CHOOSING A RESPONSIBLE PERSON
A guide for the WDA Licence Holder
August 2021
Madeleine Ault
Director and Senior Consultant
The Responsible Person is essential to every WDA holder; but what makes a good Responsible Person (RP) and how do you choose one? Is it someone who magically has 30 hours in the day? Is it someone with a good head for numbers? Is it someone who surrounds themselves with people who know everything?
Well, I think it is all of them and so much more. Most of us know how important this role is and how wide ranging the duties are, but the right attributes are difficult to define. It is up to the licence holder / the WDA holder to appoint the right person. How does the licence holder decide? What attributes must they look for?
Where do I find the requirements for an RP?
- The Responsible Person Gold Standard was approved in 2014. This was a collaboration between Cogent and MHRA. This sets out an industry framework that identifies the skills, knowledge and behaviours required by an RP. https://cogentskills.com/wp-content/uploads/2022/08/Responsible-Person-Medicinal-Products.pdf
- The Human Medicines Regulations 2012, regulation 45, sets out the requirements for a licence holder to nominate an RP who has the knowledge and experience to carry out the functions, activities, and procedures to be performed under the licence (my paraphrasing).
- GDP describes the responsibilities of the RP but little about the other attributes.
- In addition, the MHRA have published Guidance Note 6 which sets out the requirements and expectations. https://www.gov.uk/government/publications/medicines-notes-for-applicants-and-holders-of-a-wholesale-dealer-licence-or-broker-registration
By the way at time of publishing, (August 2021), Guidance Note 6 now seems to be overdue a revision, and that is exactly what might have happened when you come to read this article.
What if I get it wrong?
These requirements are extensive, and, in many cases, they are not very specific or quantitative. For a licence holder who must appoint the right person, it can be very daunting. Appoint the wrong person and you risk:
- Harm to the end user of the medicines
- Damage to the integrity of your business
- Compromising the integrity of the medicines supply chain
- Regulatory action against your licence
- In the most serious cases, possibly loss of the business altogether.
So, you can see “every easy choice will have its consequence tomorrow”. (Meryl Streep)
I need an RP now!
You are a licence holder, and you need a Responsible Person now. What do you do?
- You advertise but it’s a bit of a lucky dip – you get to choose from who applies for the role
- Head-hunting can be more focussed but be wary. If someone is prepared to leave their role then would they easily be tempted away from your role?
- Recommendations from other wholesalers or within your network.
- Or you go for a contract RP. Choosing a contract RP is a big risk for the Licence holder. You are outsourcing a critical activity to a third party. How do you choose?
- Or you choose from within your own workforce. ‘Growing your own’ also known as succession planning is an excellent long-term approach which I will cover later.
The MHRA have produced a long list of requirements, and it can be difficult for the Licence holder to know to what extent each requirements applies. Which of these can be evidenced at interview and which can be evidenced during an induction period or through further training?
I can’t produce the right person for you out of thin air, although SeerPharma UK can sometimes recommend the right RP for your specific operation, but I can help you with some recruitment and assessment guidance to work through systematically. You will see an example of a Licence Holder’s assessment of an RP in the tables to follow (as these tables are generic to some extent, there will be improvements you can make but it gives you a starting point). This divides the task into several areas to support the Licence Holder at:
- Application for the role of the RP – use these to design your application process
- Interview of the Prospective RP – these will lead you on your questioning
- On appointment with induction period – an induction period is always recommended before formal nomination as RP
- Review at end of the induction period.
It can be applied to external and internal recruitment. I suggest you apply all stages, being sure to assess after the induction period. Keep a confidential record of the assessment and don’t formally nominate the RP until you are content all these factors have been addressed.
Application for the RP Role
| Requirements | Essential/Desirable | Detail | Evidenced through |
|---|---|---|---|
| Location | E | Resident in the UK | CV |
| Availability | E | Continuously available, not over committed in all respects | Application form |
| Maths | E/D | C Grade or above at GCSE or equivalent | CV/Certificate |
| English | E/D | C Grade or above at GCSE or equivalent | CV/Certificate |
| ICT | E/D | Practical experience | CV/Certificate |
| Qualifications and knowledge | D | Some evidence of scientific qualifications. Job specific qualifications or training e.g., warehousing, quality, transport etc. | CV/Certificate |
| RP training | D | RP Training to the Cogent Gold Standard | CV/Certificate |
| Experience | E | One year relevant practical and managerial experience of medicinal products | CV/Portfolio |
| Experience | E | One year’s experience in maintaining a relevant quality management system. Contributing to the writing of an SOP or completing a change control record, for example, is unlikely, on its own, to be sufficient | CV/Portfolio |
| Experience | E | The applicant should have mapped their experience to company operations in respect of: • Scale of operations • Products handled • Range of customers and suppliers • Licensable activities – Procurement, holding, supply, export, import (under limited circumstances) • Operations e.g., cold chain, export Where a direct mapping cannot be made then the applicant should provide evidence to fill the gap | Application form |
| Continuous development | E | Evidence of a wide range of learning events – certificates, reflective accounts, evidence of application of learning | Portfolio |
Interview of the Prospective RP
| Requirements | Essential/Desirable | Detail | Evidenced through |
|---|---|---|---|
| Functional and Behavioural skills | E/D | Attention to detail, able to delegate, leadership, good judgement, following through on actions, communication | Questioning – suggest refer to the Gold Standard – ‘Functional and behavioural’ |
