Regarding FDA Certificate

Hello dear
I have 3 years of experience in Pharma Field specially in Microbiology and I wants to know Is there any procedure ( without involvement of company ) to apply for FDA approval Or FDA Approved Microbiologist? Can we directly apply for this ?
Kindly suggest.

According to my understanding an individual can not independently apply for FDA approval (FDA approved Microbiologist) in Maharashtra state FDA. The company management should send your application to state FDA for this purpose (intimation to FDA for certification as "Competent technical staff for supervision of activities in either QC Laboratory or in production areas). The names of “FDA Approved” technical staff appointed in QC Laborartory & Production areas of the company are incorporated in the manufacturing license granted by FDA (Licensing authority).
For other states FDA I am not aware.

This procedure is applicable in our state also.

OK. Thank you.

1 Like