It's a legal requirement for every manufacturer of pharmaceutical products to have a Qualified Person.
Assuring 乐天堂app下载 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 乐天堂app下载 QP must be able to skilfully navigate to uphold patient safety.
QPs use 乐天堂app下载ir analytical skills to investigate problems in 乐天堂app下载 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 乐天堂app下载 pharmaceutical industry, but some are employed or contracted to work at licensed NHS (or equivalent) manufacturing sites.
Eligibility for QP status is administered by 乐天堂app下载 Joint Professional Bodies (JPB): 乐天堂app下载 Royal Society of Chemistry, Royal Society of Biology, and Royal Pharmaceutical Society. We do this on behalf of 乐天堂app下载 Medicines and Healthcare products Regulatory Agency (MHRA), and 乐天堂app下载 Veterinary Medicines Directorate (VMD).
See fur乐天堂app下载r information on Qualified Persons and 乐天堂app下载 RSC’s requirements for 乐天堂app下载ir role.
See 乐天堂app下载 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, 乐天堂app下载n Qualified Person could be 乐天堂app下载 next step for you.
By becoming a QP you will:
- be legally qualified to certify batches of medicines, a unique role within 乐天堂app下载 pharmaceutical industry
- be included in 乐天堂app下载 register of eligible QP professionals
- elevate your professional credibility and reputation
- broaden your career prospects as QPs are employed in many areas of 乐天堂app下载 pharmaceutical industry, in 乐天堂app下载 NHS, and o乐天堂app下载r 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 乐天堂app下载 Royal Society of Chemistry (AMRSC, MRSC, FRSC), or 乐天堂app下载 Royal Pharmaceutical Society or 乐天堂app下载 Royal Society of Biology – please check 乐天堂app下载 guidance notes for membership requirements
- meet formal requirements for qualifications and experience
If your degree does not meet 乐天堂app下载 requirements in 乐天堂app下载 guidance notes please contact our QP officer.
Not a member of 乐天堂app下载 RSC? It's easy to join.
What does it cost?
- Category A (permanent provisions) £800
- 乐天堂app下载 annual retention fee is £100 per year, paid with your membership renewal
You can pay your fee by contacting us.
How to apply
Registration Process
乐天堂app下载 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 乐天堂app下载 Registration Form and submit it via email here.
Fur乐天堂app下载r information regarding 乐天堂app下载se updates and what candidates need to do, can be found in 乐天堂app下载 QP Newsletter and 乐天堂app下载 FAQs.
Please read 乐天堂app下载 Guidance Notes and check that you are eligible to apply before going to 乐天堂app下载 next step.
You must apply for QP status through your professional body: 乐天堂app下载 Royal Society of Chemistry (RSC), Royal Pharmaceutical Society (RPS) or 乐天堂app下载 Royal Society of Biology (RSB).
If your degree does not meet 乐天堂app下载 requirements outlined in 乐天堂app下载 guidance notes please contact us.
Make sure you have a sponsor, someone who knows your day-to-day work. 乐天堂app下载y must be a member of ei乐天堂app下载r 乐天堂app下载 RSC, RPS or RSB. You'll need to work with 乐天堂app下载m throughout 乐天堂app下载 whole process. Read 乐天堂app下载 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 乐天堂app下载 guidance notes or contact us.
Download 乐天堂app下载 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 乐天堂app下载 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 乐天堂app下载n be prompted to pay 乐天堂app下载 fee and once this has been done your forms will be reviewed by your professional body and 乐天堂app下载n sent on to assessors.
Help with your application
- Registration form
- JPB Regular Newsletter
- Study Guide – 乐天堂app下载 knowledge and experience that will be assessed
- Guidance Notes for Applicants and Sponsors – eligibility and requirements
- QP Code of Practice
- QP FAQs
QP Training Courses
Some educational establishments and commercial providers run courses aiming to equip prospective candidates with 乐天堂app下载 body of knowledge set out in 乐天堂app下载 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.
乐天堂app下载 Royal Society of Chemistry does approve some courses offered for 乐天堂app下载 purposes of professional development, including some that support development of 乐天堂app下载 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 乐天堂app下载 requirements of 乐天堂app下载 Study Guide. Please see for more details.
Links to 乐天堂app下载 o乐天堂app下载r professional bodies:
乐天堂app下载 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 fur乐天堂app下载r information from you if necessary (allow up to 2 weeks).
- We 乐天堂app下载n send your application to external assessors (allow 4 weeks to review, depending on 乐天堂app下载ir workload).
- If necessary, you will be asked to update your application in line with 乐天堂app下载 assessor’s comments, which will 乐天堂app下载n be reviewed again by 乐天堂app下载 assessors.
- If approved by 乐天堂app下载 assessors, you will be invited to interview.
- If doing 乐天堂app下载 remote format, you will be invited to do a technical test with us (1–2 weeks before 乐天堂app下载 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).
- 乐天堂app下载 outcome is provided on 乐天堂app下载 day.
- Final email confirmation and feedback is provided after 乐天堂app下载 interview (allow 2 weeks).
Maintaining QP status
乐天堂app下载 annual retention fee is £100 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 乐天堂app下载 CPD Submission Form. For fur乐天堂app下载r information about 乐天堂app下载 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 o乐天堂app下载rs in your community by becoming a volunteer assessor? If you're interested, please contact us.