Batch documentation is the paper (or digital) trail generated during the manufacture and release of a single batch of material. It sits underneath the summarised Certificate of Analysis and is what a QC officer reviews before release.
Manufacturing record
The manufacturing record captures each step of synthesis: starting materials and their own certificates, coupling and deprotection cycles, cleavage conditions, and yield. For a solid-phase peptide synthesis batch, this is normally a step-by-step log signed by the operator.
In-process controls
During synthesis and purification, in-process checks confirm the batch is progressing as expected. These typically include intermediate HPLC checks after cleavage and after each preparative purification pass. Deviations are recorded and reviewed before the batch moves to release testing.
Release testing
Release testing is the final analytical package: HPLC purity, mass spectrometry identity, water content, counter-ion content, and any product-specific tests. The raw data files (chromatograms, spectra) are attached to the batch record, not just the summarised numbers.
Deviation and change control
If anything unusual occurred during manufacture — a temperature excursion, a swapped reagent lot, a modified purification gradient — it is captured in a deviation report attached to the batch record. Change control captures planned modifications between batches. Both give context to any variation seen in downstream use.
Release and disposition
The batch record closes with a release statement signed by a QC officer, confirming that all data have been reviewed and the batch meets the specification. The disposition (released, quarantined, rejected) is recorded here and is the trigger for shipment.