Candidate Guidance

The Road to Becoming a QP

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QPs play a critical role in safeguarding patient safety, product quality, and regulatory compliance.

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A Qualified Person (QP) is a legally responsible professional who certifies that each batch of medicinal products (including investigational medicinal products) has been manufactured and tested in accordance with Good Manufacturing Practice (GMP), relevant marketing authorisations, and other legal requirements.

The Pathway

Eight Steps

01

Education / Qualifications
Hold a relevant undergraduate degree (or equivalent) in a scientific discipline, typically biology, chemistry, pharmaceutical sciences, pharmacy, or a closely related field.
  • Degree must provide a strong foundation in chemistry, biology, microbiology, and related areas
  • Professional bodies evaluate whether qualifications meet the QP Study Guide requirements
  • Gaps identified may need to be addressed through additional study
Tip: Perform a CV gap analysis early to identify any shortfalls in your academic background.

02

Gain Relevant Practical Experience
Accumulate at least 2 years (or 1 year for pharmacists in some cases) of hands-on experience in Quality Control (QC), Quality Assurance (QA), or related roles within a GMP-regulated manufacturing environment.
  • Experience must cover qualitative and quantitative analysis of medicinal products
  • Testing and checking to ensure product quality
  • Broader QA activities in authorised manufacturing facilities (MIA or MIA(IMP))
  • Site visits or purely non-licensed work generally do not count
  • Experience from multiple sites or EU facilities can be considered if relevant
This stage is crucial for developing real-world decision-making skills under regulatory pressure.

03

Secure a Sponsor / Mentor
Identify a suitable sponsor — ideally a practising QP who is a member of one of the JPBs and has known your work for a significant period.
  • Sponsor provides guidance and vouches for your experience and readiness
  • May countersign reports if needed
  • Multiple sponsors may be required if experience spans several employers

04

Professional Membership
Become a member of one of the supporting professional bodies (RSC, RSB, or RPS), choosing the one most aligned with your background.
  • Specific membership grades are often required (e.g. MRSC, AMRSC, depending on the body)

05

Complete Targeted Study and Training
Thoroughly study the QP Study Guide, which outlines the required knowledge across key areas. Training is typically modular and flexible to fit around full-time work.
  • Pharmaceutical Law and Administration (including post-Brexit UK regulations)
  • Pharmaceutical Quality Systems and GMP
  • Pharmaceutical Microbiology
  • Medicinal Chemistry and Therapeutics
  • Pharmaceutical Formulation and Processing
  • Analysis and Testing
  • Biotechnology, ATMPs, and IMPs
  • Active Pharmaceutical Ingredients (APIs)
  • Pharmaceutical Packaging; Mathematics and Statistics
  • Role and Professional Duties of the QP

06

Prepare and Submit Your Application
Compile a detailed application demonstrating how your education, experience, training, and competencies meet the Study Guide requirements.
  • Include evidence of applied knowledge, sponsor reports, and training records
  • Process often starts with a registration step to confirm eligibility
  • Applications are reviewed by the professional body and external assessors

07

Viva (Oral Interview / Assessment)
Successful applications lead to a viva voce lasting approximately 90–120 minutes, sometimes with a technical test.
  • Assessors test depth and breadth of knowledge
  • Critical thinking and decision-making in complex regulatory scenarios
  • Professional judgement, leadership, and integrity
  • Preparation often includes mock interviews, mentor support, and focused revision

08

Nomination and Ongoing Responsibilities

On passing the viva, the professional body nominates you to the MHRA/VMD for final approval. Once eligible, you can be named on a manufacturing licence and begin acting as a QP.

Maintaining QP Status

CPD

Continuing Professional Development must be maintained throughout your career as a QP.

Annual Retention

Annual retention fees are payable to your professional body to remain on the register.

Code of Practice

Adherence to the QP Code of Practice is required at all times.

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