Certificates of analysis or conformity
As part of the Quality Control (QC) process the Specials manufacturer will issue either a Certificate of Analysis (CoA) or Certificate of Conformity (CoC) with every product released under an MS licence.
A CoA must be issued for every Special manufactured as part of a batch.5 It provides evidence that a sample of the final product has been tested for compliance with the necessary physical, chemical and microbiological specifications.
The certificate must state the batch number (which must match the product in hand) as well as the specifications tested against, the results of the tests, the name of the person performing the tests and the date of testing.
A CoC is a statement document issued by the manufacturer which affirms their belief that the product conforms to the purchaser's specifications of formulation and strength and is of the appropriate standard. It does not need to be signed and will not contain a batch number or any test results.
Both documents provide assurances to the pharmacist and prescriber that the product is of the necessary quality for safe use by their patient. A copy of the CoA/CoC must be supplied to the local health authority as part of the dispensing and reimbursement process.