Frequently Asked Questions

1. What advice is given to QP applicants with respect to membership of the Royal Society of Chemistry? 
   Applicants should EITHER be a Chartered Chemist (CChem), OR  a Fellow (FRSC) or Member (MRSC) or Associate Member (AMRSC) who qualified on the basis of a formal course of study lasting not less than three years full-time or equivalent. 

2. Who should act as a sponsor for a potential QP applicant?
   The advice given by the three professional bodies is published in the 'Guidance Notes for Applicants and Sponsors'. The role of the sponsor is important in the QP's training and application for admission to the Register. The expectation is that the sponsor acts as a mentor and supports the applicant throughout the process.

3. Does an applicant's sponsor have to be a Qualified Person?
   The advice of the professional bodies is stated in the 'Guidance Notes for Applicants and Sponsors'.
   Support is required by a sponsor, who must be a member of one of the Joint Professional Bodies (the Institute of Biology, Royal Pharmaceutical Society of Great Britain or Royal Society of Chemistry). The sponsor must be a practising Qualified Person who has known the applicant for the qualifying period of experience required. If this is not possible, an applicant may use a QA line manager provided that the sponsor's report is countersigned by the Qualified Person. More than one sponsor may be required, for example if the applicant's experience has been gained in more than one company.
   In case of difficulty, you should contact the Registration Officer at the RSC for advice.

4. How much detail should an applicant include on the application form for sections 8 and 9 (Foundation knowledge elements and Additional knowledge elements)? 
   You are advised to discuss this with your sponsor.

5. Which products and processes are eligible as your area of expertise? 
   Any, as long as they are licensed under a full manufacturer's authorisation.

6. Can a person apply for QP eligibility if he/she only has experience in a bulk manufacture or research and development environment? 
   Under Article 49 of Directive 2001/83/EC, the relevant practical experience has to be gained in a facility that holds a full manufacturer's licence. As most API (bulk drug) and R & D do not currently (and typically) require a manufacturer's licence, they cannot be used as areas of relevant experience to satisfy the practical experience requirements.

7. Can a person apply with experience of veterinary products?
   Appropriate experience under a licence to manufacture veterinary products (2001/82/EC) enables an applicant to apply for QP eligibility under the permanent provisions.

8. If an applicant has gained broad practical experience across all areas of   the Study Guide, what should he/she choose as the specialist area of expertise? 
   You are advised to discuss this situation with your sponsor.

9. Is the JPB Assessment Panel biased towards an applicant's chosen area of expertise (specific dosage form)?
   Assessors are nominated for membership of the Panel on the basis of their breadth and depth of knowledge and practical experience across the range of products and processes. Most assessors have gained eligibility via the JPB permanent provisions route.

10. An applicant holds a PhD from a UK university. Does this count towards the educational requirements of Article 49 of 2001/83/EC? 
    No, a UK PhD is not admissible under Article 49 of 2001/83/EC. Article 49 requires "the possession of a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course of study". As a PhD is a period of research, and not a taught course, it does not qualify towards fulfilment of this statement.

11. Where can an applicant study the theoretical knowledge requirements for Qualified Persons? 
    Applicants may wish to undertake personal study to satisfy the theoretical knowledge requirements of the Study Guide. A number of academic and commercial companies offer courses. The Joint Professional Bodies do not recommend or endorse particular courses. For information, there is a list of available courses on the RSC website

12. How long does it take for a QP application to be processed? 
    The length of time taken to process an application for nomination to the Register of Qualified Persons is dependent on a number of factors, including the quality of the initial application. Typically the assessment process takes from two to six months. The application is reviewed by two assessors before making the decision whether to invite the applicant for an assessment interview (check at the bottom of the page, and click on the link to view the form used by the assessors to summarise their decision).

13. Is it possible to reserve an assessment slot? 
    An applicant is invited to attend a formal assessment once the application has been reviewed by the assessors. It is not possible to reserve an assessment date in advance. Dates are offered on a first-come first-served basis. However, the JPB try to accommodate applicants' preferences where possible.

