Eight documents to ask your API supplier for, before the PO.
A buyer can agree on price in an afternoon. A quality team takes weeks to approve a new source, and it does it on paper. Asking for these eight documents with the quote, not after the purchase order, is the fastest way to know whether a supplier will pass.
1. Certificate of analysis
The results of a specific manufacturing lot against a specific monograph. Check that it names the manufacturer, the lot, the pharmacopeia and its edition, and that the results sit inside your specification, not just inside the monograph.
2. Safety data sheet
Hazards, handling, storage and transport, in the current format. Your warehouse and your freight forwarder need it before your quality team does.
3. Specification and test methods
The limits and methods behind the certificate. If your laboratory cannot reproduce a result, the certificate is only a promise.
4. Certificate of origin
Customs asks for it, and it tells you where the ingredient was actually made. It should match the manufacturer on the certificate of analysis.
5. Evidence of the manufacturing site
A GMP certificate or the outcome of a recent inspection of the source. Supplier qualification starts with the plant, not with the distributor.
6. Regulatory access: DMF or CEP
In the United States, an API manufacturer can file a Type II Drug Master File with the FDA. The FDA does not approve a DMF on its own; it reviews it when an application refers to it through a letter of authorization. In Europe, the equivalent route for many ingredients is a Certificate of Suitability (CEP) issued by the EDQM. If your filing needs either, ask early: the letter comes from the manufacturer, under a confidentiality agreement.
7. Impurity statements
Residual solvents under ICH Q3C, elemental impurities under ICH Q3D, and a TSE/BSE statement when the process could involve animal-derived materials.
8. Nitrosamine risk assessment
Since 2020 the FDA has asked manufacturers to assess and control nitrosamine impurities, and its guidance was revised in September 2024. Sartans such as losartan, and metformin, were among the products recalled between 2018 and 2020. Ask the source for its assessment.
The documents should match each other: one manufacturer, one lot, one monograph.
General information, not regulatory advice. Your regulatory team decides what your file needs. R.J. Chemicals confirms which documents are available for each product with the quote.