QUALIFIED PERSONS

The Qualified Person (QP) is essential to the safe control of medicines and needs to have extensive training and in-depth critical understanding of all the aspects associated with pharmaceutical manufacturing.

The primary legal responsibility of the QP is to certify batches of medicinal products prior to use in a clinical trial (human medicines products only) or prior to release for sale and placing on the market (human and veterinary medicinal products).

In the UK the Medicines and Healthcare products Regulatory Agency (MHRA) and Veterinary Medicines Directorate (MHRA) have delegated responsibility for certification of eligibility for nomination as a QP to three professional bodies: the Royal Pharmaceutical Society (RPS), Royal Society of Biology (RSB) and Royal Society of Chemistry (RSC) (the 'Joint Professional Bodies'). View Joint Professional Bodies Qualified Persons' eligibility scheme.

Career as a Qualified Person

The Qualified Person (QP) has a responsibility to certify the quality of medicines before they are released onto the market or for use in a clinical trial and this is defined in EU law. Each manufacturer of human or veterinary medicinal products requires a QP(s) who is named on the manufacturer’s authorisation.

The responsibilities of the QP are wider than their obligations relating to certification of products and batch release. The QP has expertise in good manufacturing practice but is also required to have a good understanding of all aspects of the medicines manufacturing and supply chain.

Although QP roles are most common in pharmaceutical companies, there are other settings where this expertise is required — for instance, some NHS pharmacy departments hold a manufacturer’s authorisation (eg, to manufacture investigational medicinal products) and so are required to appoint a QP.

View articles on how to become a QP and QP careers:

The following selection of case studies have been gathered to describe the career path of pharmacists who have chosen to become QPs. Our contributors describe the triggers that influenced their decision to become a QP and their experiences of achieving QP status. We are collating case studies for our website to describe the varied roles of QPs. If you are an RPS member and QP who would like to be a case study, please contact RPS Professional Support Service.

A QP online group has been set up for all members interested in QPs, including anyone interested in becoming a QP and members listed on the RPS register of eligible QPs.

View our additional resources section if you are interested in other careers in pharmaceutical manufacturing. In addition, some individuals who are eligible to become a QP work in other areas eg, training, consultancy, regulatory authorities. There are many careers in the pharmaceutical industry, clinical research and the NHS that are suitable for pharmacists and pharmaceutical scientists.

Case Study 1: Becoming eligible for nomination as a QP – View his case study Case Study 1: Becoming eligible for nomination as a QP – View his case study

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john

John Horry

I am a 48-year-old married man, with three (expensive!) teenage children and I live in the East Midlands. I have worked in the pharmaceutical industry for 26 years after completing my pre-registration training in community pharmacy. My career has covered many different areas including: technical development, operations management, business development, strategic review, international supply chain management, project management and quality compliance. I have worked at most levels in various organisations - from the shop floor to the board room.


Why did you decide to become a QP?

Quality is an area that I have always had a personal interest in. This interest was increased through working with sterile products and being involved in developing quality systems for a new factory. For a number of years my career took me into senior strategic and operational roles where I worked with the Quality Organisation to implement suitable systems and procedures. I was thoroughly aware of the changes in legislation and the growing importance of the QP role. Following company acquisition, the opportunity arose to move into the Quality Department and train as a QP. Given my previous interest and experience I jumped at the chance! It also seems a very natural role for a pharmacist as it makes use of the wide understanding that a pharmacist has across all disciplines of drug, development, manufacture, distribution and use.


How did you achieve QP eligibility status?

Via the permanent provision (category A). I recently passed the QP assessment.


How did you prepare for your viva?

To prepare myself for the viva I conducted a “gap” analysis against the study guide requirements and tailored a training programme for myself. This consisted of a number of courses (provided by more than one training provider) and a significant level of personal study. It took just over 12 months to be in a position to submit my application form.

My sponsor was very helpful in pointing me in the right direction and as I got close to the viva date he organised a number of mock vivas for me. Looking back, the process was challenging but immensely enjoyable and rewarding.

