GMP Facility for multiple product

(Ramesh Rajendran) #1

we got form 29 test licence for one product, we can use the same facility for manufactering other product, will regulatory will licence on the same facility?

(dushyant) #2

FORM 29 for purpose of examination, test or analysis.
FORM 11 to get licence to import drugs for the purpose of the examination,test & analysis .
FORM 12 for application for licence to import drugs for purpose of the equivalence study & retention.
yes, We can use same facility for manufacturing other product too but make sure other product not comes under Betalactum (Cephalosporins, Monobactams, Penems, Carbacephems,Peniciline) & Hormonal products