How To Verify GMP Certificates?
Why To Verify GMP Certificates First?
Nowadays, it is essential to verify certificates provided by chemical suppliers.
Not verifying them before the import can sometimes be disastrous.
We shared a story about this disaster in another blog.
Although most suppliers are honest and provide genuine certificates, chemical importers should verify them to ensure safety, right?
1. How To Verify Chinese GMP Certificates
If you’re unfamiliar with GMP, it stands for Good Manufacturing Practice.
All pharmaceutical products must be produced in accordance with GMP Guidelines.
Verifying Link No. 1: China CFDA Website Search Interface (https://www.nmpa.gov.cn/yaopin/index.html-Search API in English or Chinese):
Let’s search for one API, ‘bacitracin ‘, from NCPC Huasheng. We enter ‘bacitracin’ into the search box and click Enter; you will see the interface below:
There, you can compare the Manufacturer’s Name and API on the SFDA website with the name of the GMP certificate in your hand. Please note that all Invalid and canceled GMPs won’t be shown here.
Verifying Link No. 2: Center for Drug Evaluation (Search API in Chinese Only): This is the website for APIs/Finished formulations under Evaluation, which are not yet fully certified.
http://www.cde.org.cn/yfb.do?method=main (2019.10.30 still blocked)
If you cannot find the corresponding GMP on the SFDA website, verify Link No. 2. Please note that you can only use keywords in Chinese.
We also search for the Chinese Name of Bacitracin (杆菌肽); you will see the interface below:
2. How To Verify EU GMP Certificates
The interface of the link above is as follows:
Let’s search Bacitracin and click Enter. The interface is as follows:
As you can see, there are only 2 European GMP manufacturers listed in the EDQM system:
Xellia Pharmaceutical and Krka d. d.
We searched for bacitracin zinc, but found no results, as shown below.
However, as shown above, Xellia has EU GMP certification for Bacitracin Zinc.
3. How To Verify ISO Certificate
The ISO verification interface is as follows:
Please note the following points:
1. You can type Chinese characters only.
2. The keyword is No Less Than 5 Chinese Characters.
3. You can search by ISO No. or by Applicant Name.
We entered 华北制药华胜 （NCPC Huasheng）into the search box and clicked Enter; the interface is as below: (there is a CAPTCHA)
Click 确认, you will see the interface below:
Click on the company name, and you will see a similar captcha as below:
After the CAPTCHA, you will see the interface below.
Green buttons indicate ISO Valid, while grey buttons denote Invalid or expired.
Of course, NCPC Huashen also has an ISO Expired. We can drag the page down, and you will find that their ISO certificates have expired, as shown below:
So now you should know how to verify an ISO certificate from a supplier.
The key is to learn to type Chinese. If you have any difficulties verifying, we will help you for free.
4. How To Verify USFDA Certificates:
First Check: the FDA Certificate Verifying Link:
Secondly, check the search Interface of Establishment Registration & Device Listing on the FDA website
Using those two links, you can verify whether your supplier is registered with the FDA.
The 3rd helpful link is the DMF data for the USUMF lookup.
Click on the first link to see the interface below. The FDA has detailed procedures for verifying an FDA certificate for different parties. The first procedure requires registration, which is more complicated than the other three.
If you encounter any difficulties verifying information, please get in touch with us, and we will assist you at no additional cost.
Please find us at ella@octagonchem.com
5. How To Verify TGA Certificate
TGA is the Australian equivalent of the FDA and issues Australian GMP certificates to suppliers who wish to distribute their pharmaceutical products in Australia.
You can verify a TGA certificate through ARTG Search.
Let’s say you want to verify whether your supplier, Alphapharm Pty Ltd, gives you a genuine certificate for its minoxidil products. You click on the verifying link above, and you will see the following interface:
After you type in minoxidil and click on the search button, you will see the search results below:
You will have 15 results matching minoxidil and find that Alphapharm is a TGA-registered supplier.
If you have not found any results for Alphapharm, the certificate is likely fake.
If you encounter any difficulties verifying a certificate, please don’t hesitate to contact us at your convenience.
6. How To Verify Chinese Veterinary GMP
Customers asked us how to verify compliance with the Chinese Veterinary GMP, so we have listed the details below.
However, to verify the Vet GMP, you must be familiar with some Chinese, as all the interfaces on the government website are in Chinese.
You can verify the Chinese Veterinary GMP Certificate through the National Veterinary Drug Basic Information Database website.
Below is the interface after you click on the link above
If you click on the first folder in the drop-down menu on the left, you will be directed to the Veterinary Manufacturer Data folder.
You can search by manufacturer name, veterinary drug permit number, and GMP number to verify.
The interface is something like this:
Of course, you can click all the folders on the left to verify the information in your hands and compare it for consistency.
If you experience difficulties using the database due to the Chinese characters, please don’t hesitate to contact us for assistance at any time.
Disclaimer:
This content is for informational purposes only and is intended for business-to-business communication within the pharmaceutical industry. It is not intended as medical advice. The manufacture, import, and use of API must comply with all applicable laws and regulations in the relevant country or region.
This blog post is informational only and does not constitute medical advice.
Always consult a healthcare professional before starting any new medication or treatment.
