Quote from VigiServe Admin on November 24, 2020, 2:37 PM

POSTMARKETING ADVERSE DRUG EXPERIENCE (PADE) INSPECTIONS COMPLIANCE PROGRAM FOR HUMAN
DRUG AND THERAPEUTIC BIOLOGICAL PRODUCTS

 

Risk-based Site Selection

1. Inspection History - Never inspected, inspection findings from other program areas (e.g. GMP inspection), triggered from previous PADE inspection response

2. Product Portfolio - New products, recalls/ patient exposure, Issues in submission (ICSR/PADER)

3. Firm Information - Corporate changes, internal FDA information, complaints, info from other authorities

 

PADE Inspection Coverage

Quality Management System:

• Written procedures

• Root cause analyses and corrective actions for deviations

• Training documents

ICSRs

• ADEs from all sources

• Confirmation of electronic submissions

• Late, missing, incomplete, or inaccurate 15-day reports

• Follow-up processes

Periodic Reports

• Late or missing periodic reports

• Late or missing annual reports

• Waivers

Others

• Product list (approval date, status, etc.)

• Organization, roles and responsibilities

Agreements

• Safety Contracts - with Vendors

• Safety Data Exchange Agreements