14. Can an applicant change the date of the interview, once agreed?
    The applicant should contact the Registration Officer as soon as possible. If an assessment is cancelled at short notice, this can result in inconvenience to other applicants and assessors. If an applicant wishes to cancel an assessment date with less than 6 weeks notice, there will be a cancellation fee of £250, unless there are extenuating circumstances.

15. At the QP interview, who will an applicant's assessors be?
    The JPB do not inform applicants prior to an assessment which assessors will be present. 

16. What is the current pass rate for Qualified Persons assessments? 
    In 2006, the pass rate under the permanent provisions was 78%.

17. What is the JPB's policy on releasing and publishing questions asked at QP assessments? 
    The JPB do not publish lists of questions asked at QP assessments. 

18. What feedback is given to an applicant who does not pass the JPB QP Panel interview? 
    Applicants are told of the outcome of the assessment at the time of assessment. The Panel of Assessors gives direct feedback to the applicants, and applicants are given the opportunity to ask for clarification. Applicants are also given advice on how to progress with training to gain certification as eligible Qualified Persons. Typically, applicants are advised to discuss the matter further with their sponsors and draw up a training plan. Applicants are formally advised of the assessment outcome in a letter from the RSC.

19. An applicant failed his/her oral assessment and is recommended to re-apply in (for example) twelve months time. Is a second application form and fee required?
    Yes, as the second application will be assessed as a new application. As the applicant has gained additional knowledge and practical experience, he/she needs to complete a new application form to reflect this. The same fee is payable for each application.

20. Do the JPB assess members from outside the UK? 
    The JPB will assess an application for Qualified Persons, whether the applicant is resident in the UK, Europe or rest of the world. However, the applicant must fulfil the requirements of Directives 2001/83/EC, 2001/82/EC or 2001/20/EC with respect to his/her qualifications and experience.

21. How can an applicant apply under the transitional provisions?
    The requirements for eligibility under the transitional provisions of the Directives 2001/83/EC are described in the Guidance Notes. Since the changes in legislation relating to veterinary products in 2005, applications can no longer be made under the transitional provisions of 2001/82/EC. Prospective applicants should contact the VMD for advice.

22. How can a QP eligible under the transitional provisions of the Clinical Trials Directive 2001/20/EC apply for an entry on the Register? 
    The new QPs required under this directive are eligible to be certificated by the Professional Bodies and to have an entry in the RSC Register of Eligible Qualified Persons. Those eligible for certification will be RSC members. They will have been named as a Qualified Person in an application for a clinical trials manufacturing authorisation made prior to 1 May 2006, and have been accepted to act as a QP for investigational medicinal products by the MHRA and named on the clinical trials manufacturing authorisation. Certification by a professional body is not essential in these circumstances, but such persons are nevertheless eligible for certification and are advised, in any event, to retain details of the licence(s) on which they were named. Please refer to the Guidance Notes.
    Applicants with at least 2 years experience under a manufacturers licence issued under Directive 2001/20/EC are eligible to apply under Category A. 
    Please refer to the Guidance Notes.

23. What is the RSC's policy for charging retention fees to remain on the Register?  
    All members listed in the Register are required to pay an annual retention fee of £25 per year. This payment is requested at the same time as the membership subscriptions. If a member does not pay the retention fee, he/she will not be listed in the Register. 

24. Does the RSC publish information on QP salaries and statistics? 
    The RSC produces a biannual remuneration survey that lists information about QP salaries. This publication may be obtained from the RSC's Professional Services Department at Burlington House or from the members' section of the RSC website

25. How does the RSC CPD scheme work for QP registrants? 
    The RSC has a CPD structure for members from when they join as undergraduates throughout their careers. There is a section relating to QPs. Details are available in the CPD area of the RSC website. 

26. How many QPs are registered with the RSC? 
    In 2006 there were 683 QPs registered. This includes 273 registrants who qualified via the permanent provisions.