Most import decisions are made on documents: a GMP certificate arrives, the dossier looks complete, and a purchase order follows. That sequence is where problems usually start. A certificate tells you a facility was inspected on a particular date by a particular authority. It tells you very little about whether your specific product will be available, documented correctly, or delivered on the date promised.
1. Ask which registration dossier already exists
The most useful first question is not about the factory but the paperwork. Ask whether a CTD or ACTD set has already been compiled, for which markets, and in which language. A manufacturer with existing dossiers for your region has already answered most of the regulatory questions you would otherwise spend a year on. If the answer is that dossiers are prepared on request, ask to see one first.
2. Verify the certificate is for the right dosage form
GMP compliance is granted per dosage form. A facility certified for oral solids is not automatically certified for sterile injectables, and the reverse is equally true. This distinction matters more than buyers expect, because sterile production involves separate cleanroom classification, terminal sterilisation capability and aseptic processing validation that a tablet line simply does not have.
3. Confirm the product name format you will receive
Ask how product names are listed in the dossier — INN name, trade name, or a national monograph name. Your authority may have specific expectations. In Latin America in particular, the submitted name often has to match a name already approved locally, which is a translation and regulatory question, not merely a clerical one.
4. Ask what is released with each shipment
A batch should not leave the facility without a Certificate of Analysis issued against registered specification. Ask whether this is standard for every shipment or available on request. The second answer warrants further discussion.
5. Establish who owns the registration file
Ask who is the marketing authorisation holder in your market. If the supplier holds it, that is commercially convenient but creates dependency. If you hold it, you have more control but more responsibility. Either arrangement works; what matters is knowing which one you are in before committing.
6. Discuss lead times before agreeing prices
Lead time is a function of production scheduling, stability data availability and registration status. A price valid only while stock exists is not a reliable basis for planning. Ask how lead time is calculated and what happens to it if your registration timeline slips.
7. Test responsiveness on a technical question
Send a question about specification, dissolution profile or storage conditions. The quality of the reply tells you more about the relationship than any brochure. A supplier who answers technical questions directly — including saying 'I will check and come back' — is different from one who replies with a marketing document.
8. Confirm the certificate of free sale is current
Some authorities require a Certificate of Free Sale alongside the dossier. Ask whether this is maintained and by which authority it is issued.
This article reflects general regulatory practice and does not constitute legal or regulatory advice. Requirements vary by market and change over time — always confirm against the current requirements of the authority in your country.
Both structures organise a registration dossier. They are not interchangeable, and choosing the wrong one adds months to your timeline.
A Chinese GMP certificate confirms compliance with Chinese regulatory requirements. It is not a foreign approval, and it is not a substitute for your own authority's assessment.