What does a formulator check before qualifying a new API or excipient supplier?
Answer
They check the regulatory filings before they check the price. A named pharmacopoeial grade, a DMF or ASMF reference number, the authority that issued your GMP certificate, and the markets your site is approved for decide whether qualification is even possible: long before commercial terms are discussed.
A regulatory affairs manager is building a supplier shortlist and needs to know, from your site alone, whether qualifying you is a six-month project or a non-starter.
Information to make clear
Use the fields that affect this buying decision. Leave unsupported claims out.
- Generic name and CAS number
- The unambiguous identifier for the molecule under discussion.
- Pharmacopoeial grade
- IP, BP, USP, EP or JP compliance decides which markets the material can enter.
- Polymorphic form or particle size, where relevant
- Two materials meeting the same monograph can behave differently in a formulation.
- Packaging and pack sizes
- Determines storage, stability handling and shipping cost.
- Approved markets
- The single fastest way for a buyer to disqualify or shortlist you.
- Minimum order quantity
- Development quantities and commercial quantities are different conversations.
Documents to prepare
State what can be published, shared on request or issued with an order.
| Document | What it supports | Suggested handling |
|---|---|---|
| Certificate of Analysis (CoA)May be requested at: with every batch | Batch conformance to the declared specification | Issue per shipment |
| Drug Master File reference (US DMF / EU ASMF)May be requested at: at shortlisting: the number itself is the check | That the manufacturing and quality detail is already on file with the authority | Publish |
| Certificate of Suitability (CEP/CoS)May be requested at: by european buyers, early | EDQM confirmation that the European Pharmacopoeia monograph controls the substance | Publish |
| GMP certificateMay be requested at: vendor qualification | Good Manufacturing Practice status, and critically which authority inspected you | Publish |
| Manufacturing licence and site registrationMay be requested at: vendor qualification | That the named site is licensed to produce the material | Publish |
| Residual solvent and elemental impurity statementMay be requested at: technical evaluation | Control against ICH Q3C and Q3D expectations | Share on request |
| Stability data summaryMay be requested at: before formulation work starts | Shelf life and storage conditions under a recognised protocol | Share on request |
Details to ask in an enquiry
Collect only the information needed to assess the request and respond.
- Product and pharmacopoeial grade
- Decides whether a quote is possible.
- Required documents
- A buyer asking for a CEP and a buyer asking for a CoA are at different stages.
- Quantity and packaging
- Development, pilot and commercial volumes price differently.
- Destination market
- Registration requirements follow the market, not the molecule.
- Sample or working-standard requirement
- Sample requests need a different internal route from commercial enquiries.
- Timeline for qualification
- Tells you whether this is a live project or a market study.
Related questions
Should we publish our DMF number publicly?
Yes. The filing itself is a matter of record with the authority and the number is what lets a buyer verify you without contacting you. Publishing it converts an unverifiable claim into a checkable fact, which is the entire job of the page.
What should we say about markets we supply but are not registered in?
Say exactly that, in those words. "Supplied to" and "registered in" are different statements and buyers know the difference. Blurring them is the kind of thing that surfaces during an audit and costs you the account rather than the enquiry.
Is a product page enough, or do we need a full regulatory section?
A product page that names grade, DMF or ASMF status and approved markets does most of the work. A separate regulatory page helps when you have several sites with different approvals, because the buyer needs to know which site makes which product.
This is an editorial checklist, not a compliance standard. Requirements vary by market, customer and contract. Confirm current requirements with the responsible technical and commercial teams.
Plact Research. Plact's editorial desk for buyer-evidence guides. The guides organize common buyer questions, documents and enquiry fields. Requirements should be checked against current standards, regulations and contracts.