Matching a Certificate to a Batch and a Container

Record the container before searching

Keep a readable photograph of the label and copy its product name, form, nominal quantity and lot code. Record the order reference separately. Where one order contains several lots, make one entry per lot so a result cannot inadvertently be assigned to all of them.

Distinguish the material description from its quantity. A nominal 10 mg fill does not establish an assay result, and a familiar abbreviation may omit a salt form or other variant. Resolve an unclear label with the supplier before choosing a certificate. The guide to lot numbers and traceability explains the identifier records.

Follow the identifiers across the documents

Start with the container lot and the producer batch if it differs. Trace the batch to the laboratory sample, then to the report number and revision. At each change of identifier, look for a written cross-reference. If the issue is who collected, transferred or received the sample, use the chain-of-custody guide to check that part of the record.

ICH Q7 describes batch and issuer details on pharmaceutical API certificates and how an intermediary’s certificate refers back to the original. That is a useful way to read a chain of documents. The link between a research container and its tested sample still has to be shown in the actual records. ^[A1]

A matching chain can contain different codes

The identifiers below are fictional. Read down the table to see how a seller lot can be traced to a report even when the laboratory uses its own sample numbering.

With the links in this example, report R-119 revision 2 for sample L-073 can be traced via producer batch M-208 to seller lot S-041. If the report names L-074 instead, stop at the sample-to-report link. Ask for the document that explains the difference and keep both identifiers as written.

Once the identifiers match, record the particular sample and tests covered. A link from one sample to a lot does not show that every container was individually tested.

Handle a mismatch without guessing

1. Preserve the label photograph and original document. Record the disagreement as written, including spaces, suffixes and ambiguous characters such as O and 0.
2. Check whether you are comparing a seller lot with a laboratory sample ID, or two versions of the same report. Look for an explicit cross-reference.
3. Ask the issuing organisation or supplier to explain the connection and provide the applicable record. Keep any correction with the earlier version.
4. Until the connection is clear, record the certificate-to-container match as unverified. Follow your laboratory's receipt and acceptance procedure.

An unavailable report is a documentation gap; a different sample result is evidence about a different sample. Neither gives you a basis to mark the container as analytically accepted. Use the quality documentation overview to identify the evidence you need.

Send a request that support can resolve

For the fictional mismatch above, a useful question would be “My container shows S-041. The sample record for producer batch M-208 shows L-073, but report R-119 revision 2 lists L-074. Which report applies to this container?” Use your own label and document details when making a request.

On the contact form, choose Batch report or COA and type both identifiers in the message. Keep the label image and document. If support needs copies, ask how to send them. The ordering and documentation FAQ covers other support questions.

After matching the record, assess what the reported tests establish. Identity, purity and assay answer different questions, even when they appear on one certificate.