Having worked alongside and helped to find jobs for Responsible People in the last year, I have noticed a real shift in the work being undertaken by RP’s. They are expected to fully understand the WDA (Wholesale Dealer’s Authorisation) license, meaning how to obtain this and keep hold of it through the MHRA. In addition to this having a good understanding of GDP guidelines, regulatory affairs, quality management systems and being responsible for supplier base integration are all key parts to the role. This is a lot of responsibility for one person and certainly over the year this has added more pressure to the role as companies look to an RP to be a leader within these fields. If I have noticed these changes from the outside looking in, then what must it be like for those professionals who actually work as an RP within the Pharmaceutical Logistics Industry. So I asked Nrandra Patel at Yourway Transport, Pelleren Hodges at Bollore Logistics and Mark Leach at Mawdsleys how their role has changed over the last 12 months.
Nrandra Patel (Yourway Transport):
"The RP has been generally responsible for the safeguarding product users against potential hazards arising from poor distribution practice. The role over the past 12 months has changed considerably Identifying risks, managing risks and balancing quality commercially. The RP today must ensure a robust Quality Management System has clearly been defined and controlled in a manner that permits tracking of all wholesale distribution activities taking place at the site, in addition understanding business environments improves understanding risks at all levels effecting quality. The role is evolving and changing rapidly in a global environment, continuous review and communication is crucial to ensure compliance with MHRA’s ever changing guidelines".
Pelleren Hodges (Bollore Logistics):
"Over the last 12 months I have maintained my core role as a Consultant RP and Quality Assurance Manager. Different aspects of my role have changed, not unsurprisingly in line with the specific industry that my clients work in; Pharmaceutical (aesthetics), Freight Forwarders, Supermarket Chain and Pharmacies, I also work within the veterinary sector, however, their equivalent to an RP is a WQP (Wholesale Qualified Person, not to be confused with a QP). The annual MHRA symposium tends to highlight what our regulatory inspectors are concerned with (focusing on?) and the latest trend in deficiencies that they have experienced.
The challenges of an RP for a supermarket chain, who only deal in ambient GSL products will vary greatly as for those of a Pharmacy, or Freight Forwarder who deal with a range of products at different temperatures, and then again there could be vast differences between the Pharmacy and the Freight Forwarder. Of course, the requirement to comply with the EU and UK rules and guidance is the same for all WDA holders, and as such the RP must ensure that the license holder operates within their license conditions, but the focus will either vary and possibly be much wider. For example, if the client is licensed for procurement only and outsources all their storage and distribution then more attention would be focused on that of the third party and the measures in place to manage the activities they undertake for the client. Furthermore, if they are a Freight Forwarder the challenges could be that of route profiling, and if required qualification. Segregation of freight, managing the extended supply chain and last mile delivery, not to mention the bona fide checking of clients outside the EEA. As you can see a Consultant RP gains an incredible width and breadth of experience across many industry sectors who wish to wholesale pharmaceutical products, and of course let’s not forget the suppliers to the wholesale dealers such as transport companies, it is the RP’s responsibility to approve any subcontracted activities which may impact on GDP, therefore ensure that they are compliant".
Mark Leach (Mawdsleys):
“Delivering service whilst being safe legal and complaint” How this as grown over the last 18 months has been incredible. Now within an RP’s armoury you must be able to draft and compose technical agreement’s and draft comprehensive risk assessments. The most fundamental change I have seen within the pharma wholesale sector has been transportation and storage conditions in the form of temperatures, adding to this various ranges of conditions for products such as “Do not refrigerate & 15°C- 25°C, experts we have had to become in quantifying service providers and diverse equipment suitable for guidelines. Adding to this due diligence which has also grown its scope in the form of restrictive measures on products. The days of just a clean and tidy warehouse will get you through are long gone!
Documentation has been driven to be more comprehensive rather than the historic SOP will tick the box approach. Work instructions and process flows are the new line in the sand all driven by a validated QMS system with a risk rated approach rather than an administrator with a spreadsheet. An interesting 18 months on reflection swopping the clip board for numerous software package’s on a laptop, who knows what the next 18 will bring".
These three instances highlight how the role of an RP has changed over the last 12 months in three different companies. The WDA plays a focal role within the Pharmaceutical Logistics Industry and the RP must ensure the license operates within the license conditions and in accordance with the regulations set out by the MHRA. As highlighted above by Nrandra, Pelleren and Mark, a move away from the tick box SOP paperwork to more computer based systems will make life easier for a Responsible Person. Given the changes that have happened over the last year or so, it will be interesting to see what changes 2018 bring to the life of an RP and the Pharmaceutical Logistics sector as a whole.