Extra Background checklist for chemical manufacturers
In our last post, we discussed how to run background checks for all chemical suppliers. In this post, we will discuss the details of extra background checks for manufacturers.
It is not that you have nothing to worry about when you find yourself a manufacturer. You need to make sure your manufacturer is someone reliable and who can deliver.
In the Chinese chemical industry, chemical manufacturers are mainly divided into 3 classes by product types and quantity: pharmaceutical manufacturers for APIs, fine chemical manufacturers and intermediates factories, manufacturers of reagents and custom-synthesis providers.
We will explain each type one by one.
1. Background Checklist For Pharmaceutical Products
GMP (Issued by China State FDA). The first certificate you need to check a pharmaceutical manufacturer is the GMP. Because it is the basic certificate for API need to register APIs in your MOH before you are allowed to import it. If they have GMP, there is no need to check DML. Once you have the GMP in your hand and you don’t know how to verify it, you can check our post on how to verify Chinese GMP online.
GSP. GSP is the Good Practice for medicine supply and distribution. It has nothing to do with the chemical manufacturing, please ignore it. If they have it, it is a bonus.
Technical Data Support. To get an active pharmaceutical ingredient proved by CFDA, the API manufacturer must provide a whole set of documents to the authority. If they don’t have DMF/Stability data/MOA for your MOH registration, you should try to contact another manufacturer who can.
DML (drug manufacturing license). DML is valid for 5 years and it is the first permit issued to a pharmaceutical manufacturer. This permit will allow them to produce an API and submit it for GMP approval. Before they get the product GMP, their API is not allowed for sale as a drug. DML is issued by Local FDA rather than State FDA. If your supplier has DML, it is extra proof that they are a manufacturer.
Foreign registration status. If the manufacturer has registered many APIs in foreign countries for export, it has a better chance they are the manufacturer.
Patent/Intellectual Property. If your supplier has tons of patents, it means they are very strong on R&D and it is a bonus for the credibility of a manufacturer.
Pollutant discharge permit. This permit is very common for chemical manufacturers. If they don’t have one, pay extra attention. They may not be allowed to produce APIs.
2. Checklist for fine chemicals and intermediates manufacturers
ISO certificate. Please check if your supplier has ISO for manufacturing their chemicals. Please pay close attention here, as many suppliers claim they have an ISO certificate. But there are many ISO scopes, on distributing, selling, managing, producing. The ISO here I am talking about is producing chemicals, not other types. For the chemical manufacturer, they should have ISO for manufacturing.
High-Tech enterprises. If your supplier is a certified High-Tech Enterprise by the government, you have a better chance that you are dealing with a manufacturer. With this certificate, your supplier can enjoy more tax cuts.
Patents. This is the same as pharmaceutical manufacturers. Manufacturers that have their patents are willing to spend money on R&D.
REACH. It is a certificate needed for chemicals to be exported to Europe. If your supplier has a REACH certificate, it is a bonus. As it is easier for a manufacturer to get a REACH than a trader.
Pollutant Discharge Permits. If your supplier happens to have this certificate, bingo, it is more likely they are the real manufacturer.
3. Checklist for Reagent and custom-synthesis manufacturers
Though the reagent manufacturers and custom-synthesis providers are separated from fine-chemical manufacturers due to the product difference, the certificates they have are pretty much the same. So we won’t waste extra time to explain it again. In our next post, we will share some knowledge about the difference between GMP and DML.