Documentation
What type of document is a set of step-by-step instructions compiled by an organisation to help workers carry out operations?
SOP (Standard Operating Procedure)
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
What does GDP stand for?
Good Distribution Practice
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 name of the license that allows AbbVie to supply and distribute products within the UK?
The WDA(H) License - (Wholesale Distribution Authorisation for Human Medicines)
What is the unique number printed on a medicine pack used to track a specific lot known as?
Batch/Lot Number
What is the primary purpose of Version Control of documents?
Version control ensures that everyone in an organisation accesses the latest, authorised revision of a document. This prevents compliance issues.
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
Where are AbbVie pharmaceutical products stored in the UK?
At a third party logistics provider - warehouse in Birmingham for further distribution to AbbVie UK and NI customers.
Complete the GDP Golden Rule: If it's not written down...
It didn't happen!
What type of document must be initiated before making an intentional, permanent modification to a validated process?
A Change Control / Change Plan
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
What is VLOG?
AbbVie’s European storage and distribution facility based in the Netherlands, from where all products are shipped to the UK’s 3PL.
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
What is FEFO and why is it important?
FEFO stands for First Expired, First Out. It's an inventory management method where products with the earliest expiration dates are shipped first to minimise product waste and financial loss.
Which MHRA reporting system is used to log suspected side effects from medicines, faulty medical devices or fake products?
The Yellow Card Scheme