ISAR Bioscience receives man­u­fac­tur­ing author­isa­tion and GMP Certificate

Planegg, 15 Decem­ber 2023 - ISAR Bioscience has been gran­ted a man­u­fac­tur­ing author­isa­tion in accord­ance with the Ger­man Medi­cines Act (§13 AMG) and a GMP (Good Man­u­fac­tur­ing Prac­tice) cer­ti­fic­a­tion for its facil­ity in Planegg near Munich. The inter­na­tion­ally recog­nized cer­ti­fic­a­tion ensures the high qual­ity of invest­ig­a­tional medi­cinal products over the entire man­u­fac­tur­ing pro­cess, in accord­ance with the cur­rent European Clin­ical tri­als Reg­u­la­tion No 536/2014 and with European GMP guidelines as well as with those of the Inter­na­tional Coun­cil for Har­mon­isa­tion of Tech­nical Require­ments for Phar­ma­ceut­ic­als for Human Use (ICH).

The GMP cer­ti­fic­ate gran­ted by the reg­u­lat­ory author­ity allows ISAR Bioscience to man­u­fac­ture the invest­ig­a­tional medi­cinal products for clin­ical tri­als with imme­di­ate effect and to have them released by the Qual­i­fied Per­son Suz­ana Levacic-Schulz. GMP and man­u­fac­tur­ing stand­ards are inde­pend­ently mon­itored and inspec­ted by the phar­ma­ceut­ical authorities.

This cer­ti­fic­ate is an extraordin­ary mile­stone in the ISAR Bioscience’s his­tory. The way is now clear for the first clin­ical tri­als. With the GMP cer­ti­fic­a­tion, ISAR Bioscience can man­u­fac­ture its own invest­ig­a­tional medi­cinal products and test them for effic­acy in clin­ical trials.