01Sourced
Qualified raw material
Credentialed suppliers, with identity and lot documentation attached from the start.
- Supplier qualification
- Identity records
- Lot documentation
Chain of custody
From qualified raw material to a vial with a traceable lot number.
Written by Eric W. Anderson, MD · Last updated
Six checkpoints. Each creates or reviews a record, so the finished item can be traced back through the process that produced it.
01
02Quarantined
Held before use
Material stays out of production until identity and safety checks are reviewed and released.
- Incoming hold
- Document review
- Release or rejection
03Built
One accountable process
Synthesis, lyophilization, filling, and labeling live in a single traceable batch record.
- Synthesis
- Lyophilization
- Filling and labeling
04Sealed
The container is part of the product
Qualified vial glass and closures give consistency from lot to lot.
- Qualified vial lot
- Consistent components
- Container records
05Verified
Independent finished-batch testing
An outside lab adds a separate source of evidence beyond the manufacturing record.
- Identity and purity
- Sterility and endotoxin
- pH
06Delivered
The lot number connects the record
The lot on the vial links back to every document created along the way.
- Source record
- Test results
- Fill and dating record
A test performed outside the supply chain is a separate source of evidence.
That is why independent finished-batch testing carries weight: it is not the manufacturer grading its own homework.
Related reading
What a certificate of analysis establishes
How to read the document attached to a specific lot — and what it cannot establish.
Purity, sterility, and endotoxin
Three different properties measured by three different tests.
How peptides are prescribed
The clinical and pharmacy steps around a prescribed preparation.