Deviation Impact Assessment

Equipment: Suppository Molding Machine

Provide a detailed description of the deviation encountered during qualification activities.

Classify the deviation (e.g., Major, Minor, Critical) based on its impact on product quality and compliance.

Assess the potential impact on the product and patient safety due to the deviation.

Evaluate how the deviation affects data integrity and compliance with regulatory standards.

List all batches or studies that may be affected by the deviation.

Outline the investigation process including root cause analysis and findings.

Detail the CAPA plan developed to address the deviation and prevent recurrence.

State the decision regarding re-testing or re-qualification of the equipment.

Document the final disposition from Quality Assurance regarding the deviation.