DEV-030164

minor • pending-closure • environmental

About this view

Deviation detail consolidates event narrative, impact scope, and containment progress into a single GMP-quality case view. QA triage decisions and risk assessment are tracked alongside impacted batches, lots, and equipment so release impact can be evaluated quickly. Attachments and immutable audit trail entries provide evidence continuity for inspections. Next actions focus on investigation linkage, due-date control, and closure readiness.

Event Narrative
Deviation identified during manufacturing. Investigation initiated per SOP-QA-012.
Impacted Scope

Batches: batch-00165batch-00166

Lots: lot-00165

Equipment: eq-00165

Containment and QA Triage
  • Batch quarantined pending investigation
  • Production halted on affected line
  • Affected lots placed on hold

QA decision: Rework

Risk score: 100

Attachments and Audit Trail

Attachments:

  • 2024-12-16 - Deviation opened by A. Williams