What makes a good RP? – The Responsible Person (RP) title is the named person on a Wholesale Distribution Authorisation (WDA). As the saying goes, with great power comes great responsibility and all RPs should be aware of their responsibilities and make sure that they are fulfilling the requirements. However, RP’s need the support of the Licence Holder and it is important that the licence holder is also aware and fulfilling their obligations.
Within a Licence Holders operation, the RP is the central person ensuring good distribution practice (GDP) and compliance with the conditions of the Licence thus ensuring the quality of the medicinal products handled. In addition, the Licence Holder also has obligations and responsibilities to the RP that need to be fulfilled. One of the requirements is to provide the RP with adequate knowledge and experience for the role. This is a basic requirement and if not met the Licence Holder will not be compliant.
The legal basis and MHRA expectations are clearly set out. The Human Medicines Regulations 2012, regulation 45 states that the holder of a WDA ensures the availability of a ’Recognised Person’ and must notify the name of the person with the licencing authority.
The Licence Holder also has a responsibility to ensure that the RP is able and enabled to carry out their role effectively and within the EU GDP section 2.2, the RP is to be responsible for several aspects of GDP operations. The MHRA also sets out its expectations for the duties of an RP and Inspectors will continue to consider the suitability of an RP upon each inspection.
However, the RP is not required to be assessed by anyone other than the Licence Holder before taking on a role and there is no recognised qualification or central register to indicate the credentials of a person to be appointed as RP. If the Licence Holder gets it wrong with the appointment of a new RP, then the costs to the organisation could be huge and range from the adverse impact on the licence such as revocation or suspension to process inefficiencies and trading outside the legal supply chain.
The RP is named on a licence or licence application and will then be assessed by the GDP inspector at the next inspection. If the GDP inspector finds the RP is unsuitable then they will feed this back to the Licence Holder.
So, what makes a good RP?
There are several key areas in which an RP can demonstrate their suitability to a Licence Holder and the Inspector such as:
- Industry implicit and explicit experience, including relevant GDP experience.
- Primary and Induction training and role familiarity.
- Accurate recording of Training, RP, Licence Holder and staff.
- Training others and delegation, an RP is responsible for all GDP activities including those delegated.
- Ongoing development for the RP as the supply chain continually presents new challenges.
- GDP operations of the Licence Holder familiarity which can be particularly challenging in larger organisations.
- GDP knowledge and relevant regulations, textbook stuff.
- Accurate and defined role and place within an organisation including sufficient seniority and influence.
Conclusion
The suitability of an RP depends on knowledge and experience and the Licence Holder must be sure themselves as to the RP’s ability to carry out the licensed functions of the company as any non-compliance will place a significant burden on both the organisation and the RP.
The licence holder has a set of obligations and is required to provide an RP with adequate knowledge and experience. ‘On the job’ learning is quite usual in this industry, but experiential training can only provide for some elements and there is a real need for good quality external training which should be considered by all licence holders.
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