Qualified Persons

Updated Study Guide 2021 and Transition Period

An updated Qualified Person (QP) Study Guide and Guidance Notes are now available. For candidates still in the pre-application stage, applications under the previous version of the Study Guide will be accepted until 2 May 2022.

After 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 FAQ’s.

Registration Process

From the 18 October, the Joint Programmes Board (JPB) are now operating a Registration process. QP application and sponsor forms will now no longer be 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 to [email protected]

Further information regarding the Registration process can be found in the QP Newsletter and the FAQs.

What is a Qualified Person?

A Qualified Person (QP) is responsible for assuring the quality of medicines. That’s why it’s important that QPs are rigorously trained, with an in-depth understanding of pharmaceutical manufacture.

QPs are legally responsible for certifying batches of medicinal products before they’re used in clinical trials or available on the market.

But a QP doesn’t just need expertise in manufacturing practice. They also need to understand the factors that can affect the safety of medicines and supply chains.

Read our latest newsletter for updates on the QP Scheme

Careers as a Qualified Person

QPs often work in pharmaceutical companies. But there are some NHS roles for QPs, too, in departments which hold a manufacturer’s authorisation to create investigational medicinal products.

Resources:

• Guidance Notes for applicants and sponsors
• Registration Form
• Study Guide
• Code of Practice for Qualified Persons
• FAQs

You do not have to attend any additional courses to become a Qualified Person. The Joint Professional Bodies do not accredit or endorse training courses, and it is for you and your sponsor to decide on how to prepare for assessment.

If you are interested in attending a training course a list of providers is available here.

Becoming a Qualified Person

1. Find a sponsor
   Your sponsor will support you during your qualifying experience and training, help prepare for assessment, provide a sponsor’s report on your ability to act as a QP and verify your application form.
2. Submit a registration form
   You should submit a completed copy of the registration form to your professional body to ensure your sponsor, membership level and formal qualifications are suitable. Your QP Officer will provide you with a copy of the full application form once the relevant checks are complete.
3. Gain relevant experience
   You need at least two years of experience in one or more facility authorised to manufacture medicinal products. If you’re a pharmacist, you only need one year.
4. Apply through your professional body
   Your sponsor should agree that you’re ready to apply. Submit the application form, £770 fee, sponsor’s report, and countersigned copies of your certificates.
5. Wait for your initial assessment
   Your QP Officer will confirm your application has been received. Your application will then be assessed by Assessors from your professional body. If it’s satisfactory, you’ll be invited to interview.
6. Attend your interview
   Interviews take place in London. You can find more information in the Guidance Notes. If you pass, you’ll receive a certificate and be added to your professional body’s QP eligibility list.

RPS Qualified Person Eligibility Panel of Assessors

The Royal Pharmaceutical Society, the Royal Society of Biology and Royal Society of Chemistry (the Joint Professional Bodies or JPB) are required by the Medicine and Healthcare products Regulatory Agency and the Veterinary Medicines Directorate to certify individuals as eligible for nomination as a QP. Each professional body has a Panel of Assessors, which includes a Chairperson and Vice-Chairperson.

The Assessor's role includes the review of initial written assessments, preparing for interviews and interviewing candidates. The interview panel for each assessment normally involves an assessor from each of the professional bodies (three Assessors). 

The RPS Assessors also collaborate with the Royal Pharmaceutical Society to raise awareness on the issues relating to the QP role and in providing support for QPs.

Further details on the role of QP Assessor are included in the RPS QP Eligibility Panel of Assessors - Role and Specification.

Time commitment and remuneration

It is estimated that the total time commitment is 4-6 days per year. This usually includes two days for interviews and two meetings/training days.

RPS QP Assessor vacancies, when available, will be advertised on our QP Assessors page.

Governance

The RPS Governance Handbook includes details on the RPS QP Eligibility Panel of Assessors.

The RPS’ panel requirements, including number of assessors, recruitment to the panel and selection of a Chairperson and Vice-chairperson, are in line with QP eligibility assessment processes. Appointments to the panel are notified to the RPS Appointments Committee.

The Human Medicines Regulations and the Veterinary Medicines Regulations make provisions for the activities of each body, including the RPS, in relation to QPs in pharmaceutical manufacturing. Articles 49 and 50 of Directive 2001/83/EC and Articles 53 and 54 of Directive 2001/82/EC define the stringent requirements for QP eligibility.

If an RPS member appeals the assessors’ decision their appeal will be reviewed following the Society’s QP eligibility appeals procedure (further details are available from the RPS QP officer, Professional Support Service).

Admission to the RPS register of eligible QPs is determined by the QP eligibility assessment scheme. The three professional bodies report on admissions to each professional body's register, to the UK Licensing Authorities.

Transition statement (Updated June 2013)

There have been online discussions about Qualified Persons (QPs) via the Royal Pharmaceutical Society's Groups and we wish to address some of the points:  

• The assessment scheme for QP eligibility is jointly administered by the Royal Pharmaceutical Society (the newly formed professional leadership body), the Royal Society of Chemistry (RSC) and the Society of Biology (SB) on behalf of the Medicines and Healthcare products Regulatory Agency and the Veterinary Medicines Directorate
• The General Pharmaceutical Council has no involvement (formal or informal) with the assessment process
• In common with the Royal Society of Chemistry and Society of Biology, the Royal Pharmaceutical Society maintains a list of its members who have met the QP eligibility criteria; the listing includes the names of current members who have obtained their eligibility status via the transitional arrangements or permanent provisions
• Individuals wishing to apply for assessment of QP eligibility should apply to their respective professional body
• To apply via the RPS for assessment of QP eligibility you must be a Member or Fellow or Associate or Pharmaceutical Scientist member of the Royal Pharmaceutical Society
• The Study Guide describes the required practical experience for QP eligibility applications. In the UK, a minimum of one year of required practical experience for pharmacists has been approved. Any individual who is not registered as a pharmacist (or has not been previously registered as a pharmacist) in the UK, who wishes to apply via the RPS for assessment of QP eligibility, should contact the RPS QP officer for advice before applying
• The Royal Pharmaceutical Society is encouraging Qualified Persons to retain their registration with the General Pharmaceutical Council but it is not a mandatory requirement for QPs
• The QP Code of Practice requires individuals to keep their knowledge and experience up to date and maintain records of continuing professional development to confirm suitability to act as a QP
• Suitability to act as a QP is determined by the MHRA/VMD. If a pharmacist who is currently on the eligibility list decides not to register with the GPhC or be a member of the Royal Pharmaceutical Society he/she could potentially be named as a QP on a licence.