Batch ID

BC-2024-0847

Compromised

Time Remaining

12:00

Mission briefing: Batch BC-2024-0847 (Cardivax 40mg Tablets) is pending final release. Review the evidence documents and respond to each integrity signal. Your decisions will be evaluated for inspection defensibility.

Batch:BC-2024-0847Date:14 March 2024Author:T. Okafor
BATCH MANUFACTURING RECORD — BC-2024-0847
Product: Cardivax 40mg Tablets | Facility: Site 4, Building C
Production Start: 14 March 2024, 06:30 | Production End: 14 March 2024, 22:15
Step 7.4 — Granulation blend: completed 11:20. Operator: T. Okafor. Equipment: GM-04.
Step 7.5 — In-process check: moisture content 2.8% (limit ≤3.0%). Recorded 12:05.
Step 7.6 — Tablet compression: Start 13:45. Equipment: TC-02.
Step 7.7 — Compression complete: 18:30. Yield: 98.4%.
Step 7.8 — QA in-process review sign-off: 18:55. Signed: J. Mensah.
Integrity Signal:J. Mensah is listed as QA in-process reviewer. However, Mensah's qualification for this product stage (TC-02 compression QA) expired 28 February 2024. Sign-off may not be valid.
Step 8.1 — Environmental monitoring: sampled 19:10. Results pending.
Step 8.2 — Final visual inspection: completed 20:40. Operator: T. Okafor.
Step 8.3 — Packaging initiation: 21:00. Line: PKG-3.
Step 8.4 — Packaging complete: 22:15. Pallet count: 14.

1 integrity signal flagged in this document.

Signal 1 of 3

Unqualified Sign-Off Identified

J. Mensah signed the QA in-process review for Step 7.8 (tablet compression). Mensah's qualification for this product stage expired on 28 February 2024 — before the batch was produced. The sign-off may be invalid under GDP requirements.

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