SOP AMU-011 · Part 2
Production Batch Control
Unique batch identity and full batch record.
Example batch identity: AMU-JP-260901-A — AMU / Japan / year-month-day / production lot. The final coding system must be approved and consistent.
Batch Record
- Manufacturing date
- Batch number
- Formula version
- Raw material lots
- Quantity produced
- Quantity rejected
- Packaging lot
- Operators
- QC checks
- Release status