pharmaceutical quality Flashcards
1
Q
regulators have a ….. role to ensure ………. studies to comply with ………..
A
watchdog
animal
GLP
2
Q
drug development will follow
A
GLP
3
Q
clinical trial will follow
A
GMP
4
Q
important drug regulators
A
FDA
EMEA
MHLW
5
Q
Pharmaceutical quality combines
A
product design
API sourcing
6
Q
measure quality
QC
A
lab testing materials
7
Q
GLP- regulatory process: T....... F....... S........ submit data F.... A
A
Test Facility
Sponser
FDA
Approve
8
Q
FDA—–> sponser
A
external audits and inspections of sponser and test facility
9
Q
when approve
A
no permission to market regulated product denied
