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What does a Qualified Person (QP) in Clinical Research do?

What does a Qualified Person (QP) in Clinical Research do? Posted on: 25 Jun 15


What does a Qualified Person (QP) in Clinical Research do?

Also known as
  • Responsible Person (RP)
  • Authorized Person (AP)

What is the Job of a Qualified Person (QP) in Clinical Research:

Qualified person (QP) is a technical term used in European Union pharmaceutical regulation. The Qualified Person (QP) is essential to the safe control of medicines and needs to have extensive training and in-depth critical understanding of all the aspects associated with pharmaceutical manufacturing.

Job Responsibilities of a Qualified Person:

  • Certifies that batches of medicinal products have been manufactured or assembled and checked in compliance with Member State law and in accordance with their Marketing Authorization
  • Certifies batches prior to use in a clinical trial (human medicines only),
  • Certifies batches prior to release for sale and placing on the market (human and veterinary medicinal products)
  • Oversights and certifies the medicinal investigational products (IMP) for use in clinical research trials
  • The Qualified Persons facilitate the smooth transition through the regulatory process for release
  • Provides preparation of Technical and Quality Agreements for all parts of the supply chain
  • Ensures the supply chain is secure and counterfeit materials cannot be introduced in the system
  • Keeps up to date with current regulatory guidance and expectations
  • Proactively advises customers to ensure compliance with GMP requirements

Qualifications/Experience Needed to Start a Career as a Qualified Person

  • License in pharmacy, biology, chemistry or a person with another permitted academic qualification who has several years of experience working in pharmaceutical manufacturing operations, and has passed examinations that attest to his or her knowledge.
  • Knowledge and skills usually gained through their undergraduate education
  • Extensive work based experience
  • Skills and knowledge must be in line with the QP study guide, through the qualified person eligibility assessment process
  • Training courses specifically tailored to help meet the Qualified Person study guide (optional)
  • Communication skills
  • Self-learning capabilities
  • Proactive personality
  • Ability to work well in a team

Career Progression for a Qualified Person

After being added to their professional body’s register of Eligible QPs, Qualified Persons can grow on the post they are hired. Taking on more responsibilities, projects and mastering all regulations are key parts in working their way to the top of the team they are a part of. To ensure motivation and performance, companies offer bonuses and incentives that add up to what is already an attractive salary package.

Mike Wood - Pharmiweb editor

Last updated on: 25/06/2015 10:57:49

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