We've put together a fun little quiz for you to test your Qualified Person (QP) knowledge. If you haven't read our previous blog posts on the QP process, Top Clinical Supply QP Questions Asked At The 2017 Sherpa Summer Seminar and PART 2 OF 3: The QP Role and Annex 16, Stability Data, and Audit Reports, you may want to check them out before quizzing yourself.
See the QP quiz below! How many can you answer?
After reading these, don’t forget to download our QP Process Quiz Answer Key to see how many you got right!
- How will Brexit affect clinical supply?
- Is there an active Mutual Recognition Agreement (MRA) between the EU and USA?
- If a site in the US performs packaging and labelling of an investigational medicinal product then ships this product into the EU for a clinical trial, will someone from the EU receiving company want to audit the US packaging site?
- Can clinical trials materials be shipped to an investigator site before QP certification has been given?
- Does the QP routinely review all documentation supporting a batch before certifying it?
- What is meant by the term “eligible” to act as a QP?
- Does a QP need to be a full time, permanent employee at a site?
- What is the difference between the European Union (EU) and European Economic Area (EEA)?
Don’t forget to download our QP Quiz Answer Sheet:
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About Sherpa Clinical Packaging
Sherpa Clinical Packaging provides clinical trial material management services for clinical studies phases I-IV, including packaging, labeling, distribution, storage and returns and destruction services. We manage trial materials for global studies using our cold-chain expertise and our global distribution network among our other offerings. Our agile managerial and operational systems are built to accommodate ever-changing clinical project requirements and fast turnaround times without sacrificing quality. Sherpa’s responsive team leverages its global expertise to identify and execute creative clinical supply solutions for all clients.
About Sue Mann Consultancy Ltd (SMC)
Sue Mann is the founder and Managing Director of Sue Mann Consultancy Ltd. Sue is a very experienced, energetic, highly effective QA professional working in the Pharmaceutical Industry, who over the years has achieved many significant improvements in both quality and compliance through the introduction of sound, pragmatic practices.
SMC Ltd provides advice and support in all areas of Pharmaceutical Quality and GMP, to help organisations operate effective and compliant Quality Management Systems.