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 follows all GLP and GCP guidelines.
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
- US FDA has been inspected 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’
Electronic Records
FDA 21CFR Part 11 “Electronic Records; Electronic Signatures; Final Rule”