Aseptic Flashcards
1
Q
Criteria for defining hazardous drugs
A
One or more of the following criteria, carcinogenicity, Tetratogenicity, reproductive toxicity, organ toxicity at low doses, genotoxicity
2
Q
Optimum temp for pharm fridge
And what’s the aim
A
2-8
5
3
Q
What does mean kinetic temp address
A
Address the cumulated thermal stress
4
Q
When is it not an IMP?
A
Non investigational medicinal product nIMPs
Reconstitution
5
Q
Risk assessment should be specific to
A
The individual pharmacy
The staff working there
Each medicine they make
6
Q
What is risk assessment
A
A careful look at, in ur work, what could cause patient harm
7
Q
In HMR 2012, how many years does a person selling or supplying an unlicensed med has to keep a record for
A
At least 5 years
8
Q
Good pratice for risk control on specials includes
A
Verification of clinical need Quarantine on receipt Inspection of identity Certificate of analysis / conformity Formal recorded approval
