Following a brief sanction, the MHRA are inspecting again and for the first time checking licences against the new guidelines. After being in attendance at a number of recent inspections, it is becoming clear that the focus of the inspections has been broadly related to the supply chain risk assessment, the quality management system and change control.
On this basis; are you ready for your next inspection?
In terms of the supply chain risk assessment, the inspectors have been requesting validation of the ambient supply chain including ex-works. This involves validating the temperature of the journey from supplier to wholesaler to customer and can be validated using certified data loggers. In some instances, there has been resistance from both suppliers and customers to logging journeys however this is now a condition on trading your licence.
The inspectors have also been very keen to look at the QMS or Quality Management System in place and how this will be managed and implemented across the subject business model. This should address maintenance of the SOPs, review of the processes as well as addressing complaints, returns and recalls. You will need to consider how these fit into the overall change control within the organisation and who is responsible.
Whilst on the surface, the requests are new for most licence holders and may appear tedious they are still designed with patient care in mind and do promote adherence to GDP.
If you have an inspection soon and need a pre-inspection audit or some general advice, call our office on 07544 264 863.