Quality Compliance
Eurofins Advinus adopts globally recognized quality systems
Good Laboratory Practice (GLP) for non-clinical studies – accredited since 1992
Current Good Manufacturing Practice (cGMP) for early clinical supplies
Quality Assurance Unit
Eurofins Advinus Quality Assurance unit (QAU) consists of highly qualified and experienced professionals. The quality assurance systems and processes include review of documents, conduct of facility-based, process-based and study-based inspections to maintain high standards of quality and monitor studies for compliance to global regulatory requirements.
The QAU reports directly to the Management to ensure that it works independent of the study teams.
QA Functions
- QAU is involved in monitoring studies and projects under GLP and cGMP areas
- Assure that studies are performed in compliance with the principles of GLP and materials for early clinical supplies are generated to comply with cGMP requirements
- Inspects and audits facility and processes and assures that studies or projects are conducted in compliance with SOPs and protocols
- Evaluates and qualifies test sites, contract test facilities and/or contract research organizations for outsourcing any study, study phase, project and/or project phase
- All SOPs, protocols/study plans, draft and final reports are reviewed by QAU and QA statements are issued
- QAU is responsible for facilitating inspections/audits by monitoring and regulatory authorities including site visit for auditing by sponsors.
