Q&A

Q&A: The Evolving Role Of The Qualified Person

Source: Sharp
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In this Q&A, Ria Rhemrev-Boom, Lead EU Qualified Person (QP) for Sharp, offers insight into how the role of the QP has changed over time, and the additional requirements introduced by the EU in recent good manufacturing practice (GMP) guidelines.

Find answers to the following questions:

  • How has the role of the QP changed over time?
  • What is the desired outcome for the marketing authorization holders (MAHs) and the QP?
  • What are the QP’s responsibilities and how does annex 16 change them?
  • How is innovation challenging QPs?
  • How can we collaborate for a better outcome?

Related article: The Role Of QPs In Meeting The Challenges Of Increasingly Complex Supply Chains

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