Book 5 · Part 1
Quality Control
Batch release decisions and non-conforming product handling.
SOP 5.01 — Batch Release
A shipment is not released simply because production is complete. Review:
- Batch production record
- Certificate of Analysis
- Product testing
- Packaging verification
- Sachet weight
- Seal integrity
- Label review
- Expiry information
- Batch coding
- Shipping documentation
Quality approval must be recorded as APPROVED, QUARANTINED or REJECTED.
SOP 5.02 — Non-Conforming Product
Immediately isolate affected stock and mark it "DO NOT SELL — QUARANTINE".
Create an incident report containing:
- Batch
- Quantity
- Problem
- Date
- Photos / evidence where available
- Supplier response
- Investigation
- Corrective action
- Final decision