A batch of material without its paperwork is, for regulatory purposes, unusable — however good the material itself may be. Below is the minimum set and what each document is actually for.
Six documents
- CoA — Certificate of Analysis
- The test results for that specific batch against the declared specification. It is a per-batch document, not a per-product one — each batch has its own, showing batch number, manufacturing date and expiry.
- MSDS — Material Safety Data Sheet
- Hazard information, handling, storage and emergency response. Needed for occupational safety and for transport.
- CO — Certificate of Origin
- Confirms the country of manufacture. Used for customs and for the origin declaration in the registration dossier.
- CQ — Certificate of Quality
- The manufacturer's declaration that the batch meets its declared specification. It complements the CoA rather than replacing it.
- Manufacturer GMP certificate
- Evidence that the plant is recognised as GMP-compliant by its national authority. Check both validity and scope — a certificate for one line does not cover another.
- DMF or CEP
- The master file describing the manufacturing process, quality control and stability of the active substance. Not every material has one, but where it exists it substantially shortens the quality section of a registration dossier.
Pharmacopoeial grade
Materials must state which pharmacopoeial monograph they meet: USP, BP, EP, JP or IP. This is not a formality. For the same active, two pharmacopoeias can specify different impurity limits and different test methods, and the registration dossier has to stay consistent with the one chosen, from beginning to end.
Three questions that get skipped
- Is the CoA for the batch actually being delivered, or for a sample batch? Match the batch number on the certificate to the one on the container.
- Was the manufacturer's GMP certificate valid at the time the batch was made?
- Has the distributor held the goods under the declared conditions? Material that left the plant in specification can still degrade in an intermediate warehouse.