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
Avance Biosciences™ provides biological testing services to support regulatory submission for clients around the world. These services are conducted under the requirements of Good Laboratory Practices and Current Good Manufacturing Practices as promulgated by the U.S. Food and Drug Administration 21 CFR Part 58 and 21 CFR Part 210 and 211, as well as Good Manufacturing Practice according to ICH Q7, where applicable to the laboratory services provided.
Avance Biosciences™ also provides regulatory submission level genomic services in compliance with Good Laboratory Practice Standards required by US Environmental Protection Agency 40 CFR Part 160.
Only approved SOPs/controlled documents are followed during the course of a study.
During a study, at least one in-process or laboratory inspection will be conducted. The study file, data, and final report will be audited by our Quality Assurance Unit prior to issuance of the final report. A Quality Assurance statement will be issued with the final report
Our industry-leading quality system is designed and maintained to support drug and device research and development, GLP pre-clinical trials, cGMP biomanufacturing, and clinical trials.
We welcome current and potential clients to conduct on-site quality and technical audits. Clients may contact our Quality Unit by phone (1.877.909.5210) or by Email (quality@avancebio.com) to schedule a visit.
All services can be provided at either research grade or in compliance with Good Laboratory Practice (GLP) and current Good Manufacturing Practice (GMP) promulgated by the US FDA, OECD, European Commission (EC), Japanese, and other international regulatory agencies.
CGMP (Current Good Manufacturing Practices) are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of pharmaceutical products, and medical devices.
GLP (Good Laboratory Practice) ensures scientific data integrity is being protected at the research level and is applicable for experimental or non-clinical studies conducted for the assessment of the safety or efficacy.
Any of our services are also available at research level with a reduced cost. Research level testing is completed without quality assurance oversight and is not appropriate for submission to regulatory agencies.
When you partner with Avance Biosciences™, you gain a CRO partner that is creative, collaborative and dedicated to sound science with a focus on the regulatory requirements our partners require. Contact our technical staff to discuss how we can support you in your project!
