pharmaceutical quality

Question 1

regulators have a ….. role to ensure ………. studies to comply with ………..

Answer 1

watchdog
animal
GLP

Question 2

drug development will follow

Answer 2

GLP

Question 3

clinical trial will follow

Answer 3

GMP

Question 4

important drug regulators

Answer 4

FDA
EMEA
MHLW

Question 5

Pharmaceutical quality combines

Answer 5

product design

API sourcing

Question 6

measure quality

QC

Answer 6

lab testing materials

Question 7

GLP- regulatory process: 
T....... F.......
S........
submit data 
F....
A

Answer 7

Test Facility
Sponser
FDA
Approve

Question 8

FDA—–> sponser

Answer 8

external audits and inspections of sponser and test facility

Question 9

when approve

Answer 9

no permission to market regulated product denied