I must mention that my employers, Reckitt Benckiser Healthcare, have been extremely supportive of my training programme. Not only have they covered my training course expenses but individuals have generously given their time to help and support me.


What is your current job?

I am currently employed by Reckitt Benckiser Healthcare as a Global Quality/Compliance Manager primarily responsible for the development and deployment of quality policy across the company. I set in place global policies and procedures and train others in these policies and procedures.

This covers all aspects of the company’s healthcare operations across the world. To have QP knowledge is immensely valuable, both in terms of personal understanding and credibility. I also work at a local level linked to a specific factory where I intend to operate as a QP routinely certifying batches for release - once my name is added to the Manufacturer’s/Importer’s Authorisation (MIA) that is. This already involves me in many aspects of the factory operation both dealing with problems and, more importantly, implementing solutions and continuous improvement initiatives.


How has this added to your personal development? Was it worth it?

Absolutely! As a curriculum of study it reminded me of much that I had forgotten and brought me up to date as well as covering aspects that I had never encountered before. Having the viva as a target provided the impetus and motivation for the necessary study.

I now feel well prepared for the role as a QP. It has also provided me with very useful content for my CPD return!


Would you recommend this career option to other pharmacists, and why?

Yes definitely as it covers so much of the pharmacist’s traditional role of providing quality dosage forms. The course of study can be tailored to your own needs but is specific enough to give real direction and purpose to that study. The base of knowledge acquired is applicable in many roles within the industry – not only the QP role. As a QP though there is growing opportunity to influence and contribute to the future success of the pharmaceutical industry. New legislation is very likely to widen QP responsibilities across the supply chain and the demand for QPs across Europe will only increase. As a role it is challenging but rewarding (in every sense of the word!).

Case Study 2: A QP in the pharmaceutical industry – View his case study Case Study 2: A QP in the pharmaceutical industry – View his case study

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nick

Nick Hill

I am a married man living in Oxfordshire. I obtained my pharmacy degree from Bath University in mid-80s with did my pre-registration training at the Oxford teaching hospitals. I have worked in the UK pharmaceutical industry for 23 years in a variety of technical/operational positions with responsibility for production, QA, QC, regulatory, validation and general management. I have worked with a variety of dosage forms-tablets/ capsules, liquids/creams, small volume aseptic products, biologics, blood products and clinical trial manufacture.

I have been a QP assessor for five years, which involves assessing prospective QP candidates with assessors from the other professional bodies through the application form and viva process.


Why did you decide to become a QP?

Working in a pharmaceutical production environment is something I have enjoyed. Being a QP provides me with an opportunity to work with many different functions – production, QA, QC, validation, engineering, logistics, marketing, safety, medical. My job requires me to make challenging decisions balancing patient safety, GMP, legal considerations.

I wanted a recognised qualification in pharmaceutical operations and feel that training to become a QP is an excellent foundation for any leadership role in pharmaceutical operations.

Whilst in the UK, the pharmaceutical production sector is not increasing, the need for QPs will continue as a product needs to be QP released into the EU.


How did you achieve QP eligibility status?

Via the permanent provisions (category A) in the late 1990s.


How did you prepare for your viva?

Being a pharmacist, I had already learned much of the QP study guide knowledge requirements. Combined with 10-plus years of practical experience, I only needed to attend three knowledge modules from a training provider.

This was agreed between my company sponsor, David Begg Associates (DBA) and myself after a detailed discussion on my education and experience against the QP study guide. From a practical experience viewpoint, I agreed with my sponsor some additional practical laboratory and laboratory management experience.

I had a number of practice vivas with my sponsor and with DBA.

As a pharmacist in pharmaceutical operations, becoming a QP can be an easier path than for chemists and biologists.


What is your current job?

As a Qualified Person, I have had responsibility for QA and product release in classical aseptic products, blood products and biologics.

I now work for Allergan UK based in Marlow. My company manufactures and sells botulinum toxin, ophthalmology products and a range of medical devices. I am responsible for quality for commercial distributed product in the European region.

Being a QP helps me when working with quality colleagues in our manufacturing plants in Europe and in the US.

