Quality Assurance
- A designated Quality Assurance Programme exists at Aragen BioSafety Solutions, following the OECD Guidance document.
- Our independent Quality Assurance Unit consists of a team of ten experts from diverse fields, including Toxicology, Chemistry, DMPK, Biotechnology, and Environmental Science.
- QA team members have prior technical experience and extensive knowledge of the subjects they audit.
- QA auditors undergo exhaustive GLP training conducted by regulatory authorities, external trainers, and in-house experts.
Functions of the Quality Assurance Unit (QAU)
Study-Based Inspections
- Review of draft and final study plans.
- Inspection of critical in-life phases.
- Evaluation of draft and final reports.
Facility-Based Inspections
- Regular audits of processes and facilities.
- Master schedule audits.
- SOP/Format audits.
- Specimen audits before archiving.
- Audit of contract testing laboratories.
Additional QAU Responsibilities
- Reporting inspection findings to Test Facility Management and Study Directors or concerned personnel.
- Providing GLP regulations training and refresher courses to staff, including new entrants to the QAU.
- Participating in meetings with sponsors, regulatory authorities, and GLP monitoring authorities.
