pharmaceutical quality Flashcards
1
Q
what does GLP involve?
A
good laboratory practice
- log books
- equipment verification/calibration
- SOPs
2
Q
GCP?
A
good clinical practice
- standards for clinical trials involving humans
3
Q
cGMP?
A
current good manufacturing practice
- guidelines on what to do – not how
4
Q
2 approaches of GMP?
A
quality by testing
quality by design
5
Q
what is quality control?
A
laboratory testing materials with analytical techniques
6
Q
what is quality assurance?
A
documentation review of all aspects of development
7
Q
what is MHRA?
A
regulatory authority of medicines and devices in UK
8
Q
3 major risks?
A
cross contamination
mix-ups
incorrect or false labelling
9
Q
4 steps to manufacturing an API?
A
1) evaluate material requirements
2) scale up
3) verification batches
4) GMP manufacture