I am named as a Qualified Person on our clinical trial manufacturing licence for the Marlow site. Aside from product release activities, I am involved in audits of manufacturing sites for GMP compliance and a wide range of Quality Management activities. I also have responsibility for regulatory for medical devices and some pharmaceutical markets.


How has this added to your personal development? Was it worth it?

Being a Qualified Person is a natural step for a pharmacist working in the industry. The training and “permanent provisions” QP eligibility is well understood within the industry and recognises you as someone who has a strong knowledge and experience in pharmaceutical quality. Qualified Persons are often in short supply and job opportunities for QPs are good and can be well paid. The QP experience is a good step towards further development within senior management in a company.


Would you recommend this career option to other pharmacists, and why?

Definitely. As a pharmacist, it uses and develops the knowledge we gain from a pharmacy degree. Patient safety is fundamental to the QP role. The role is very varied, challenging and an excellent career path for pharmacists.

Case Study 3: QP knowledge is useful for a variety of roles – View her case study Case Study 3: QP knowledge is useful for a variety of roles – View her case study

Personal profile

I am female, 48 years old, living in Hertfordshire.


My career history is:

Head of Quality NIBSC – Feb 08 to current
Quality Manager NIBSC – Aug 06 to  Feb 08
Cell Biology QA Manager for UKSCB, NIBSC – Nov 04 to Aug 06
Operations Director Generics [UK] Ltd – Feb 02  to Nov 04 
Head of Quality Operations Generics [UK] Ltd – Jul 00 to Feb 02 
Head of Compliance & Technical Services Generics [UK] Ltd – Sep 91 to Jul 00 
Registration Officer –  Dec 90 to Sept 91
Purchasing Control and Supplies Officer BAOR, HM Forces – Aug 89 to Dec 90
Pharmacist / Medical Supply Officer, HM Forces – Nov 86 to Aug 89
Boots the Chemist Ltd, Relief Manager – Jul 86 to Nov 86 
Boots the Chemist Ltd, Pre-registration placement – Jul 85 to Jul 86

I became a QP whilst working at Generics [UK]. In my role as Head of Quality Operations at Generics UK I was responsible for all QA and QC matters for  the UK site and European Compliance and Stability issues (department of 90 Staff) including acting as releasing QP for complete product range but primarily for the non-routine or problem products (ie sterile and 3rd party manufactured products).

I used the knowledge that I gained as a QP when I was promoted to Operations Director. To allow me to spend more time at home I then went for a career change and went for a position with no line management responsibility and much less pressurised. As Cell Biology QA Manager at the National Institute for Biological Standards and Control (NIBSC) I was working in a field that was totally new to me, but the knowledge I had gained as a QP allowed me to develop their quality management system (QMS). Due to staff changes, the position of Quality Manager for the Institute arose and I took on the challenge.  The Head of Quality retired in early 2008 and I was appointed to his position.


Why did you decide to become a QP?

Career progression.


How did you achieve QP eligibility status?

Via the permanent provision (category A). I studied for an MSc at Brighton University and my practical experience was gained at Generics [UK] and sister sites.


What is your current job?

I am Head of Quality for the National Institute for Biological Standards and Control (NIBSC). NIBSC is the global leader in the field of biological standardisation, responsible for developing and producing over 90% of the International Standards in use around the world to assure the quality of biological medicines. The Institute is the UK's Official Medicines Control Laboratory (OMCL), responsible for testing of biological medicines within the framework of the European Union. The Institute has a particularly close relationship with the World Health Organisation (WHO) and is the leading WHO International Laboratory for Standards.

NIBSC is a centre of the UK Health Protection Agency (HPA).

My role enables me to influence the strategic direction that the Quality function should take at NIBSC and wider in the HPA.

At the same time I am UK Stem Cell Bank (UKSCB) Quality Manager and so have been heavily involved in the development of the UKSCB QMS for Clinical Grade Stem Cells.  My knowledge as a QP has allowed me to review the requirements of the HTA Codes of Practice and EUTCD and build on my GMP experiences to develop a QMS that meets the needs to all these systems, but is not onerous for the Scientists.

