Hello,

My company is evaluating preparation of take-home medication at clinical sites under aseptic conditions. Specifically, a lyophilized IP in a vial would be reconstituted/diluted and then transferred into another container for patients to take home and self-administer over 1 month. The container would be labeled (description, lot, expiry).

Applicable countries: US, APAC and EU

Questions:
#1
Would this activity be considered manufacturing and therefore require GMP compliance?

#2
What key considerations are needed to ensure a regulatory-compliant supply in this scenario?

Appreciate any insights or experience you can share. Thank you!