Drug­mak­ers seek tweaks to ICH guid­ance on con­tin­u­ous man­u­fac­tur­ing

Eli Lil­ly, Gilead, Ther­mo Fish­er and oth­er in­dus­try groups and non­prof­its like BIO and USP are seek­ing some slight changes and more clar­i­ty from the In­ter­na­tion­al Coun­cil of Har­mon­i­sa­tion on its new guid­ance re­lat­ed to con­tin­u­ous man­u­fac­tur­ing.

The guid­ance, known as Q13, fo­cus­es on con­tin­u­ous man­u­fac­tur­ing and its po­ten­tial to low­er man­u­fac­tur­ing costs and re­duce the phys­i­cal foot­print of man­u­fac­tur­ing fa­cil­i­ties com­pared to tra­di­tion­al batch man­u­fac­tur­ing, ac­cord­ing to USP. Con­tin­u­ous man­u­fac­tur­ing al­so may im­prove qual­i­ty con­trol, low­er the vari­abil­i­ty in man­u­fac­tured prod­ucts, and pro­vide en­hanced flex­i­bil­i­ty in pro­duc­tion quan­ti­ty and uti­liza­tion of man­u­fac­tur­ing lines.

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