For the last 3 years, when delivering GDP Training, and when it comes to the subject of Transportation – and the related GDP requirements – there has always been stock comments and specific observations. These will be centred around the (understandably) perceived inconsistencies on how the Transport guidelines are applied to the vast majority of Wholesalers, compared to the very few (Top 3) Wholesalers within the UK. Many trainees, whether having had some experience of receiving deliveries from “The Big Boys” within a Pharmacy or Wholesaler capacity, voice their incredulity at the increased standards of transporting Pharmaceuticals (Packaging validation, Dedicated vehicles, appropriate segregation, Route Qualification, tracking information, in-transit temperature data etc) and how these could and should be applied to their own activities. Examples are always given of poor deliveries received, horror stories are exchanged. The frustration is evident, and the group conversation turns to, not only what the potential damage to products may be, but how this looks. How this, what looks like a flouting of regulations by the main players, could erode the integrity of the Guidelines and the work all responsible wholesalers have undertaken in this area.
It was interesting to learn, then, that at least one of the main Wholesale suppliers in the UK received a critical GDP Inspection finding for Transportation. The Inspectorate are not after all, as some had suggested, powerless to enforce these expected requirements. This news, once shared, is having an impact on many people’s thinking – on 2 fronts. Firstly, that the effect of follow-up actions can only lead to better treatment of products, improving the chances that their integrity and efficacy will not be compromised. That products won’t be so frequently damaged (a common complaint) and information on products details, and perhaps Temperature data within transit, might be more forthcoming. Excellent.
There is also the realisation that if the MHRA Inspectorate are finding enough deficiencies within the operations of what are very professional, large and successful organisations, they are going to apply at least the same diligence when inspecting everyone else. That thorough approach to your Transport processes, doesn’t seem so “over-the-top” now. Put bluntly, if they are going after the big boys, they’ll go after everyone else.The Transport requirements within GDP are there for very good reasons. Safety of product and safety to patients. It can seem a hard slog to ensure you meet these requirements – and provide the necessary evidence. But it’s re-assuring to know that the compliance should become even more widespread