info@advinus.com

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 Finished Product Testing, Eurofins BioPharma Product Testing’s 38 facilities 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. 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.

GMP ANALYTICAL TESTING

FDA

USFDA Inspected Laboratory

cGMP

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
  • Nitrosamine impurities evaluation in drug substance and drug product
  • HPLC/GC method development, feasibility, optimization, verification, validation and transfer
  • Release Testing
    • DS/DP analysis as per monograph
    • Raw material analysis

Extension of Services from Q1 2022

  • Extractable & Leachable
  • Stability Storage/Studies
  • Packing material analysis
  • Gel Permeation Chromatography
  • Residual solvents evaluation
  • Forced degradation studies

Equipment

  • High Performance Liquid Chromatography (HPLC) equipped with diode array, variable wavelength, and refractive index detector
  • Gas Chromatography
  • Liquid chromatographic-mass spectrometry (LC-MS/MS)
  • Inductively coupled plasma-mass-spectrometry (ICP-MS)
  • Gas Chromatography Mass spectrometry (GC-MS/MS)

Quality Training Experience

We are audit ready on all days through our e-Audit portals where you can verify SOPs, protocols, reports, quality data and policies from your desktop. We are equally pleased to welcome you in our facility at predetermined schedules.

Quality System

  • Organogram & Job Responsibilities
  • List of SOPs and individual SOPs
  • List of Equipment/Instruments
  • Instrument Qualifications
  • Document Control and issuance
  • Change management
  • Handling of deviations, CAPA and investigations
  • Individual Deviations and OOS
  • Validation Master Plan
  • Sample testing and release
  • Computerized system validation, electronic data control and backup
  • Waste handling and material destruction
  • Calibration and preventive maintenance program
  • Training and analyst qualification program
  • Analytical method validation/transfers
  • Laboratory OOS / OOT

Laboratory Data
The following data are captured online meeting 21CFR Part 11:

  • Sample receipt, storage, and tracking
  • Sample preparation
  • Analysis raw data
  • Reports
  • Analytical methods
  • Instrument logs
  • Temperature logs
  • Room logs
  • Reference standard inventory and use log
  • Chemicals inventory
  • HPLC column inventory log and use log

Any Time Audit
We are audit ready all the time through our e-Audit portals where you can review your samples journey in EBPTL at various stages. eAudit enables you to cut your travel consequently saving your valuable time and cost of audit. 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!