Quality assurance and regulatory aspects
All studies are performed together with CCBR under the quality assurance protocols implemented.
10 - 15 audits and inspections are performed per year from:
- FDA
- EMEA
- Local Regulatory Authorities
- Sponsor’s
- CRO’s
Last EMEA inspection was in May 2008 with no significant findings
The quality assurance team conducts internal audits at regular intervals:
- Compliance with SOPs, Good Clinical Practices and ICH guidelines
- Investigational products are properly stored and maintained according to SOP
- Applicable laboratory procedures are properly documented and available including sample administration, equipment calibration logs, and service and maintenance records
- Applicable clinic procedures are properly documented and available including equipment calibration logs and services and maintenance records
- Complete training records, job descriptions / curricula vitae (CV) for study personnel
- Data consistencies between electronic and source documentation
- Audits are conducted according to internal audit plan and SOPs