Documentation
Name one RP at AbbVie
Jason Thatcher
Anna Katorkina
Miriam Khadum
What is the typical temperature range requirements for cold-chain storage for refrigerated medicines?
+2°C to +8°C
Who is the Regulatory Agency in the UK?
MHRA
What does CAPA stand for?
Can RPs delegate their responsibility to other staff?
No, they can delegate their duties but not their responsibility
What is the typical ambient storage temperature range?
15°C to +25°C
What is the unique number printed on a medicine pack used to track a specific lot known as?
Batch/Lot Number
What does RPi stand for?
Responsible Person for Import
What is any temperature reading recorded outside the labelled product specification range known as?
Temperature Excursion
Complete the GDP Golden Rule: If it's not written down...
It didn't happen!
What is the name of the license that the RP is named on?
WDA(H) license
What is the first thing that must be done once a temperature excursion occurs?
It should be quarantined
Escalated/Reported
Buying medicines from an unverified, cheap online seller introduces the risk of what kind of products?
Counterfeit / Falsified
What does ALCOA stand for? Hint: Acronym used in Data Integrity
Attributable
Legible
Contemporaneous
Original
Accurate
What is the difference between RP and RPi?
An RPi (Responsible Person for Import) is a specialised type of RP that is required if a company imports medicines into Great Britain from approved countries
What is the physical study that is performed in warehouses to identify extreme hot and cold spots before placing temperature sensors called?
Temperature Mapping