In the past, the MHRA has told a pharmaceutical wholesaler to find a new Responsible Person when they did not know the correct definition for “GDP” in their MHRA inspection. The RP used the “ Gross Domestic Product “ definition to his peril.
But little did the MHRA know that the drastic effects of the Covid-19 pandemic on the country’s Gross Domestic Product “GDP” was to affect some UK Wholesalers and the UK medicinal supply chain in such a deleterious way.
Some sites are closed temporarily, others are much busier, some are working shifts to protect their workforce. Visits to sites by auditors and even RPs have been banned. Audits and training sessions are being carried out over Teams, Zoom and Skype.
RPs are struggling to assess the affect Brexit and potential 2nd waves of Covid-19 will have on their licence holders and their staff compliance to the QMS and GDP and their profitability.
Financial pundits are struggling to predict if the recovery will follow a “ V” shape and bounce back or “ U” shape when the recovery is a little slower to respond or a “ W” shape if we have a second wave and the economy will suffer again if we end up back in lockdown.
The UKs economy recovery and both “GDPs” must be considered by the RPs and WDA holders to ensure that their business survives and that all risks are considered so that they weather the potential storm.
Contract RPs and employed RPs must try to ensure that “Quality” is not forgotten, that GDP audits are carried out, that importers of medicines from the EU have an RPi in place as soon as possible and that the new procedures required are drafted and that licence holders are prepared for whatever shape we are in in 2021.