In my previous position of Quality Manager for the Institute I was responsible for all the Institutes QMS (ISO 17025, ISO 9001 and ISO 13485).  The main challenge for this post was to persuading sceptical Scientists that a Quality Management System can add value.  The knowledge gained as a QP in a commercial setting allowed me to be quite ‘bullish’ about what was required and we stripped out a lot of unnecessary bureaucracy.

As Cell Biology QA Manager I was working in a field that was totally new to me, I developed their QMS into a more embedded system so that the Scientists saw quality as part of their daily work.  I was also involved in developing the QMS to meet the new HTA (Human Tissue Authority) requirements as well as carrying out batch release of GMP qualified cell lines.

In my previous role as Operations Director at Generics [UK] the knowledge I gained as a QP enabled me to:

  • Initiate a project to shrink the end-to-end lead time from suppliers of active and bulk tablets to allow for reduction in stock holding without compromising the quality management system
  • Decrease line change over times thus increasing line output with no increase in resource resulting in a 50% reduction in the cost per pack
  • Co-ordinate product transfers to other sites ensuring that the processes and analytical methods were appropriately transferred and validated and the site met GMP
  • Management of quality functions for new product introductions manufactured at 3rd party sites to allow for the product to be released for sale on the first day of patent expiry
  • Develop and rolled out training programme for cGMP, management and QP training

How has this added to your personal development? Was it worth it?

I no longer see myself as a Pharmacist but as a Quality Expert with QP status. My knowledge as a QP has enabled me to work in a variety of roles.


Would you recommend this career option to other pharmacists, and why?

Yes – by having a pharmacy degree it has opened doors and given a good foundation of knowledge that you can then apply to different situations.

Case Study 4: The QP role is an ideal career for a pharmacist – View her case study Case Study 4: The QP role is an ideal career for a pharmacist – View her case study

Personal Profile

soniabradford

Sonia Bradford

I am 41 years old, live in Cambridgeshire and  married with 2 young boys who keep me very busy! After getting my pharmacy degree from Nottingham university, I did my pre-registration training at Addenbrookes hospital in Cambridge. Since then I have worked for the last 20 years within the pharmaceutical industry. I have had roles within formulation and development, manufacturing QA, validation, and for the last 10 years I’ve been working in the  Research QA/ clinical trial arena where I’ve also had roles in relation to GCP and Pharmacovigilance activities.


Why did you decide to become a QP?

I must admit that when I moved from Formulation and Development into the Quality world nearly 15 years ago, being a QP was not top of my career agenda mainly because I did not know much about the role. However, when my company asked if I would like to undertake the training, I didn’t hesitate in grabbing the opportunity. It seemed that a pharmacist is ideally suited to the role as much of our training background is around the drug / product development process. The training also enabled me to gain a greater understanding of many different areas of the business. Becoming a QP also provides you with a qualification within industry which is always going to be of value – no pharmaceutical company can operate without QPs named on their licence!


How did you achieve QP eligibility status?

When I started down the route of becoming a QP under the permanent provisions, I was relatively new to industry. Hence, I did attend the majority of the knowledge modules from the training provider David Begg Associates. However, these courses do more than just provide lecture notes as they are constantly referring to practical situations/ examples which QPs can come across. I found them extremely beneficial. I also worked with my sponsor to identify gaps in my practical experience which mainly were around sterile manufacture activities. Hence from various external contacts, I was able to spend a few weeks within this area

Having achieved enough practical experience to be able to fill in the detailed application form, many fun filled hours were spent at home revising!  Then there was the mock viva with DBA. I think I was more nervous for this than the real thing since my sponsor/boss was present! However, it did prepare me well and gave me confidence for the real thing so would recommend going through the additional challenge.


What is your current job?

I am currently employed by Napp Pharmaceuticals. Having obtained QP status, I initially worked in the production areas having responsibility for QP release of solid dose preparations. I then took on role of Research QA Manager and had responsibility for clinical trial QP release. Within this role, I also had management responsibility for GCP QA and Pharmacovigilance QA activities.

