Itl Slide.ppt LAB TESTING DRUG AND PHARMAA PROFILE

ITL

1. ITL Labs Pvt LtdITL Labs Pvt Ltd
ITL Labs Pvt. Ltd.
25, Gokuldas Compound, Industrial, Opp.Kalyan
Mill,Indore 452011 (M.P.)
www.itllabs.net email: [email protected]

2. INTRODUCTIONINTRODUCTION
ITL Labs Pvt. Ltd. is a Multi Program
Laboratory with adequate technical staff.
This group allows access to a wide variety of
expertise in many scientific fields.

3. Vision……Vision……
ITL‘ s vision is to be the clear
leader and innovator in
verification and testing,
building upon our brand,
integrity, unique network and
the excellence of our people

4. Mission……Mission……
ITL‘ s core mission is to
deliver science and
technology to meet key
needs of the industry

5. Services……Services……
Competitive Pricing without compromising quality Competitive Pricing without compromising quality
24 Hour Priority Turn around available for some analyses24 Hour Priority Turn around available for some analyses
Computer & Fax Communication & E-mail for Faster Computer & Fax Communication & E-mail for Faster
Communication Communication
Free sample containers with Proper Preservatives!Free sample containers with Proper Preservatives!
Free Courier Service!Free Courier Service!
Free Consultation and Quotes! Free Consultation and Quotes!

6. Accreditation / Affiliations & Accreditation / Affiliations &
RecognitionsRecognitions

NABL Accredited NABL Accredited

ISO 9001 Certified. ISO 9001 Certified.

Ministry of Health & Family Welfare, Drugs Control Department Ministry of Health & Family Welfare, Drugs Control Department
(Government of NCT of Delhi)(Government of NCT of Delhi)

Ministry of Environment and Forests Approved Ministry of Environment and Forests Approved

Department of Indian System of Medicine & Homeopathy (AYUSH)Department of Indian System of Medicine & Homeopathy (AYUSH)

United Nations Office for Project Services United Nations Office for Project Services

Madhya Pradesh Laghu Udyog Nigam Limited Madhya Pradesh Laghu Udyog Nigam Limited

Indian Space Research Organization Indian Space Research Organization

Directorate General Supplies and DisposalDirectorate General Supplies and Disposal

7. OUR THRUST AREASOUR THRUST AREAS

Environmental MonitoringEnvironmental Monitoring

Project ConsultancyProject Consultancy

Inspection & Evaluation ServicesInspection & Evaluation Services

Analytical ServicesAnalytical Services

Validation Services Validation Services

Stability TestingStability Testing

Calibration ServicesCalibration Services

8. Environmental Monitoring…..Environmental Monitoring…..

Hero Honda Motors Ltd., ManesarHero Honda Motors Ltd., Manesar

Rico Auto Industries Ltd., GurgaonRico Auto Industries Ltd., Gurgaon

Omaxe Auto Industries Ltd., Manesar Omaxe Auto Industries Ltd., Manesar

Climate Systems Ltd., BhiwadiClimate Systems Ltd., Bhiwadi

Morepen Laboratories Ltd., ParwanooMorepen Laboratories Ltd., Parwanoo

Jindal Industries Ltd., HisarJindal Industries Ltd., Hisar

Hindustan Glass Industries, Allahabad Hindustan Glass Industries, Allahabad

Somany Pilkington Ltd., BahadurgarhSomany Pilkington Ltd., Bahadurgarh
The company has come to be known as a force to reckon with in the field of
environmental impact assessment. The environmental monitoring division of
the Company has carried out over fifty EIA Studies. List of major clients
includes:

9. Project Consultancy…..Project Consultancy…..

To provide customised solutions to analytical problems.To provide customised solutions to analytical problems.

To develop and design Effluent Treatment Plant / Sewage Treatment Plant.To develop and design Effluent Treatment Plant / Sewage Treatment Plant.

To assess, design, develop and implement Quality Management System.To assess, design, develop and implement Quality Management System.

To assess, design, develop and implement Environmental Management To assess, design, develop and implement Environmental Management
SystemSystem

To carry out expiration dating studies.To carry out expiration dating studies.

To develop and validate new product formulations.To develop and validate new product formulations.

To supply and set up Laboratories (Analytical, Environmental, Pathological, To supply and set up Laboratories (Analytical, Environmental, Pathological,
Field monitoring) on turnkey basis. Field monitoring) on turnkey basis.

To carry out feasibility study and preliminary designing of water supply To carry out feasibility study and preliminary designing of water supply
facilities.facilities.
Main objectives of the division are,
List of clients:
Cipla Ltd, Ranbaxy Laboratories Ltd., Torrent Laboratories Ltd, Hindustan Petro
Chemicals Ltd., Indian Oil Corporation (Panipat Refinery)

11. Inspection & Evaluation Services…..Inspection & Evaluation Services…..

This division works as a third party inspection & evaluation unit in the field of materials, This division works as a third party inspection & evaluation unit in the field of materials,
drugs & pharmaceuticals, medical devices, and exports.drugs & pharmaceuticals, medical devices, and exports.

Inspections are carried out through a team of dedicated professionals in the field Inspections are carried out through a team of dedicated professionals in the field
mentioned above. mentioned above.

Primary activities include –Primary activities include –

Inspection of materials as per given international standards.Inspection of materials as per given international standards.

Representative sampling of goods offered.Representative sampling of goods offered.

Analysis and subsequent submission of evaluation certificate based on site and in house Analysis and subsequent submission of evaluation certificate based on site and in house
data.data.
Clientele includes:
MB Enterprises, Panacea Biotech Limited, Udaypur Minerals Limited Hema
Engineering Co. ltd, SGS Tekniks Pvt. Ltd, Pepsico Holdings Pvt. Ltd, Hindustan
Medical Devices, Serenity Trading L.L.C.

