Eurofins BioPharma Product Testing holds a proven track record of providing quality GMP testing services for the largest pharmaceutical and biopharmaceutical companies in the world, Eurofins BioPharma Product Testing is a global leader in bio/pharma laboratory services providing comprehensive, innovative, and timely solutions. From Starting Materials through stability testing if any other facility among 38 mentioned have the capability located in 19 countries deliver the world’s most comprehensive scope of harmonized GMP testing services and seamless regulatory acceptance
Eurofins Advinus GMP Analytical Testing, in affiliation with Eurofins BioPharma Product Testing, India, a cGMP-compliant and US-FDA inspected facility with NAI (ZERO 483) provides analytical testing and validation services to the pharmaceutical industries. We are NABL accredited (ISO 7025). The facility is operating from a location close to airport at Chennai. With more than 100-man years of cGMP analytical service in leading pharmaceutical companies in India and USA, the GMP Analytical Testing facility was created to share the expertise with pharmaceutical community to support projects from laboratory to the marketplace.
The testing facility provides analytical testing and validation services to the pharmaceutical industries. Services include method development/validation, raw material, intermediate testing, and product release testing.
Services
The analytical team is competent in handling various chromatographic and spectroscopic techniques.
We cater to the pharmaceutical industries through following activities
Current services offered by Eurofins BPT, India for Drug Substance, Drug Product, Intermediates and Excipients
- Elemental impurities evaluation as per ICH Q3D
- Genotoxic impurities evaluation as per ICH M7
- Extractable & Leachable
- Residual Solvents
- Nitrosamine impurities evaluation in drug substance and drug product EU and USP regulation
- HPLC/GC method development, feasibility, verification, validation, and transfer.
- Forced degradation studies
- Release Testing
- Drug Substance /Drug product analysis as per monograph
- Raw material and excipients analysis
- Dissolution Profile studies
- Packing material analysis
- Gel Permeation Chromatography
- Photostability studies
Equipment
- High Performance Liquid Chromatography (HPLC) equipped with diode array, variable wavelength, and refractive index detector
- Gas Chromatography with Headspace using FID Detector
- Liquid chromatographic-mass spectrometry (LC-MS/MS)
- Inductively coupled plasma-mass-spectrometry (ICP-MS)
- Gas Chromatography Mass spectrometry (GC-MS/MS)
- Particle size analyser – Malvern Mastersizer 3000
Quality Training Experience
Eurofins Biopharma Product Testing India PVT LTD believes that meeting compliance obligations is a responsibility essential to its long-term success. Ensure the continued development, implementation, and maintenance of the quality system and to continually seek improvements in the effectiveness of the quality system.
Quality Management system consisting of 4 layers
- Quality Manual
- Management System Procedures
- SOPs, Policy, Methods, Standards
- Formats
Quality System
- Organogram & Job Responsibilities
- Training and analyst qualification program
- Quality Manual
- Handling of deviations
- Handling of Out of Specification Results
- Handling of CAPA
- Change Control management
- List of Equipment/Instruments
- Instrument Qualifications
- Validation Master Plan
- Sample testing and release
- Computerized system validation, electronic data control and backup
Laboratory Data
The following data are captured online meeting 21CFR Part 11:
- Sample receipt, storage, and tracking
- Chemical’s inventory
- Analytical methods
- Sample preparation
- Instrument logs
- Temperature logs
- Reference standard inventory and use log
- HPLC and GC column inventory log and use log
- Analysis raw data
- Reports
- Secure, virus-free system
- 21 CFR Part 11 Software
- electronic data backup and restoration
- Secure, virus-free system
- Archival Management
Any Time Audit
We are audit ready all the time through For Virtual Audit where you can review your samples journey in EBPTL at various stages. Virtual Audit enables you to cut your travel consequently saving your valuable time and cost of audit. We are equally pleased to welcome you in our facility at predetermined schedules. You can have more frequent audits depending on complexity of your project. We will be pleased to assist you in all aspects. You are welcome to visit us in person too!
