Pharmacy AI · Module 4 · Unit 3 · Practical 3

Batch Record Review & Data Integrity Audit

Aim — To review a completed batch manufacturing record line by line, identify every good documentation practice and data integrity breach, classify each against ALCOA+, and reach the correct release decision as the Qualified Person’s delegate.

Your review

Batch ALZ-TAB-2410 — paracetamol 500 mg tablets, 240,000 units — has been manufactured and the record has come to you for review before release. You are reviewing on behalf of the Qualified Person.

  1. Click any line you believe is a finding. Clicking a sound line costs you — over-flagging a record is as unhelpful as missing a breach.
  2. There are eight genuine findings in the record. Some are obvious, some are only visible if you check one number against another.
  3. Each finding must then be classified against ALCOA+ and given a criticality.
  4. Finally you make the release decision. Releasing a batch with a critical finding is a regulatory failure; rejecting a good batch is a commercial one.

A Record Integrity Index tracks the state of the batch record itself as findings are confirmed — it describes the batch, not your performance.

Assessment rubric

Assessment criteriaMarks
Findings identified (8 × 5)40
False positives avoided10
ALCOA+ classification20
Criticality assignment10
Release decision15
Corrective and preventive action5
Total100

Pass 50. The Record Integrity Index describes the batch record, not the student, and is reported separately.

Achievement badges

🔎 Every Finding🎯 No False Positives 📐 ALCOA+ Fluent⚖ Correct Disposition🏅 QP Ready

Open the batch record

Alizon Pharmaceuticals · Quality Assurance · batch record review before release

Review report & disposition

Complete the review to generate your report, then write and submit it below.