REGULATORY COMPLIANCE SUPPORT

EUGMP

Legislative and Regulatory Requirements and Scope

• Empowering legislation
• Conflict of interest

Regulatory Directives and Policies

• Procedures for designating inspectors
• Training certification policies/guidelines
• Alert/crisis management policies/procedures/guidelines
• Organizational structure

GMP Standards

• Details/ scope of GMP
• Process validation

Inspection Resources

• Staffing: Initial qualification
• Number of inspectors
• Training programme
• QA mechanism to assure effectiveness of training programme

Inspection Procedures

• Inspection strategy
• Pre-inspection preparation
• Format and content of inspection reports
• Inspection methodology
• SOP for conducting inspections
• Inspection procedures – Post-inspection activities
• Inspection procedures – Storage of inspection data

Inspection Performance Standard

• Performance standards

Enforcement Powers and Procedures

• Provision for written notice of violations
• Non-compliance management
• Appeal mechanism
• Other measures

Alert and Crisis Systems

• Alert mechanisms
• Crisis management mechanisms
• Alert performance standards

Analytical Capability

• Access to laboratories
• SOPs for analytical support
• Validation of analytical methods

Surveillance Programme

• Sampling and audit procedure
• Recall monitoring
• Consumer complaint system
• Adverse reaction reporting system/ procedures
• Medicinal product defect reporting system/ procedures

Quality Management System

• Quality management system

Some Countries Included in EUGMP Certification