The recent GDP/GMP symposiums both concentrated on  quality risk management, as compared to a previous emphasis on risk assessment.

MHRA inspectors appear increasingly unhappy that pharmaceutical companies appear to be throwing together risk assessments, without adequate consideration, and merely as a tick box exercise to satisfy the requirements of their QMS.

MHRA Inspectors want to see the rationale behind the risk assessment process i.e. how the ratings for low, medium and high risk are arrived at and how this risk is then continually monitored.  It is not sufficient to say that the risk is at an acceptable level and then leave it as is. MHRA inspectors want to see that risks are constantly being identified, reviewed and re-evaluated to ensure that procedures employed to reduce/remove the risk are still effective or could be improved upon.

Other topics that the MHRA symposiums focused on were:

  • Transportation: the emphasis being on failure to assess lost/stolen products within the QMS which in turn indicates ineffective Quality Risk Management. A major concern of the MHRA is that lost/stolen products are being under-reported.
  • Validation of data loggers used for transport route risk assessment. MHRA the inspectors want to see that the data loggers used for this purpose have calibration certificates and that they have been stress tested. Such requirements will have implications for the use of disposable loggers which are for single use and therefore become unusable once the stress testing has been conducted.
  • Cold chain – in particular freezer validation and the conditioning of cold packs. Terry Madigan’s MHRA inspector’s blog ( was cited as guidance.
  • Due Diligence – on diverted products. Warning signs to look for:
    • false document.
    • last minute changes to consignee details
    • requests to deliver to a residential address (this should be avoided if at all possible)
    • personal credit card or cash payments.

Be Aware! The diversion of products can be achieved by stealth.  Customers may obtain a subtle surplus of pharmaceutical product, over a period of time, and after gaining the trust of the supplier, which can then be diverted to the illegal supply chain.