COA, MSDS, and DMF: Essential Documentation for Chemical Imports

Certificate of Analysis (COA)

The COA is the batch-specific quality passport. It records the test results for every parameter in the product specification — identity, assay, related substances, residual solvents, heavy metals, microbial limits — against the monograph or in-house spec. The COA you receive should match the batch number on your container, be signed by an authorised QA representative, and show test results within specification across the board.

If you see "complies" against a parameter without a numerical result, push back. "Complies" tells you the supplier believes it complies; the number tells you what the actual value was.

Material Safety Data Sheet (MSDS / SDS)

The SDS describes the hazards of the substance, safe handling procedures, first-aid measures, and transport classification. It must be in the GHS (Globally Harmonized System) 16-section format and dated within the last five years. For dangerous goods shipments, the SDS is also what your freight forwarder uses to assign UN numbers and class — getting this wrong delays the shipment.

Drug Master File (DMF) and CEP

For Active Pharmaceutical Ingredients, the DMF is a confidential dossier filed by the manufacturer with the regulatory authority, describing the chemistry, manufacturing process, and controls. You do not receive the DMF directly — you receive a Letter of Authorisation that allows the regulator to review the DMF on your behalf during your own product registration.

The European equivalent, the CEP (Certificate of Suitability), is publicly issued by EDQM and confirms that the API meets European Pharmacopoeia standards. A CEP-holding supplier is usually the path of least resistance for European market entry.