The Certificate of Analysis is the batch-specific proof of quality. Which tests it summarises and why it matters for the dispensary.
A Certificate of Analysis (CoA) is the batch-specific proof of quality for a medicine. It summarises the results of the pharmaceutical tests carried out before a batch is released.
A CoA typically covers identity testing, assay of the relevant constituents and purity / contaminant testing – for example heavy metals, pesticides, microbiology, mycotoxins and other impurities.
Testing is based on recognised monographs and pharmacopoeias, in Germany in particular the German Pharmacopoeia (DAB) and the European Pharmacopoeia (Ph. Eur.). The CoA documents that the batch meets the applicable specifications.
For the pharmacy, the CoA is more than a formality: it is the basis for goods-in inspection and for compounding – and therefore part of pharmaceutical due diligence and liability. Verified professionals receive the batch-specific certificates via the professional area.