Good Manufacturing Practices (GMP) Auditing Training Course

Course Overview

Learning Objectives

• Explain GMP principles and their role in maintaining product quality, safety, and consistency.
• Interpret applicable GMP requirements and translate them into practical audit criteria.
• Develop risk-based GMP audit plans, checklists, and schedules.
• Evaluate manufacturing facilities, equipment, personnel practices, and production controls.
• Review quality documentation, batch records, standard operating procedures (SOPs), and traceability records.
• Collect and verify objective evidence through interviews, observations, and document reviews.
• Identify, classify, and document GMP nonconformities and compliance gaps.
• Assess contamination control, hygiene practices, material handling, and storage conditions.
• Evaluate corrective and preventive actions and verify their effectiveness.
• Prepare clear audit reports and communicate findings to relevant stakeholders.

Who Should Attend

Learning Outcomes

• Interpret relevant GMP principles and regulatory expectations within the applicable industry.
• Define audit scope, objectives, criteria, and evidence requirements.
• Prepare structured audit plans and risk-based checklists.
• Evaluate compliance across production, quality, documentation, and facility controls.
• Verify the accuracy, completeness, and traceability of manufacturing records.
• Identify deficiencies in hygiene, contamination prevention, and material control.
• Distinguish between observations, minor deficiencies, and significant nonconformities using applicable classification criteria.
• Document findings using objective evidence and clear statements of noncompliance.
• Evaluate root-cause analysis and the adequacy of CAPA plans.
• Prepare audit reports and follow-up plans that support sustained GMP compliance.

Course Outline