Having now got 2 young children at home, one of the most important considerations in my job is getting the right work/ life balance and you can achieve this even working as a QP!  Napp has been very flexible and we have developed a role which fits in with my childcare needs. So I now work part-time as a Consultant QP supporting the Clinical Trial group on key projects , being named as a Qualified person on both our clinical trial and production licences.

 


How has this added to your personal development? Was it worth it?

All the training which you need to go through certainly contributes to your personal development and CPD!  It enables you to gain so much more experience of different areas of the business. It also means you end up with a recognised qualification within industry and QPs are always going to be in demand. The experience and knowledge base which comes from achieving QP eligibility means that there are usually good career progressions within senior management for QPs.


Would you recommend this career option to other pharmacists, and why?

One of the main challenges is initially getting pharmacists into industry!  But once there, the QP role presents an ideal career option for any pharmacist.  We cover so much of the fundamentals of formulation/ medicinal chemistry/ analysis/ drug development in our pharmacy degree that a lot of the time it is putting this knowledge into practical real life scenarios that occur within industry.  The role is obviously challenging and responsible, but that is what any pharmacist trains for!

Case Study 5: A QP role in clinical research - View his case study Case Study 5: A QP role in clinical research - View his case study

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jonathan-bradshaw

Jonathan Bradshaw

I moved into my current role in clinical research 4 years ago and have recently passed my QP eligibility assessment.

Previously I had worked as a community pharmacy manager with Tesco for 5 years based in London.

Prior to my move to London I worked as a locum and in clinical research and so was familiar with this sector of the industry. Luckily on my return to Northern Ireland a position became available in the clinical research organisation I previously worked for. As I had enjoyed my previous role I applied immediately and was successful in my application. 

I am 37 years old and married with two daughters.


Why did you decide to become a QP?

I enjoy my role in clinical research and wanted to broaden my knowledge and experience in this niche area. I also wanted to challenge myself, develop my skills further and meet with like minded professionals from different disciplines (pharmacists, chemists and biologists).


How did you achieve QP eligibility status?

Via the permanent provisions (category A).


How did you prepare for your viva?

I prepared for QP assessment by undertaking further study and by using both my current role and visits to other companies to gain the necessary experience. Pharmacists need to have worked in a licensed manufacturing facility for at least one year prior to being considered for viva (for biologists and chemists it is two years).

I studied the entire study guide with David Begg Associates (DBA). This consisted of 12 residential modules in York/ Glasgow and Cork with the majority in York. I also attended some addition courses e.g. Pharmaceutical Quality Group meetings to supplement the education gained with DBA. I found it useful to talk through scenarios with other trainee QPs and share experiences from our different roles. This developed the breadth of knowledge required and ensured my decision making process is robust and proportionate.

My sponsor was responsive and very helpful. I would like to thank him and my company, Celerion, for the support they provided. It was very useful to talk scenarios through with my sponsor and he also tested me on my knowledge and the decision making process.

It is a good idea to start the application form as soon as possible and to document your experience as you go through the process.


What is your current job?

My role is in clinical trials within Celerion, a clinical research organisation, where Good Manufacturing Practice and Good Clinical Practice work in tandem. This area is unique and different from traditional manufacture in a lot of ways but is challenging and rewarding.

I have recently applied to be listed as QP under our site licence. Once this is in place my role will shift from being actively involved in the production/ manufacturing process to being the person responsible for the oversight of the production process to ensure the Investigational Medicinal Products are manufactured to ensure quality and efficacy and ultimately safety of our volunteers.

I will be responsible for the legal duties of the QP in addition to ensuring the routine duties are being performed appropriately either by me or by my colleagues. I will work to the QP code of practice and be responsible for annual CPD.


How has this added to your personal development? Was it worth it?

I am continuously learning and developing skills, as all pharmacists do. I found completing the QP course very rewarding indeed. It has been the highlight of my career to date.


Would you recommend this career option to other pharmacists?

