Inhalation Drug Products in LDPE Containers A Quality (CMC精品分析.pptVIP

* * * * * * * * * * * * * * * * * * * Recommendations Limit the number of unit-dose-vials per pouch, ideally to one LDPE vial per foil-pouch. Minimize the risk of medication error by patients and health care professionals Prevent unnecessary exposure to local environment (When compared to packaging of multi UDVs/Foil-pouch) * Summary Volatile chemicals present in the packaging components and local environment have great potential to permeate through LDPE vials into drug product formulation on storage (time and temperature). Agency’s Analytical Survey and other supportive data have confirmed i