| Understanding of business model and wholesale operations in the role | E | Evidence of research into the company (and company group where relevant) extracting information pertinent to the medicine wholesaling operation. | Questioning |
| Skill set | D | Skills in continuous improvement, quality tools, qualification and validation, transport (e.g., risk assessment, root cause analysis) | Portfolio supported by questioning |
| Knowledge range | E | Knowledge of: • The MHRA and other regulatory bodies (e.g., GPhC, VMD, Home Office, EMA) • UK medicines regulations • GDP • Different types of medicinal product (able to identify these) • The Cogent Responsible Person Gold Standard • MHRA Guidance Note 6 (check this is still available on gov.uk) | Questioning |
| Pharmaceutical knowledge | E/D | Identification of medicinal product is essential. Where further pharmaceutical knowledge is not evidenced, the applicant should have thought of how they will access this | Portfolio supported by questioning |
| Technical knowledge | E/D | Some technical knowledge relevant to the expected operation is essential. Where further technical knowledge is not evidenced, the applicant should have thought of how they will access this | Portfolio supported by questioning |
| MHRA inspection experience | D | Able to discuss the experience and focus on the outcomes and actions taken | Questioning |
On appointment with induction period
| Requirements | Essential/Desirable | Detail | Evidenced through |
|---|---|---|---|
| QMS | E | Able to understand and apply existing Quality Management System | Evidence of training in practical terms and to relevant SOPs |
| Data / documents | E | Induction in the management of all forms of data and documents held and generated | Evidence of training in practical terms and to relevant SOPs |
| Personnel | E | Understand reporting line to Licence Holder and all inter-relations within organisational structure and own direct reports | Interview-based / mentoring |
| Responsibilities | E | Understand and ‘sign up’ to own responsibilities | Job Description |
| Outsourced activities | E | Overview of all outsourced agreements, control, and audit of these | Interview-based / mentoring |
Review at end of induction period
| Requirements | Essential/Desirable | Detail | Evidenced through |
|---|---|---|---|
| Own training records | E | Entries made directly relating to learning through induction period. SOP’s read, on its own, is not likely to be sufficient | Portfolio supported by questioning |
| Plans for review of staff training | D | The RP should now have developed some understanding of the company-wide level of knowledge (e.g., GDP, day-to-day operations) and may have developed some ideas of how to address any shortcomings. These plans should be realistic, risk-based, and evidence-based | Questioning |
| Plans for review of operational areas | D | Realistic plans in place for compliance improvements e.g., validation, temperature conditions, transport. Evidence that these are evidenced, communicated, documented and risk-based | Questioning |
| Records | E | Application of the principles of data integrity to all data and documents | Questioning |
| Management | E | Engagement with licence holder and/or senior management. Attendance at management review | Evidence |
| QMS | E | Evidence of active and risk-based engagement with QMS e.g. • Investigating deviations • Trending complaints, returns • Checking all documents reviewed • Review of change control • Evaluation of effectiveness of recall • Review of status of validations • Review of control and audit of outsourcing etc. • Review of supplier and customer qualification • Analysis of transactions, in particular unusual transactions | Evidence |
| Self-inspection | E | Consideration of how he/she would have oversight and add most value to self-inspection | Questioning and evidence |
| Continuously contactable | E | Has made arrangements to be continuously contactable | Evidence |
Contract RPs
Licence holders will often engage a contract RP. There are many benefits to this – the contract RP can bring a wealth of experience, expertise and provide that incredibly useful ‘fresh set of eyes’ for the business. But there are downsides. They can be over-committed, they can exaggerate their range of experience, they can lack a personal commitment to your company. In general, I feel your safer with an internal RP. I once became aware of a contract RP who left several Licence Holders in the lurch. He moved on pastures new and in one case, he left with company validation records on his own laptop, leaving the company with nothing to show the inspector. Most importantly, I have often seen a situation where the Licence Holder is so grateful to have engaged the services of a contract RP, that they fail to check them out properly. It is rare for a contract RP to be asked to show their portfolio and it is even rarer for the Licence Holder to audit this risky and essential outsourced activity. A good contract RP will be pleased you have assessed them thoroughly.
Succession planning
I consider that succession planning is the right approach to staffing. You cannot always ‘grow your own’ and sometimes you will want ‘fresh blood’, but succession planning is an excellent long-term approach. CIPD (cipd.co.uk) suggest first assessing which roles are business critical, the RP would certainly fall into this category. The next step is to identify individuals who can fit that role and the work experience, secondments, job moves and training they might need. Developing a pool of potential candidates provides more resilience and more choice in the future. As a consultant, I have sometimes been asked to support assessment of staff capability. This is a very fulfilling activity and draws on all those years as an inspector, seeing more junior staff stepping into this role with enthusiastic support and training from the Licence Holder.
A final message to the Licence Holder
There are some brilliant RPs out there. You can find the best and most suited to your operation. Effort up front will pay off in the long term. With a good RP leading your GDP operations and reporting back to you on a regular basis, you can focus on business development.
Sign up for our regular communications
It’s all here, from must-read articles, savings on training to being the first to know about new courses… of course you need to know!