Absolutely

Case Study 6: A hospital pharmacist describes preparing for QP viva - View his case study Case Study 6: A hospital pharmacist describes preparing for QP viva - View his case study

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eric-che

Eric Che

After graduating from the University of Nottingham, I spent my pre-registration year at Epsom and St Helier University hospital in Surrey. Since then I have been working in the NHS for the past eight years.

My current role is Quality Assurance Manager at St George’s Healthcare NHS Trust.

I am 32 and live in Surrey. The latest addition of our family came in the same week of my viva day to celebrate my viva results.


How did you achieve QP eligibility status?

Via the permanent provision (category A).


How did you prepare for your viva?

I recently passed the QP eligibility viva and my journey to successfully completing my assessment is described:-

The combination of academic training and clinical experience as a junior pharmacist gave me an understanding of a number of aspects in the Qualified Person study guide.

I have also worked in several MHRA 'Specials' licensed NHS manufacturing units. Although experience in specials manufacturing is not eligible for the practical experience criteria for QP application, it contributed to my practical understanding of good manufacturing practice (GMP) and quality assurance (QA).

The eligible practical experience of my QP application has been accrued as the Head of Quality Control on the manufacturer’s authorisation for investigational medicinal products [MIA (IMP)] licence at St George’s Hospital over the last three years. This role has given me the opportunity to shadow and learn from the IMP QP as well as carrying out the duties of the Quality Controller in IMP manufacturing.

Another aspect of my role at St George’s Hospital is to manage and maintain a contracted QA/QC service to a number of NHS and non-NHS manufacturing units. I am also named as the Quality Controller at three other manfacturer’s specials (MS) licensed units. The experience and exposure that I have gained has been immense.  During the last three years, I hosted nine MHRA inspections at five different sites covering aseptic, non-sterile and repackaging activities.  During the same period, I have also planned and delivered many interesting validation projects including commissioning of aseptic units, computer systems and other equipment. These experiences have helped me enormously in preparing for the QP viva.


Preparation for the QP viva

Preparation started almost two years prior to my viva date. A thorough 360 degree gap analysis was carried out jointly with my sponsor to identify knowledge and experience gaps.

At the time I was about to complete a post graduate diploma in Pharmaceutical Technology and Quality Assurance (PTQA). The course has been developed jointly by the University of Leeds and the NHS. The course has given me solid and sound foundation knowledge in GMP and QA.  On top of PTQA, I have used two training providers to further my knowledge to fulfil the requirement of the study guide - RSSL and Q3P. Q3P is a joint collaboration between the NHS and London School of Pharmacy aimed to address shortage of QPs in the NHS.

Apart from addressing knowledge gaps, there are also several experience gaps that I needed to address.  Through various contacts and networks, I have made visits to a number of UK manufacturing sites covering a range of dosage forms. These visits were immensely valuable in my learning. They have helped me to appreciate and understand the complexity, challenges and interfaces in commercial manufacturing.

In addition to external site visits, I also ensured that I would maximise every opportunity within my workplace to add to my experience. I have spent time in the onsite QC lab to gain hands on experience in both microbiology and chemistry testing.

My support network has been instrumental in my QP application process. There are many fellow QP trainees who gave up their valuable time to support me in mock viva and question/answer sessions.

I had also identified the need to address viva technique.  In my work place, we have limited experience with the viva process, so I have used QP Quandary as part of the viva preparation. Through the coaching sessions and viva practice, I have developed a mnemonic approach to viva scenarios. This is an extremely useful technique which provided me with all the reference points required to navigate through viva scenarios in a logical fashion under pressure.

Another part of the preparation process was practising and recording my practice viva answers on the web cam. Post mortem self analysis of the practice session was inspirational.

I am very fortunate to have an understanding employer who had given me the financial support as well as flexibility to balance work demand and QP viva preparation.

The final piece of viva preparation is my personal commitment and dedication. Throughout the last two years or so, I have made many difficult decisions in my social life in order to accumulate adequate number of hours to give me the confidence in going forward with the QP application.


Would you recommend applying for assessment of QP eligibility to other pharmacists, and why?

