SOP Library

Pharmaceuticals · Quality Assurance

Deviation Reporting Process

Pharmaceuticals Starter Pack · pharmaceuticals-starter

Deviation capture and investigation initiation

PharmaceuticalsQuality AssuranceStarter pack

Overview

Deviation Reporting Process is included in the Pharmaceuticals Starter Pack industry pack. Import the pack into TrueSOP to use this procedure with linked checklists and schedules.

Scope

Frontline operators, shift leads, and location managers. Adapt steps, roles, and evidence requirements to your organization after import.

Procedure

3 steps from the industry pack

  1. Contain impacted material — Quarantine affected lots and halt related operations

  2. Document deviation details — Record event context, severity, and potential impact

  3. Assign investigation owner — Open investigation with CAPA timeline