SOP Library

Pharmaceuticals · Quality Assurance

Batch Record Review

Pharmaceuticals Starter Pack · pharmaceuticals-starter

QA review of executed batch records

PharmaceuticalsQuality AssuranceStarter pack

Overview

Batch Record Review 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. Verify batch lineage — Match batch to master formula and material lots

  2. Check critical process values — Review CPP logs for excursions and deviations

  3. Issue release decision — Approve, reject, or escalate with QA signoff