How to Manage Internal GMP (Good Manufacturing Practice) Audits Training Course

Introduction to internal GMP audits

• Overview of Good Manufacturing Practices (GMP) and their importance
• Role of internal audits in ensuring compliance and continuous improvement
• Key components of an internal GMP audit program

The role of internal audits in compliance and risk management

• How internal audits help identify risks and prevent compliance issues
• Aligning audits with regulatory requirements (FDA, EMA, WHO)
• Identifying critical GMP areas to focus on during audits

Planning for internal GMP audits

• Defining audit scope, objectives, and goals
• Risk-based approach to selecting areas for auditing
• Preparing audit checklists and audit tools
• Assigning roles and responsibilities within the audit team

Managing the audit process – best practices

• The key stages of an internal audit (planning, execution, reporting, follow-up)
• Preparing for the audit: document review and information gathering
• How to lead an audit team and maintain objectivity
• Conducting effective interviews and observations

Workshop - risk management practices in internal audit plan preparation

Conducting the internal GMP audit

• Techniques for effective onsite auditing
• Identifying and evaluating non-conformities and compliance gaps
• Assessing facilities, equipment, and manufacturing processes
• Effective ways of interacting with staff and departments during the audit

Documenting audit findings and reporting

• How to document audit findings accurately and clearly
• Best practices for audit reporting: structuring and presenting results
• Ensuring transparency and objectivity in audit reports
• Reporting non-conformities, risks, and recommendations

Corrective and preventive actions (CAPA)

• Identifying root causes of non-conformities
• Developing effective corrective actions and preventive measures
• Working with departments to implement CAPA plans
• Verifying the implementation and effectiveness of CAPA

Post-audit follow-up and continuous improvement

• How to track progress on CAPA implementation
• Maintaining audit records and documentation for future reference
• Using audit results to foster a culture of continuous improvement
• Leveraging audits as a tool for enhancing quality and compliance

Managing challenging audit scenarios

• Handling resistance to audits and managing difficult auditees
• Navigating complex audits in high-risk areas
• How to manage audits in areas with a prior non-compliance history
• Dealing with audit failures and challenging findings

Workshop - risks of opening and closing meetings of internal audits

• Hands-on exercise: Conducting a mock internal GMP audit