Roles&Responsibilities-;
• To maintain copies of all approved study plans and their amendments (if any) and Standard Operating Procedures (SOPs) in use in test facility
• To have access to an up to date copy of Master Schedule
• To review the study plan/amendment/SOPs as per compliance with principles of GLP. This review is to be documented
• Review of Deviations and Change controls in the test facility
• Routine review of logbooks, environmental monitoring and power backup system.
• To conduct inspections to verify that all studies are conducted according to GLP principles. This inspection also should verify that; SOPs and study plan are available with study personnel.
• Preparation of schedule for test facility audit.
• Three types of inspection are to be conducted viz.
• Review of final report to confirm that methods, procedures and observations are accurately and completely described and the reported results reflect completely the raw data of the study. Accordingly, a statement is to be issued and to be delivered along with study report.
• i) study based, ii) facility based and iii) process based. Records of all inspections are to be retained and archived.