What is lot genealogy? Batch records and traceability explained

Lot genealogy is the record of which input lots went into a product lot and where that lot went. For a peptide, it links resin, protected amino acids and reagents to the crude batch, the purified fractions, the lyophilised lot and finally each labelled vial. A batch record documents each step, so problems can be traced backwards and forwards.

What does a peptide lot's genealogy look like?

Stage	Linked records
Raw materials	Amino acid derivative lots, resin lot, reagent lots
Synthesis	Synthesis batch record, crude lot
Purification	Column runs, pooled fractions
Lyophilisation	Freeze-dry cycle, final lot number
Filling and labelling	Vial count, printed lot number
Distribution	Orders shipped per lot

What does ICH Q7 require?

ICH Q7 defines a batch (lot) as a specific quantity produced in a process so that it is expected to be homogeneous, and requires batch production records that make each batch traceable, including raw-material lot numbers and yields. These principles are the basis of traceability in API manufacture.

Source: ICH Q7 Good manufacturing practice for active pharmaceutical ingredients

Why does genealogy matter to a research buyer?

If a raw-material lot is found faulty, affected product lots can be identified.
If a buyer reports a problem, other vials of the same lot can be located.
Combined with retention samples, it allows a lot to be re-examined.

What can a buyer reasonably ask?

The lot's CoA and test date.
Whether the supplier can identify the manufacturing batch behind the lot.
Whether retained material exists for re-testing.

How does Sable document lots?

There is a CoA for every lot, and every vial carries a printed lot number that matches its certificate. A CoA is emailed within 2 hours of a request.

Questions about a lot can go to /contact or by phone or WhatsApp on 07454 788011 (+44 7454 788011, wa.me/447454788011).

Frequently asked questions