GMP certificate


Dear Friends
there are some arguments that pharmaceutical plants can work with out a valid GMP certificate only with a manufacturing License.
Thanking you in advance

(U. Praveen Kumar) #2

actually you question was not clear. see you can able to manufacture the pharmaceuticals with out GMP certificate also with license that plant it won’t come under GMP plant right. when you want to work under GMP defently you have to get the GMP certificate and you have to start the work.

(Helen Crowley) #3

If you are registering a medicine you need to supply a GMP cert together with the Manufacturing License. These are contained in Module 1 of your submission.
If after you have registered your medicine and you want to add an alternative manufacturing site again you need to submit a GMP cert as supporting documentation together with the Manufacturing License.