Quality Assurance Unit is to ensure that studies are performed in accordance with Good Laboratory Practice (GLP)-Good Clinical Practices (GCP) regulations and in house procedures.
Responsible for document control of study protocols, analysis plans, SOPs & policies; and ensures updated versions of these controlled documents are effective and in place or accessible to relevant staff.
Makes audits which include:
- Study source documentation, procedures, and reports; and provides regulatory advice and support to the operational staff.
- Facility & system, to check adequacy & eligibility of resources and proper utilization of provisions.