MHRA inspections -most common deficiencies
80% of all deficiencies found by MHRA inspectors during inspections of wholesale dealers of medicines premises concerned just 3 subject categories :
* Temperature Conditions
* Quality Management Systems (QMS)
With temperature conditions, the most common inspection failures were concerned with the control and monitoring of ambient storage conditions, the control and monitoring of cool chain storage and finally cold chain transportation. With global warming, it is not at all uncommon for the UK to experience ambient temperatures in excess of 25C and within buildings and transport containers such temperatures can easily be exceeded for sustained periods. Only very well insulated warehouse buildings are likely to be able to live within 25C without a cooling system
With QMS, the main failure areas were: Unauthorised activity, Quality system and the RP duties, and self-Inspection audits. As the current consultation on changing GDP guidelines has much to say about QMS including making a QMS obligatory for all WDL holders, this area is one that RPs and managers need to focus on in 2012, before the new guidelines come in in 2013.
With documentation, Lack of or inadequate procedures, or the availability of adequate documentation were the main failures. From 2013, documentation will become subject to version control and records will have to include batch numbers where required
As the MHRA now run a “risk-based system” to calculate wholesale dealers premises inspection frequency, good results at an inspection now, could result in future less frequent inspections, saving wholesalers money in the long run.