Documentation
EMA Pharmaceuticals delivers a CERTIFICATE OF CONFORMITY (COC) systematically for each batch that certifies that the delivered items have been produced and controlled according to the validated drawings and quality assurance procedures in place.
It also attests to their compliance with the agreed specification limits.
For EMA CLEAN - CERTIFIED CAPS, an additional CERTIFICATE OF ANALYSIS (COA) is issued, providing data of the controls performed on the goods.
A CERTIFICATE OF IRRADIATION is delivered with each batch of caps which are “Ready-to-be-used”.
It certifies that the validated irradiation process has been applied, assuring a SAL (sterility assurance level) of 106.