14/15 September 2021
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:
According to the EU GMP Guide Part I, certificates of analysis provide an overview of test results obtained from a product or a material. This also includes the assessment of compliance with the specification determined.
Section 11.4 of the EU GMP Guide Part II on certificates of analysis requires an authentic certificate of analysis for each batch of an intermediate or API. Among other things, this certificate should contain the following information:
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 don´t have this concretisation.