12. Analytical Services…..Analytical Services…..

Drugs and PharmaceuticalsDrugs and Pharmaceuticals

Water and waste water (Effluent)Water and waste water (Effluent)

Air, Soils, Noise MetalsAir, Soils, Noise Metals

Food and Farm Products, Vegetable oils and SoapsFood and Farm Products, Vegetable oils and Soaps

CosmeticsCosmetics

Chemicals, Minerals, Fertilizers.Chemicals, Minerals, Fertilizers.

PesticidesPesticides

Rubber and Plastics.Rubber and Plastics.
The Analytical Science Division offers services in the field of testing
materials and products through highly advanced techniques and with the
help of sophisticated instruments. Over 400 organizations including Industry
and Government Agencies are patronizing ITL. All activities of ITL are
ISO /IEC 17025: 2005 accredited.

13. Analytical Services…..Analytical Services…..
Drugs and Pharmaceuticals
Company is catering to the needs of National as well as International Clients for Drugs
and Pharmaceuticals testing. The testing is carried out in line with National and
International Standards (Indian Pharmacopoeia, British Pharmacopoeia, United States
Pharmacopoeia, European Pharmacopoeia, Japanese Pharmacopoeia, International
Organization for Standards). Method validation, expiration dating, new product
development studies are als undertaken by this division.
Water and waste water (Effluent)
All type of waters viz., Drinking, Effluent, Construction, Boiler, De-mineralized, Coolant,
Laundry, Ground, Packaged/ bottled, and Process water are analyzed as per National
(Bureau of Indian Standards, Environment Protection Act) and International Standards
(American Public Health Association, United State Environment Protection Agency,
Water Environment Federation, American Water Works Association, Federation of
Sewage and Industrial Waste Association).

14. Air, Soils, Noise
This division has capability to collect and analyze Ambient air quality, Stack emissions,
Flue gases, Soils, Noise as per National (BIS) and International Standards (European
Norms, Indoor Air Quality Standards, International Organization for Standards and
OECD Norms).
Provisions exist for continuous on site monitoring of air and soil quality. A team of
dedicated trained samplers and scientists works round the clock to produce verifiable
authentic data.
Analytical Services…..Analytical Services…..
Metals
Complete chemical analysis and studies including physical test as per
National (BIS) and International Standards (American Society for Testing of
Materials)

15. Analytical Services…..Analytical Services…..
Food and Farm Products, Vegetable oils and Soaps

Proteins, fats, carbohydrates, minerals, preservatives, toxic metals and Proteins, fats, carbohydrates, minerals, preservatives, toxic metals and
Other constituents.Other constituents.

Bacteriological examination.Bacteriological examination.

Chemical and physical properties.Chemical and physical properties.

Migration tests in plastic and packaging materials.Migration tests in plastic and packaging materials.

Test on milk powder including differential analysis of Amino acids.Test on milk powder including differential analysis of Amino acids.

Soaps as per relevant specifications Soaps as per relevant specifications
Cosmetics

Chemical analysis of CosmeticsChemical analysis of Cosmetics

Stability study and shelf life studies of formulations Stability study and shelf life studies of formulations

Preservative effectiveness studies Preservative effectiveness studies

16. Analytical Services…..Analytical Services…..
Chemicals, Minerals, Fertilizers.

Complete chemical and physical analysis as per National StandardsComplete chemical and physical analysis as per National Standards
Pesticides

Capabilities exist to analyze Carbamates, Organochlorine, Capabilities exist to analyze Carbamates, Organochlorine,
Organophosphorus, Acidic herbicides and other pesticides as per USEPA Organophosphorus, Acidic herbicides and other pesticides as per USEPA
Standards using sophisticated analytical instruments Standards using sophisticated analytical instruments
Rubber and Plastics.

The company has entered in to an agreement with U.S based consulting firm The company has entered in to an agreement with U.S based consulting firm
A.T. Kearney Limited for their requirement of material testing in India. A.T. Kearney Limited for their requirement of material testing in India.
Rubbers and Plastics including biodegradable polymers are tested fulfilling all the
steps and requirements of ASTM Standards.

17. Validation Services…..Validation Services…..

Discuss your requirements Discuss your requirements

Suggest the most appropriate and cost effective testing protocolSuggest the most appropriate and cost effective testing protocol

Oversee the testing programme Oversee the testing programme

Prepare the final report Prepare the final report
Method tailored to best suit products and the monitoring of their performance can be
developed, validated and reported under ICH Guidelines, with Study Management to GLP
requirements. An experienced member of staff, appointed as the Study Director will:

Full method details Full method details

Results obtainedResults obtained

Graphical representations of data Graphical representations of data

Calculation protocols Calculation protocols

Validation data, including specificity, applicable range, accuracy, precision, Validation data, including specificity, applicable range, accuracy, precision,
limits of detection limits of detection
The final report, fully explained to the client by the Study Director, will include:

18. Stability Testing…..Stability Testing…..

Various criteria for product stabilityVarious criteria for product stability

Chemical, physical and microbiological aspects of stability studies Chemical, physical and microbiological aspects of stability studies

Selection of appropriate, validation monitoring methods Selection of appropriate, validation monitoring methods

Difficulties that arise with certain types of products and the limitations of Difficulties that arise with certain types of products and the limitations of
certain test procedures certain test procedures

Interpretation of test results Interpretation of test results

Documentation of test results Documentation of test results

Documentation of testing protocols Documentation of testing protocols

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