Our quality system is well designed and maintained to meet the most stringent requirements from regulatory authorities worldwide. This system is well tested in many on-site client quality audits and is highly accommodated by our customers.
The Avance Biosciences team is committed to strict adherence to CGMP and GLP regulations and guidelines enacted by the US, European, Japanese, and other international regulatory agencies. The Avance Biosciences Houston, Texas facility provides regulated and research grade contract molecular biology testing services to pharmaceutical, biotechnology, and other institutions. Our established quality system is based on the requirements of Good Laboratory Practices, current Good Manufacturing Practices, and Quality System Regulation as promulgated by the U.S. Food and Drug Administration 21 CFR Part 58, 21 CFR Parts 210, 211, and 820 respectively, and by European, Japan, and other international regulatory agencies. In addition, Avance Biosciences provides genomic services supporting regulatory submission to the US Environmental Protection Agency per 40 CFR Part 160.
Avance Biosciences’ compliance with these regulations is defined in the Avance Biosciences Quality Manual, Quality System Master Plan, and Quality System (QS) Standard Operating Procedures (SOPs).
CGMP compliance per FDA 21 CFR Part 210/211
GLP compliance per FDA 21 CFR Part 58
Compliance per FDA 21 CFR Part 11 for electronic records
Independent quality unit assuring regulatory compliance
Documented change control and review program
Regularly equipment maintenance and calibrations
Routine internal quality audits and in-process audits
Facility frequently audited by clients
Incident report, OOS, and CAPA program
Vendor assessment program and raw material quarantine and release program
Systematic approach in preventing cross-contamination from environment, reagents, and supplies
Rigorous sample tracking and handling procedures to prevent mistakes and cross-contamination
Methods/assays validated per ICH guidelines
Optimized laboratory design and rigorous cross-contamination prevention measures
Ongoing employee training and proficiency test program
Complete documentation of laboratory procedures
Project archive and storage procedures
Transparent process flow and frequent progress updates