Professional Documents
Culture Documents
(CoA)
At times of outsourcing and globalisation, the significance of Certificates of Analysis
(CoA) is growing. Ultimately, the user of such certificates has to rely on their accuracy
and completeness.
There are CoAs for excipients, APIs, packaging materials and finished products. A
closer look at the guidelines shows that there are a few regulatory requirements which
are often unknown. Requirements can be found in the following sets of rules:
You can find specific requirements regarding CoAs in these GMP guidelines. This is a
difference to other quality guidelines like e.g. ISO 9001, where you dont have this
concretisation.