How To Run Background Checks For Chemical Manufacturers In China?
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Background checklist for chemical manufacturers
In our last post, we discussed how to run background checks for all chemical suppliers.
This post will discuss the details of extra background checks for manufacturers.
You do not have to worry about when you find yourself a manufacturer.
You need to ensure your manufacturer is reliable and can deliver.
In the Chinese chemical industry, chemical manufacturers are mainly divided into three classes by product types and quantity:
Pharmaceutical manufacturers for APIs;
Fine chemical manufacturers and intermediate factories;
Manufacturers of reagents and custom-synthesis providers.
We will explain each type one by one.
#1 GMP (Issued by China State FDA).
The first certificate you need to check for a pharmaceutical manufacturer is the GMP.
Because it is the essential certificate for APIs, you must register APIs in your MOH before importing them.
If they have GMP, there is no need to check DML.
Once you have the GMP and don’t know how to verify it, you can check our post on how to verify Chinese GMP online.
#2. GSP.
GSP is a Good Practice for medicine supply and distribution.
It has nothing to do with chemical manufacturing; please ignore it.
If they have it, it is a bonus.
#3. Technical Data Support.
To obtain an active pharmaceutical ingredient approved by CFDA, the API manufacturer must provide a complete set of documents to the authority.
If they don’t have DMF/Stability data/MOA for your MOH registration, please contact another manufacturer who can.
#4. DML (drug manufacturing license).
DML is valid for 5 years and 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 the local FDA rather than the state FDA. If your supplier has DML, it is proof that they are a manufacturer.
#5. Foreign registration status.
If the manufacturer has registered many APIs in foreign countries for export, it is more likely to be the manufacturer.
#6. Patent/Intellectual Property.
If your supplier has many patents, they are powerful in R&D, which is a bonus for a manufacturer’s credibility.
#7. 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 whether your supplier has an ISO certificate for manufacturing their chemicals.
Please pay close attention here, as many suppliers claim they have an ISO certificate.
However, many ISO scopes cover distribution, sales, management, and production.
The ISO scope should involve chemical production and manufacturing, not other types.
The chemical manufacturer 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 of dealing with a manufacturer.
With this certificate, your supplier can enjoy more tax cuts.
Patents
Patents are essential for pharmaceutical manufacturers, and manufacturers with patents are more willing to invest in R&D.
REACH
To export chemicals to Europe, you need a REACH certificate. If your supplier has one, it is a bonus. Getting a REACH certificate is easier for a manufacturer than a trader.
Pollutant Discharge Permits.
If your supplier happens to have this certificate, bingo, it is more likely they are the actual manufacturer.
3. Checklist for Reagent and custom-synthesis manufacturers
Due to product differences, reagent and custom-synthesis providers differ from fine-chemical manufacturers, but their certificates are the same.
So we won’t waste extra time explaining it again.
In our next post, we will share some knowledge about the difference between GMP and DML.
