In new draft guid­ance for man­u­fac­tur­ing in­spec­tions, FDA draws in­spi­ra­tion from pan­dem­ic meth­ods

The FDA pub­lished new man­u­fac­tur­ing guide­lines on Wednes­day de­tail­ing “al­ter­na­tive tools” to as­sess drug man­u­fac­tur­ing fa­cil­i­ties in pend­ing ap­pli­ca­tions.

The guid­ance out­lines meth­ods pre­vi­ous­ly used by the agency dur­ing the Covid-19 pan­dem­ic to ex­am­ine drug man­u­fac­tur­ing fa­cil­i­ties, back when FDA in­spec­tions weren’t pos­si­ble due to lock­downs and so­cial dis­tanc­ing.

Meth­ods used dur­ing the pan­dem­ic in­clud­ed re­quest­ing records di­rect­ly from fa­cil­i­ties, per­form­ing re­mote reg­u­la­to­ry as­sess­ments (RRA) — in­clud­ing dig­i­tal con­fer­ences and screen shar­ing — and re­quest­ing ex­ist­ing in­spec­tion re­ports from trust­ed for­eign reg­u­la­to­ry agen­cies.

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.