Journey of Eurofins BPT, India

Details of Validation
Category | Type of Validation | Technique |
---|---|---|
Lidocaine HCl | Nitrosamines Testing | LCMS/MS |
Lidocaine base | Nitrosamines Testing | LCMS/MS |
Meloxicam | Nitrosamines Testing | LCMS/MS |
Melatonin | Nitrosamines Testing | LCMS/MS |
Pentosan polysulfate sodium | Nitrosamines Testing | LCMS/MS |
Paracetamol | Nitrosamines Testing | LCMS/MS |
Glipizide | Nitrosamines Testing | LCMS/MS |
Glibenclamide | Nitrosamines Testing | LCMS/MS |
Furosemide | Nitrosamines Testing | LCMS/MS |
Zileuton | Nitrosamines Testing | LCMS/MS |
Pentoxifylline | Nitrosamines Testing | LCMS/MS |
Sapropterin dihydrochloride | Nitrosamines Testing | LCMS/MS |
Paroxetine Hydrochloride Hemihydrate | Nitrosamines Testing | LCMS/MS |
Diphenhydramine Citrate | Nitrosamines Testing | LCMS/MS |
Methohexital API | Nitrosamines Testing | LCMS/MS |
Prilocaine | Nitrosamines Testing | LCMS/MS |
Prilocaine | Nitrosamines Testing | LCMS/MS |
Granisetron Hydrochloride | Nitrosamines Testing | LCMS/MS |
Granisetron Hydrochloride | Nitrosamines Testing | LCMS/MS |
Diphenhydramine hydrochloride | Nitrosamines Testing | LCMS/MS |
Folic acid Hydrate | Nitrosamines Testing | LCMS/MS |
Diphenhydramine hydrochloride | Nitrosamines Testing | LCMS/MS |
Mefenamic acid | Nitrosamines Testing | LCMS/MS |
Olanzapine | Nitrosamines Testing | LCMS/MS |
Tramadol HCL | Nitrosamines Testing | LCMS/MS |
Nitrofurantoin monohydrate USP | Nitrosamines Testing | LCMS/MS |
Montelukast Sodium | Nitrosamines Testing | LCMS/MS |
Tamsulosin Hydrochloride | Nitrosamines Testing | LCMS/MS |
Midodrine Hydrochloride Tablet 2.5 MG & 5 MG | Nitrosamines Testing | LCMS/MS |
Glycopyrrolate | Nitrosamines Testing | LCMS/MS |
Silodosin | Nitrosamines Testing | LCMS/MS |
Dronedarone HCL | Nitrosamines Testing | LCMS/MS |
RS AMP | Related Substance | HPLC |
Assay of AMP | Assay | HPLC |
Rivaroxaban | Assay | HPLC |
Cimetidine API | Related Substance | HPLC |
Cimetidine Tablet | Related Substance | HPLC |
Terbinafine | Related Substance | HPLC |
Chenodeoxycholic acid | Assay | HPLC |
Chenodeoxycholic acid | Related Substance | HPLC |
7-Keto Lithocholic acid | Assay | HPLC |
7-Keto Lithocholic acid | Related Substance | HPLC |
Ursodeoxycholic acid | Assay | HPLC |
Ursodeoxycholic acid | Related Substance | HPLC |
Terbinafine HCL | Organochlorine Testing | GC-HS |
Tamsulosin Hydrochloride | Nitrosamines Testing | GCMS/MS |
Glycopyrrolate | Nitrosamines Testing | GCMS/MS |
Silodosin | Nitrosamines Testing | GCMS/MS |
Domeperidone | Cd,pb,As,Hg,Co,V,Ni,Mo,Cr,Fe | ICP/MS |
Furosemide | Cd,pb,As,Hg,Co,V,Ni,Mo,Cr,Fe,Sb, Li,Cu | ICP/MS |
Warfarin Sodium clathrate injection | Cd,pb,As,Hg,Co,V,Ni,Mo,Cr,Fe,Sb, Li,Cu | ICP/MS |
Warfarin Sodium clathrate oral injection | Cd,pb,As,Hg,Co,V,Ni,Mo,Cr,Fe,Sb, Li,Cu | ICP/MS |
Lanthanum Carbonate | Lanthanum ICP/MS |