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How to capture and report lot genealogy for final product

edited Oct 26, 2023 11:01PM in Manufacturing 1 comment

Summary:

Requirement is to capture lot genealogy details for multiple batches completed in CMO work order and provide report showing lot genealogy with material consumed for each batch

Content (please ensure you mask any confidential information):

The process has three stages

1) Buy API > Lot number L1001

2) Level 1 - Drug Product(DP)

> Contract Manufacturing work order- WO1001

> Five batches are completed using same API lot L1001, but DP batch sizes are different

Lots

DP001

DP002

DP003

DP004

S1234

3) Level 2- Final Drug

 > Contract Manufacturing work order- WO1002

Uses DP batches

Lot FD001 uses DP001

Lot FD002 uses DP002

Lot FD003 uses DP003

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