Capabilities
Batch documentation
Every batch has a record. Every test result is documented for the batch it belongs to, in a certificate of analysis and a batch record.
Without documentation, a test result is only a claim. Kept together with its batch, it shows what was specified, what was made and what the independent laboratory measured.
Clear records make batches comparable over time, and they make it easy to answer questions about a batch later.
What the documentation covers
The certificate of analysis summarises the test results of a batch: HPLC purity, identity by mass spectrometry and endotoxins, each measured by an independent laboratory. The batch record keeps everything about the batch together: its specification, its production and its test results.
Batch against batch
Because every batch goes through the same tests and is documented in the same format, results can be compared from one batch to the next. Deviations become visible, and each batch can be traced back to its specification.
Measured independently
Documentation is only as good as the measurements behind it. That is why every batch is tested by an independent laboratory that is separate from the partner who made it.
Frequently asked questions
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The results of the tests carried out on a batch: HPLC purity, identity by mass spectrometry and endotoxins, together with the batch they belong to.
Yes. Every batch has its own certificate of analysis and batch record.
An independent analytical laboratory that is separate from the partner who made the batch.
The certificate shows the results. The batch record links them to the specification and the production of the batch, so questions about a batch can be answered later.