The MHRA Inspectorate are a busy bunch of people. With increasing numbers of new applications for WDA (H) licenses and a greater level of expectation on GDP standards, they have a lot of ground to cover – metaphorically and physically. So it should be little surprise that, with existing licence holders, they are looking for standards to be consistently improving.
The need to have a fully comprehensive Quality Management System (QMS) in place can-not be over-stated. SOP’s that clearly set out the specific steps for Good Distribution Practice (GDP) compliance. Accompanied with relevant Forms and Registers, which – with proper consideration – will point the way to continuing compliance. It seems simple, and with a methodical, experienced approach, it can be.
Unfortunately, however, there are frequent occurrences of inspectors being presented with nothing like they are expecting/wanting to see. Even when – in some cases – especially when, there had been a previously successful inspection.
In these instances, directions of business – and their associated risks – are often not accounted for. Differing transactions are not recorded fully and the perceived “always time to catch-up” ethos prevails. The assumption that, with the next inspection being so far away, it can be left until then. But the back-tracking is harder and less likely to be successful, because the inspections will be more specific and will drill-down in to your activities.
The resulting observations from the inspector, their pages of Major findings and expected actions, are usually more challenging – more time consuming and costly – than if the issues had been addressed (audit, Mock Inspection) far earlier. This can also result in the MHRA Inspectorate losing confidence with the incumbent RP, and with that the very real risk of a suspended or revoked licence.
The lesson a great number of WDA Licence holders are learning is that it will always be prudent to give their systems earlier attention – and seek advice and guidance – well before the Inspection is due.