GMP Analytical Testing

Services offered

The BPT analytical team is competent in handling various chromatographic and spectroscopic techniques.
Current services offered by Eurofins BPT, India are for Drug Substance, Drug Product, Intermediates and Excipients

• Elemental impurities evaluation as per ICH Q3D
• Genotoxic impurities evaluation as per ICH M7
• Extractable & Leachable studies for packaging, container closure system and medical devices
• Residual Solvents testing at trace level using GC Head Space technology with MS
• Nitrosamine impurities evaluation in drug substance and drug product per 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
• Photostability studies
• ICH and VICH stability studies
• Microbiology testing

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
• pXRD
• Ion Chromatography
• UV and FTIR spectroscopy
• Dissolution tester Type I and Type II
• Walk-In Stability chambers

Quality & Compliance

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 world class quality system and to continually seek improvements in its effectiveness .
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
• Life Cycle Management of Equipment/Instruments
• Instrument Qualifications/ Calibrations
• 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 11compliant Software
• Electronic data backup and restoration
• Secure, virus-free system
• Archival Management

Any Time Audit Readiness
We are audit ready all the time through For Virtual or Onsite 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