Quality and Batch Documentation

Choose the record you need

If you have a certificate of analysis (CoA), read its test, result and acceptance limit together. Check which version of the specification supplied the limit. ICH Q6A describes this relationship for pharmaceutical specifications. The evidence for a Knockout Labs lot must come from its own records. ^[A1]

Follow a claim back to its evidence

If a percentage appears on a vial, find the corresponding result in the lot report. Check the test method and what the percentage is a percentage of. The guide to the 99%+ purity statement shows what can be concluded from a chromatographic area result and which questions still need other evidence.

For a claim about sterility, temperature-controlled shipping, pharmaceutical grade, GMP or independent testing, ask for the record that covers that specific claim. A description of how a method works gives you no lot result on its own.

Check who supplied the material, who issued the certificate, who performed the test and who recorded the release decision. The sourcing and release guide explains those roles. If you are assessing the business as well as the material, use supplier qualification to specify the organisational records you need.

Read results by the question they answer

Identity and chemical form. Start with identity, purity and assay to separate the three questions. Then use why purity does not prove identity, mass-spectrometry identity evidence and salt forms and counter-ions for the relevant detail.

A peak in an HPLC trace. Start with how HPLC separates compounds, then read the chromatogram alongside the integration report. The guides to common impurities and where impurities can arise during peptide synthesis help frame a question about a minor peak. Assigning that peak an identity takes evidence for the sample.

Amount and other measured attributes. Use assay, water content and residual solvents for their different reporting bases. Net peptide content concerns the peptidic fraction, including peptide impurities, rather than only the intended peptide. [A4] Sterility, endotoxin and bioburden explains three separate microbiological questions.

Check whose sample and whose report you have

1. Connect the document to the container using certificate-to-batch matching and lot-number traceability.
2. Identify the testing role with manufacturer versus independent testing and laboratory verification.
3. Follow the submitted sample through chain of custody. A matching identifier alone does not document every transfer.
4. Compare results with the applicable acceptance criteria, keeping missing evidence separate from a reported failure.

Keep unanswered questions visible

Record exactly which question is open. If the report lacks a link to the lot, ask technical support for that link. If the lot matches but the report gives no fill measurement, request the document that defines the quantity on the label.

For example, a lot-matched certificate may report a chromatographic result while the specification describes a nominal amount in milligrams per vial. You can record the chromatographic result. Leave the measured quantity per vial open until a suitable quantitative result is supplied. This is an illustration of how to read the two records.

The claims boundary and research-use policy set the wider context. These pages help readers examine evidence; they do not establish suitability for human or veterinary use.