materials, intermediates and
finished product
7.Cleaning method validation
8.Watersystem qualification, clean room validation
Quality control ….Quality control ….
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Major equipMent list of quality controlMajor equipMent list of quality control
….….
Sl. No Equipment Make Numbers
1 High PerformanceLiquid Chromatograph Shimadzu 1
2 GasChromatograph Shimadzu 1
3 UV Spectrophotometer Shimadzu 1
4 Infrared Spectrophotometer Shimadzu 1
5 Stability Chambers Newtronic 3
6 Analytical Balance Mettler 2
7 pH Meter Eutech 1
8 Conductivity Meter Eutech 1
9 Karl Fischer Titrator Lab India 1
10 Hot Air oven Ally One 1
11 Vacuum Oven Osworld 1
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production……production……
1. Production facility is designed to meet the GMPrequirement.Production facility is designed to meet the GMPrequirement.
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 environmentWhole production facility is provided with controlled environment
4. Technical area is underventilated systemTechnical area is underventilated system
5. Pharma area meets the requirement of ISO Class 8Pharma area meets the requirement of ISO Class 8
6. Separate personnel entry and material entry are provided forthe PharmaSeparate personnel entry and material entry are provided forthe Pharma
AreaArea
7. Air curtains are provided at all entry point to the production area fromAir curtains are provided at all entry point to the production area from
open environmentopen environment
8. All the waste water outlet in the Pharma area are provided withAll the waste water outlet in the Pharma area are provided with
sanitary drainssanitary 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 MSGLR
3 Reactor 3000 L 3 SS-316
4 Reactor 3000 L 2 MSGLR
5 Reactor 2000 L 1 SS-316
6 Reactor 2000 L 3 MSGLR
7 Reactor 630 L 1 MSGLR
8 Centrifuge 48” / 36” 1 / 2 SS-316
9 NutcheFilter 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 / MSGLR
13 Sifter 36 “ 2 SS-316
14 Multimill - 2 SS-316
15 Octagonal Blender 500 L 1 SS-316
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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 Pneumatic
2 Chilled water (5-10O
C) 135 TR 3 Daikin
3 Chilled Brine-15 O
C 59 TR 1 Reynolds
4 Cooling Tower 500 TR 1 Perfect
5 Cooling Tower 350 TR 2 Perfect
6 Boiler 600 Kg / Hr 4 Thermax
7 Thermic Fluid Heater 2 L K Cal / Hr 1 Energy Machine
8 Hot Water Generator 4 L K Cal / Hr 1 Thermax
9 Vacuum Pump 50 M3
/ Hr to
150 M3
/ Hr
9 Thoshniwal
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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.Mastervalidation plan and its execution.
8.Vendordevelopment /contract laboratory development.
Quality assurancE ……Quality assurancE ……
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aHu systEm ……aHu systEm ……
HVAC system isprovided in thefollowing areaHVAC system isprovided in thefollowing area
-Clean roomsin Manufacturing areaClean roomsin Manufacturing area
-Microbiology LabMicrobiology Lab
-Sampling and Dispensing room in theware-houseSampling and Dispensing room in theware-house
-Filters10, 5 and 0.3 micron.Filters10, 5 and 0.3 micron.
-Technical areaisprovided with 20, 10 and 5 micron filters.Technical areaisprovided with 20, 10 and 5 micron filters.
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WatEr systEm ……WatEr systEm ……
• Raw water isobtained from theborewell.Raw water isobtained from theborewell.
• ThePotablewater generation system consistsof under ground tank, wherethewater isThePotablewater generation system consistsof under ground tank, wherethewater 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 ofThe water from tank is passed through Multigrade filter and thereafter with dosing of
sodium meta bisulphite the water is passed through Duplex softeners. (Free chlorinesodium meta bisulphite the water is passed through Duplex softeners. (Free chlorine
level in soft water ismaintained between 1 to 2 ppm).level in soft water ismaintained between 1 to 2 ppm).
• Soft water ispumped through to ultrafiltration module, then through UV chamber andSoft water ispumped through to ultrafiltration module, then through UV chamber and
then collected in ultrafiltered storagetank.then collected in ultrafiltered storagetank.
• Ultra filtered water is then pumped with dosing of antiscalant solution, sodiumUltra filtered water is then pumped with dosing of antiscalant solution, sodium
hydroxide solution and sodium meta bisulphite (free chlorine level will be maintainedhydroxide solution and sodium meta bisulphite (free chlorine level will be maintained
at zero ppm), Passes through RO membrane and the permeate water (Potable water) isat zero ppm), Passes through RO membrane and the permeate water (Potable water) is
collected in potablewater storagetankcollected in potablewater storagetank
• TheRO generation capacity is6000L per hourTheRO generation capacity is6000L per hour
39. WatEr systEm ……WatEr systEm ……
39
• Potable water generated is pumped through 5 micron filter, then through ROPotable water generated is pumped through 5 micron filter, then through RO
membraneand EDI unitmembraneand EDI unit
• Thepermeatewater from EDI isthePurified water, which isstored in SS316L tank.Thepermeatewater from EDI isthePurified water, which isstored in SS316L tank.
• From storage tank, purified water is passed through UV chamber and circulated inFrom storage tank, purified water is passed through UV chamber and circulated in
loop covering respectiveuser pointsloop covering respectiveuser points
• The return line before tank passes through online conductivity instrument, if theThe 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 isconductivity of the return line water is not within the specified limits, the water is
dumped through thedump valvedumped through thedump valve
• Thegeneration capacity of purified water is1000L per hour.Thegeneration capacity of purified water is1000L 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 pumpsFire 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 detectorsThe 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 moreIn addition to the above appropriate fire extinguishers will be installed in more
than 40 locationsthan 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 theAppropriate PPEs will be made available in the PPE boxes fitted in the
required locationsrequired locations
6. All the employees trained as per the emergency preparedness plan asAll the employees trained as per the emergency preparedness plan as
approved by the Directorof Factoriesapproved by the Directorof Factories
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HEaltH ……HEaltH ……
1. Pre employment health check up and periodic health checkPre employment health check up and periodic health check
will be carried out and health record will be maintainedwill 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 willOccupational Health Centre with all the required facility will
be operationalbe operational
3. An ambulance with all the required facility and medicines willAn ambulance with all the required facility and medicines will
be available in the factory premisesbe available in the factory premises
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EnvironmEnt ……EnvironmEnt ……
1. The waste water generated from the manufacturing activities areThe waste water generated from the manufacturing activities are
segregated into lean waste stream and concentrated waste stream atsegregated 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 byThe lean waste generated is treated and the water is recovered by
passing through Reverse Osmosis system and reused in the coolingpassing through Reverse Osmosis system and reused in the cooling
towerstowers
3. The concentrated waste is sent to the common effluent treatmentThe 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 commonThe hazardous waste generated is incinerated in the common
incineratorapproved by KSPCBincineratorapproved by KSPCB
5. Rain water harvesting facilities are installed as meeting the statutoryRain water harvesting facilities are installed as meeting the statutory
requirementrequirement
6. All the process equipment are connected to the scrubbersAll the process equipment are connected to the scrubbers
