quality systems in medicines manufacture Flashcards
1
Q
objectives of ICH Q10
A
- achieve product realisation
- establish and maintain a state of control
- facilitate continual improvement
2
Q
4 steps to pharmaceutical quality systems
A
- say what you do
- do what you say
- prove it
- improve it
3
Q
three ICH systems
A
ICH Q10
ICH Q8
ICH Q9
4
Q
what is ICH Q10
A
pharmaceutical quality systems
5
Q
what is ICH Q8
A
pharmaceutical development
6
Q
what is ICH Q9
A
quality risk management
