Dedication to Quality

Quality2019-03-29T19:07:42+00:00

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.

Quality

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.

When you partner with Avance Biosciences, we give you undivided attention, share our experience and knowledge, and respond to your needs in a timely manner. Contact our technical staff to discuss how we can support you in your project!

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Dedication to Quality

Dedication To Quality

The Avance Biosciences team is committed to strict adherence to cGMP and GLP regulations enacted by the US, European, Japanese, and other international regulatory agencies.

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Extensive Experience

Extensive Experience

Our team has extensive knowledge and experience working with scientists, QA/QC professionals, and project managers from over 100 pharmaceutical and biotechnology companies and organizations throughout the world.

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Open Communication

Open Communication

Transparency and integrity are two of our core values. Our well-trained, friendly, and professional study directors and project managers strive to complete your projects on-time with open communication channels and to your specifications.

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Cutting Edge Science

Open Communication

Avance Biosciences’ cGMP/GLP compliant genomic and microbial assays make use of the advanced technologies including real-time PCR, digital PCR, Sanger sequencing, next generation sequencing, and more.

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