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BioPharma Services >> Bioanalysis >> Quality

INCREASE YOUR STATISTICAL POWER WITH QUALITY RESULTS

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Eurofins Bioanalytical Services offers integrated solutions designed to ensure the highest quality data achievable by providing accountability and traceability while emphasizing a total quality management process.

Quality Standards

Eurofins Bioanalytical Services has an independent Quality Assurance team, and the quality systems are based on 21 CFR Parts 11 & 58. The quality system includes internal audits, an electronic documentation and training system, deviation and CAPA programs, and Standard Operating Procedures. The USA lab is CLIA certified, and the UK lab is GLP and GCP accredited.

Good Laboratory Practices (GLP)        

    • US FDA Title 21 CFR Part 58 Good Laboratory Practices for Nonclinical Laboratory Studies
    • US FDA Title 21 CFR Part 320 Bioavailability and Bioequivalence Requirements
    • US FDA Title 42 CFR Part 493 Laboratory Requirements
    • OECD General Principles of Good Laboratory Practice
    • Oxford location has been inspected and accredited by the UK MHRA for both GLP and GCP
    • US FDA has inspected both Oxford and St Charles locations for both GLP and GCP

Good Clinical Practices (GCP)

    • US FDA Title 21 Part 50 Protection of Human Subjects
    • ICH Guidelines for Good Clinical Practice
    • ‘Statutory Instrument No. 2004/1031. The Medicines for Human Use (Clinical Trials) 2004 as amended’

Good Manufacturing Practices (GMP)

    • US FDA Title 21 CFR Part 210 Manufacturing, Processing, Packaging or Holding
    • US FDA Title 21 CFR Part 211 Finished Pharmaceuticals
    • Focusing  on quality and potency of highly specialized large molecule support
    • Our GMP-compliant solutions support the analytical stability and release of biologic products
    • On-site efficiencies providing clients with performance that is critical to IND, and early phase clinical studies
    • Expertise to support full range of requirements for cell-based assays

Electronic Records

FDA 21CFR Part 11 “Electronic Records; Electronic Signatures; Final Rule”