Questions about cGMP in a pharmaceutical company in China

[Nancy_Jing]

I'm working in a pharmaceutical company in China, which want to be approved under cGMP from FDA. Nevertheless, I have some questions about the cGMP certification, that is, if the company wants to be certified, is there any drug product needed prior to the FDA on-site inspection coming? For example, a building of oral solids need cGMP certifying, whether it's necessary to provide a kind oral solids for FDA?
You see, in China, it's just the workshop without the concrete variety of drug product is certified from Chinese FDA, which is defined as GMP.
Would you like to tell me the difference between cGMP and GMP?
Your kindness will be greatly appriciated.

[Scott Catron]

cGMP (current Good Manufacturing Practice) = GMP. I think 'current' is used just to indicate the newest version of GMP is being used.

As I've said in another thread, the FDA doesn't approve or certify a company's compliance to GMP. They only inspect with the understanding that these inspections are a snapshot of the operations - all their reports stipulate this, so that folks can't go around crowing about how the FDA has 'certified' their quality system.

Now as to operations in China, there is a section at the FDA Drug Registration website that outlines the procedure for registration - look about half-way down the page for "Foreign Establishment Registration". With your registration you will have to assign a United States agent. They may be able to help you with specific questions.

I don't know if the FDA requires an inspection of the facility before product can be imported. I assume it will depend on the product. If an NDA is involved, then I would guess that they would want to inspect. If it's an ANDA or a monographed OTC product, I'm not sure.

[Nancy_Jing]

First of all, thanks very much for your kindness of answering my question. As working in Chinese pharmaceutical company, I meet a lot difficulties in understanding the difference between GMP from the State and that from China. Last Friday, I had a good opportunity to visit a Chinese pharmaceutical company being rebuilt by an American company whose service is to help such Chinese companies get FDA approval for GMP. The result, however, is every disappointing. The problems are as follows for instance: firstly, personnel administration is poor. They allowed the visitors wearing outside coat to go in changing cloth room of the cleaning area. Secondly, about the effective physical isolation of the material, that is the component of the product.

[Ajit Basrur]

Nancy, thats very sorry to note. Btw, are you connected with that organization ?

[Nancy_Jing]

would you like to tell me what 's the meaning of the organization you referred to?

[Ajit Basrur]

Originally Posted by Nancy_Jing

would you like to tell me what 's the meaning of the organization you referred to?

I was referring to the Chinese pharmaceutical company that you mentioned in your earlier post.

[Nancy_Jing]

Originally Posted by Qualityalways

I was referring to the Chinese pharmaceutical company that you mentioned in your earlier post.

Not yet. Because I don't well know about the cGMP standards of the State. That's the reason why I question here.