Requesting Batch Documents: What to Ask For and When

The two documents to request first — A Certificate of Analysis and the underlying HPLC chromatogram. The certificate states the result; the chromatogram shows how it was produced. Together they answer most of what a goods-in review asks.

undefined

What to request at enquiry stage — A sample certificate and analytical record from a recent lot, so the documentation standard can be assessed before any commitment. This is a reasonable request and a supplier operating a documentation process can usually fulfil it from the previous batch.

undefined

What to request at quotation stage — Confirmation of the documentation package included in the price, the format in which it will be supplied, and whether the format can be adapted to an institutional template. Also confirm whether batch traceability records and retained sample information are available.

undefined

What arrives with the shipment — Certificate of Analysis referencing the delivered lot, HPLC chromatogram, mass spectrum and batch traceability record. Additional documents agreed at quotation stage are included where applicable.

undefined

What to request afterwards — Where a downstream query arises, the retained sample and batch records are the reference point. Request the comparison in writing, quoting the lot number and the specific discrepancy.

undefined

What to do if a field is missing — If a certificate omits the method, the specification limits or the lot number, it cannot support a goods-in release on its own. Request the missing field before relying on the document rather than after the unit has been consumed.

undefined