It's a legal requirement for every manufacturer of pharmaceutical products to have a Qualified Person.
Assuring the quality of medicines requires a thorough understanding of pharmaceutical law and administration, Pharmaceutical Quality Systems (PQS) and Good Manufacturing Practice (GMP). Pharmaceutical manufacturing supply chains are global and an increasingly complex landscape which the QP must be able to skilfully navigate to uphold patient safety.
QPs use their analytical skills to investigate problems in the manufacturing and analysis of medicines. Strength of character is important – a QP must remain unflappable under pressure and demonstrate strong leadership skills when guiding cross-functional teams.
Most QPs are employed in the pharmaceutical industry, but some are employed or contracted to work at licensed NHS (or equivalent) manufacturing sites.
Eligibility for QP status is administered by the Joint Professional Bodies (JPB): the Royal Society of Chemistry, Royal Society of Biology, and Royal Pharmaceutical Society. We do this on behalf of the Medicines and Healthcare products Regulatory Agency (MHRA), and the Veterinary Medicines Directorate (VMD).
Further information on the Qualified Person and the RSC’s requirements for their role, can be found here.
Here is a register of our members who are eligible to act as Qualified Persons.
Why should I apply?
If you want to develop your career in Regulatory Affairs or Quality Assurance, then Qualified Person could be the next step for you.
By becoming a QP you will:
- be legally qualified to certify batches of medicines, a unique role within the pharmaceutical industry
- be included in the register of eligible QP professionals
- elevate your professional credibility and reputation
- broaden your career prospects as QPs are employed in many areas of the pharmaceutical industry, in the NHS, and other industries
Who can apply?
You must have extensive experience in pharmaceutical manufacture, and support from your employer, before applying for QP eligibility. You also need to:
- be a member of the Royal Society of Chemistry (AMRSC, MRSC, FRSC), or the Royal Pharmaceutical Society or the Royal Society of Biology – please check the guidance notes for membership requirements
- meet formal requirements for qualifications and experience
If your degree does not meet the requirements in the guidance notes please contact our QP officer.
Not a member of the RSC? It's easy to join.
What does it cost?
- Category A (permanent provisions) £770
- The annual retention fee is £75 per year, paid with your membership renewal
You can pay your fee by contacting us.
How to apply
Registration Process
The QP application and sponsor forms are not available online to download and will only be provided to candidates who have successfully registered. To register, please complete the Registration Form and submit it via email here.
Further information regarding these updates and what candidates need to do, can be found in the QP Newsletter and the FAQs.
Please read the Guidance Notes and check that you are eligible to apply before going to the next step.
You must apply for QP status through your professional body: the Royal Society of Chemistry (RSC), Royal Pharmaceutical Society (RPS) or the Royal Society of Biology (RSB).
If your degree does not meet the requirements outlined in the guidance notes please contact us.
Make sure you have a sponsor, someone who knows your day-to-day work. They must be a member of either the RSC, RPS or RSB. You'll need to work with them throughout the whole process. Read the Study guide and Guidance notes for applicants and sponsors so that you and your sponsor are clear about what is required.
If you are unable to have a QP as your sponsor, please refer back to the guidance notes or contact us.
Download the registration form for certification of eligibility. Complete this with your sponsor’s guidance and submit it to us via email. After you have successfully registered you will be provided with the application and sponsor forms.
Once you and your sponsor agree you are ready, you can submit your application form, sponsor form and copies of your training certificates to us via email. You'll then be prompted to pay the fee and once this has been done your forms will be reviewed by your professional body and then sent on to assessors.
Help with your application
- Registration form
- JPB Regular Newsletter
- Study Guide – the knowledge and experience that will be assessed
- Guidance Notes for Applicants and Sponsors – eligibility and requirements
- QP Code of Practice
- QP FAQs
Updated Study Guide 2022 and Transition Period
The updated version of the QP Study Guide and Guidance notes are now available. For those candidates still in the pre-application stage, there will be a transition period were applications under the previous version of the Study Guide will be accepted until the 2nd May 2022. Following this, applications will only be accepted if prepared against the latest version of the Study Guide.
Further information regarding these updates and what candidates need to do, can be found in the QP Newsletter and the FAQs.
QP Training Courses
Some educational establishments and commercial providers run courses aiming to equip prospective candidates with the body of knowledge set out in the study guide.
It's not compulsory to take any course, and it is for you and your sponsor to decide on how to prepare for assessment, which may or may not include attendance at formal training courses.
The Royal Society of Chemistry does approve some courses offered for the purposes of professional development, including some that support development of the skills and knowledge required of Qualified Persons.
This list is provided for informational purposes only. Some training course providers are approved by us, but this is for continuous professional development (CPD) only and in no way implies that this course will fulfil the requirements of the Study Guide. Please see our database of training course providers for more details.
- Inspired Pharma Training
- NSF Health Science
- Qualified Person Personalised Programme (Q3P)
- QP Quandary
- RSSL PharmaTraining
Links to the other professional bodies:
The application process and estimated timescales
- Register by downloading a registration form and submitting it to us via email (allow up to 2 weeks).
- Submit your application forms and payment to us via email.
- We review your application and will request further information from you if necessary (allow up to 2 weeks).
- We then send your application to external assessors (allow 4 weeks to review, depending on their workload).
- If necessary, you will be asked to update your application in line with the assessor’s comments, which will then be reviewed again by the assessors.
- If approved by the assessors, you will be invited to interview.
- If doing the remote format, you will be invited to do a technical test with us (1–2 weeks before the interview).
- You will have your interview, which will typically be 1–2 months after you were invited to interview (depending on conflicts of interest and availability this could be longer).
- The outcome is provided on the day.
- Final email confirmation and feedback is provided after the interview (allow 2 weeks).
Maintaining QP status
The annual retention fee is £55 per year, paid with your membership renewal.
We send out a yearly request for voluntary CPD submissions and you will be invited to submit. If you wish to provide a CPD submission, please fill in the CPD Submission Form. For further information about the CPD/ revalidation process, please have a look at our Guidance document or to submit a completed form please contact us.
Become an assessor
Did you know that, as a Qualified Person, you could help others in your community by becoming a volunteer assessor? If you're interested, please contact us.