Eurofins BioPharma Product Testing (BPT) India operates a cGMP-compliant testing facility in Bengaluru (with Establishment Inspection Report from US Food & Drug Administration) delivering end-to-end analytical testing services for the pharmaceutical and medical device industry.

Our state-of-the-art testing facility specialises in:

• Analytical method development and validation including nitrosamine impurity testing
• Extractable & leachable testing
• Microbiology testing
• Stability studies

Your trusted partner for cGMP-compliant BioPharma Product Testing solutions

Eurofins BioPharma Product Testing is a global leader in providing high-quality GMP testing solutions to pharmaceutical, biopharmaceutical and medical device companies worldwide. With over 45 facilities across more than 20 countries, we offer the most comprehensive scope of harmonised GMP testing services, enabling seamless regulatory acceptance and ensuring reliable results from raw materials to finished products.

Comprehensive analytical testing services

Our expert analytical team is proficient in chromatographic and spectroscopic techniques, offering testing services for drug substances, drug products, intermediates, and excipients:

• HPLC/GC method development & validation
• Nitrosamine impurity testing (as per EU and USP regulations)
• Elemental impurity evaluation (as per ICH Q3D)
• Genotoxic impurity evaluation (as per ICH M7)
• Extractable & leachable studies (for packaging, container closure systems, and medical devices)
• Residual solvent testing (using GC Headspace with MS for trace-level detection)
• Forced degradation studies
• Release testing (Drug substance, drug product, raw material & excipient analysis as per pharmacopeial monograph and customer specific in-house methods.)
• Dissolution profile studies
• Packaging material analysis
• Microbiology testing
• Stability testing and storage, photostability studies
• ICH and VICH stability studies
  
  

Advanced testing capabilities

Our cutting-edge laboratories are equipped with:

• High-performance liquid chromatography (HPLC) (diode array, variable wavelength, and refractive index detector)
• Gas chromatography with headspace (GC-HS)
• Liquid chromatography-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 for material characterisation
• Ion chromatography
• UV and FTIR spectroscopy
• Dissolution apparatus (Type I & Type II)
• Walk-in stability chambers

Quality & compliance: ensuring excellence

At Eurofins BPT India, we adhere to stringent regulatory requirements and a robust four-layered Quality Management System:

• Quality Manual
• Management System Procedures
• Standard Operating Procedures (SOPs), Policies, Methods, and Standards
• Documentation & Format Control

Our comprehensive quality assurance measures include:

• Training and Analyst Qualification Programs
• Deviation and Out-of-Specification (OOS) Management
• Corrective and Preventive Actions (CAPA) Implementation
• Change Control Management
• Life Cycle Management of Equipment & Instruments
• Validation Master Plans
• Computerized System Validation and Electronic Data Control (21 CFR Part 11 compliance)
• Data Integrity & Archival Management

We are frequently audited by clients, ensuring that our site maintains robust quality systems aligned with major global regulatory guidelines such as USFDA, MHRA, and EU standards, in addition to having our own internal controls that meet compliance requirements.