Phew…..that was exhausting!!! I know that is a usual comment after an inspection but this was a two day (and two inspectors, a lead inspector plus a trainee) under the new Licence Based Inspection process. It was not a surprise that the inspection was thorough, covering most, if not all aspects of the legislation and GDP but it was well organised and well led by the lead inspector. I like to think that we had prepared reasonably well in terms of the QMS and core systems, but it is fair to say that we should have made sure that there was better access to records held at the other sites. A lot of our records were paper based and getting these back from the other sites in what felt like a timely way was stressful. Other observations?
- I think the standard MHRA pre-inspection letter probably needs to be amended for this sort of inspection.
- Obviously, a key area that is looked at is how the centre and other sites interact and how the Licence Holder and RP ensure uniformity of application of the QMS and ensure appropriate compliance. This should be clearly mapped out and risk assessed, and if appropriate the mechanisms should be clearly set out in the QMS. In most situations you will want a unified QMS but having a separate site master file for each site named on the licence would be a good way of driving oversight but also keeping things well organised.
- Make sure you have a clear strategy within the self-inspection process that covers both overall compliance but also site compliance as well.
- Again stating the obvious, but carefully check the licence and that all site details are correct.
I think this type of inspection is a welcome move but as my colleague warned on a previous post, part of this process is the possibility of un-announced visits to other sites. Again, this eventuality is something that should be thought through, risk assessed and documented within the QMS to make sure they go smoothly if and when they happen.
