Deviation Impact Assessment

Deviation Details

Equipment: Extruder (Single Screw)

Area: Production/Pellets

Criticality: Major

Product Impact: Direct

CSV Required: Yes

Classification

Classification of the deviation as Major due to direct impact on product quality and patient safety.

Product/Patient Impact

This deviation has a direct impact on the quality of the pellets produced, potentially affecting patient safety and product efficacy.

Data Integrity Impact

The integrity of the data generated during the extrusion process may be compromised, necessitating a thorough review and validation of all related data.

Affected Batches/Studies

List of affected batches/studies:
– Batch #001234
– Batch #001235
– Study #XYZ456

Investigation

An investigation will be initiated to determine the root cause of the deviation, including a review of process parameters and equipment performance.

CAPA

Corrective and Preventive Actions (CAPA) will be developed based on the findings of the investigation to prevent recurrence of the deviation.

Re-test/Requalification Decision

A decision on re-testing and re-qualification of the extruder will be made based on the investigation results and CAPA implementation.

QA Disposition

The Quality Assurance department will review the findings and determine the appropriate disposition of affected products and processes.