Reliable Implementation with our Quality Auditors

• Kickoff meeting with key stakeholders

  • Review the audit objectives, scope, and schedule. Set expectations and address any initial questions or concerns.

• Site tour and personnel interviews

  • Observe operational processes and practices to verify that they align with documented procedures and GMP requirements. This may involve inspecting facilities, equipment, and production activities.
  • Assess personnel’s understanding of GMP requirements and adherence to procedures. This helps gauge the effectiveness of training and the implementation of procedures.

• Review documentation and data

  • Examine the documentation related to the processes being audited. This includes SOPs, records of deviations, corrective actions, and training logs.

• Hold closing meeting

  • Conduct a closing meeting to present the audit preliminary findings to key stakeholders. Discuss the results, recommendations, and any immediate concerns.