Going through the QP application and viva process is certainly a significant commitment both from the work place and also time outside work. It has been a difficult and challenging journey; however, the satisfaction that came with passing the viva is definitely worth it.

Case Study 7: Becoming a QP for the NHS - View her case study Case Study 7: Becoming a QP for the NHS - View her case study

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attia-hasnain-qp-case-study-photo(1)

Attia Hasnain

I am a mother of two children who are currently studying at University; alas neither is studying to become a Pharmacist, choosing Medicine and Dentistry instead. I live in London where I have resided since migrating from Pakistan as a young child with my parents.

I completed my pre-registration training at the Royal London Hospital and thereafter moved to St Thomas’ hospital as a basic grade Pharmacist for a year before going on to do my PhD in Pharmaceutics at the School of Pharmacy, University of London. Immediately after having completed my PhD I went to work in R&D at Aventis Pharma. I immensely enjoyed the 13 years I spent there meeting and making some wonderful friends along the way, with a special mention and thanks to Dr Mike Bowker who was my last Manager and mentor at Aventis Pharma. It was during the latter part of my time at Aventis Pharma that I started the Brighton University MSc QP course. Unfortunately, I was unable to complete my QP training as the R&D site closed in 2000.I left having worked my way up from Unit Head to Department Director during my time there. After a brief stint in Community Pharmacy, (which reinforced it was not right for me), I completed the circle and returned to my roots at the Royal London Hospital which by then had merged with St Barts Hospital although some familiar faces were still there! I spent the first three years there as Principal Pharmacist, Training and Development with the lovely Maggie Oliver as my Manager before moving to my current post of QA Manager.


Why did you decide to become a QP?

Whilst at Aventis Pharma, I became increasingly interested in the quality of medicines we produced and wanted to know who in the company was personally responsible for ensuring their safety, quality and control before they could be sent out for use by patients. In other words, I wanted to know who was working on behalf of the patient. This interest led me to discover the importance of the role and responsibilities of the QP which is when I decided I wanted to become a QP. Furthermore, as a Pharmacist I felt my degree and background would help enormously in achieving this goal.

As QA Manager at Barts Health NHS Trust when I was given the opportunity of pursuing my ambition to become a QP, I jumped at it! I am grateful to Mike Lillywhite who had confidence in me and secured the funding – not an easy thing to do in the NHS!


How did you achieve QP eligibility status?

Via the permanent provisions – category A having passed my QP viva on March 19th 2013.


How did you prepare for your viva?

As a Pharmacist I was already somewhat prepared. In order to identify what I needed to do I carried out a gap analysis against the knowledge requirements of the QP Study Guide. This was an extremely helpful exercise because it made it a lot easier for me to determine how my learning needs could be fulfilled. Based on this I decided to undertake some modules with David Begg Associates and also to attend, as part of the first cohort of students, the Q3P course. The latter is provided by the School of Pharmacy in collaboration with the NHS and was initiated in 2011 to help train and provide more QPs for the NHS in order to overcome their shortage. The course has developed and improved significantly since 2011. I completed the course using my annual leave and found the modules to be particularly good as they provided useful refresher training for me. The course presenters, including Sue Mann, Tony Frost and Alex Hall, were all extremely knowledgeable and supportive. I am most grateful to Sue and Tony who gave up their valuable personal time to help review my application form, for their advice and guidance throughout and for carrying out my mock viva. I would also like to thank Martindale Pharma and colleagues for allowing me to visit their sterile manufacturing facility, to see and learn about their Quality Management system.

Apart from attending the course modules, I was fortunate to have very supportive QP Trainee colleagues who helped me enormously to prepare for the viva by carrying out mock viva sessions with me and regularly checked my knowledge through questions. I was also given a practice viva with DBA which boosted my confidence. My family’s support was invaluable and without the sacrifices they made and their continuous encouragement it would not have been possible for me to qualify as a QP.

Hard work, sacrifices, commitment and prayers, are the words, amongst others, that spring to mind when I think of how I prepared for my viva!


How do you use your QP status in your job?

