EMA guarantees the conformity and quality of each batch by providing different certificates
The issuance of certificates for providing data of the controls
Certificate of Conformity (COC)
Systematically delivered 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.
Certificate of Analysis (COA)
For EMA CLEAN - CERTIFIED CAPS, an additional COA is issued, providing data of the controls performed on the goods.
Certificate of Irradiation (COI)
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.