I have recently applied for my name to be added to the Barts Health NHS MIA (IMP) licence and am awaiting this. I hope to be able to use my QP status for IMPs shortly. As QA Manager I am now also better prepared and equipped to carry out my job in supporting the Manufacturing unit at Barts Health NHS Trust where planned and acute Parenteral Nutrition, CIVAS, aseptic and non-sterile manufacturing occurs. The Unit manufactures for over 130 other Hospital Trusts throughout the UK and Southern Ireland.


How has this added to your personal development? Was it worth it?

Most definitely worth it!  As a QP I feel I have the opportunity to use my experience and knowledge to the full and this is very satisfying.


Would you recommend this career option to other pharmacists, and why?

Certainly. As Pharmacists we are trained through our Pharmacy degree to always think of patients first and have their safety and well being at the heart of all that we do. Becoming a QP to me is therefore a natural extension of our training and just completes and polishes it off.


Steps to achieve QP eligibility status - UK Joint Professional Bodies' scheme 

(Category A route - 'permanent provisions')

Membership of RPS, RSB, or RSC with an acceptable, relevant qualification (Directives 2001/83/EC and 2001/82/EC). Refer to the Application Documents.





Joint Professional Bodies Qualified Persons' eligibility scheme

In the UK the Medicines and Healthcare products Regulatory Agency (MHRA) and the Veterinary Medicines Directorate (VMD) require the Joint Professional Bodies (JPB) to certify the eligibility of their members for nomination as a QP. Members apply via their own professional body (RPS/RSB/RSC).

The MHRA / VMD are responsible for determining who can be named as a QP on a Manufacturer's Authorisation. 

Application Documents

Please refer to the following Application Documents when making an application for certification as a Qualified Person. Members apply via the relevant professional body (RPS/RSB/RSC):

The fee for all applications under the Permanent Provisions (category A) is £600.


The MHRA has issued information for Transitional IMP QPs (named as a QP in a valid application for a manufacturing authorisation for Investigational Medicinal Products (IMPs) made prior to 1st May 2006 under the Medicines for Human Use (Clinical Trials) Regulations 2004). Further details are available on the MHRA website.


FAQs

Additional information is in our Frequently asked questions

If further information is required, applicants should contact the officer at their respective professional body. For information relevant to members of the Royal Pharmaceutical Society please choose from these options:

For general QP enquiries

Complete the online enquiry form (members only).
Email our Professional Support Service: [email protected]
Telephone: 0845 257 2570 (or 020 7572 2737)

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 is not compulsory to take any course, and the Joint Professional Bodies do not accredit or endorse training courses. 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.

A list of training course providers is provided for information only.


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 (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 Qualified Person (QP). Each professional body has a Panel of Assessors which includes a Chairperson and Vice-Chairperson.

The Royal Pharmaceutical Society currently have no vacancies on the RPS QP Eligibility Panel of Assessors. In 2011, 2015 and 2017 we recruited new Assessors and would like to thank everyone who contacted us and took the time to apply for this role.

The RPS QP Eligibility Panel of Assessors comprises ten Members of the Royal Pharmaceutical Society who have experience in a quality role including acting as a Qualified Person. There is a balance of different areas of work and expertise on the Panel. 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 (3 Assessors).

The Assessor's position is voluntary and each Assessor contributes their time and expertise for an estimated 4-6 days per year. This includes attendance at an annual training day, along with the Assessors from both other organisations.

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, for example, via a Qualified Persons virtual network and via the RPS Professional Support Service.

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

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.

You can also contact the RPS Professional Support Service for further advice. The new Chair of the RPS QP Panel of Assessors can also be contacted via the RPS Professional Support Service.

Nigel Hodges, Immediate Past Chair of the RPS QP Panel of Assessors 
Catherine Duggan, Director of Professional Development and Support 

QP Briefing Paper describes the role of the Royal Pharmaceutical Society in relation to Qualified Persons.

Details
   

Additional Resources

Other careers can lead to interest in becoming a QP and our online groups (IPF and QP) include tips about finding out what interests you, getting a job and finding a mentor. Our professional development programmes will support any individual in any sector gain knowledge, skills and behaviours across all sectors and settings.

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