Never has the corny old adage “Fail to prepare, prepare to fail” – so glibly used at times – been more wholly appropriate than for the build-up to an MHRA Inspection. It’s a demanding process requiring detailed attention, comprehensive descriptions, staff inclusion and teamwork. But it should be viewed as a positive exercise as well – one that can clarify your procedures, increase efficiencies and motivate all the staff.

As an organisation you’ve probably already gone through due processes and self-auditing. You will have decided what work you want to do (or continue to do) and what further opportunities there are. So you will be, at the very least, half way prepared. It’s worth bearing in mind that the Inspector will rarely, if ever, act like a hard-line referee. They actually want to help an organisation to achieve their targets and will usually give constructive and practical advice. But he/she will be meticulous, so you need to be too.

Don’t be afraid to self-analyse and ask a 3rd party (probably your RP) to run through your SOP’s like a new employee. As a Manager, either in Operations or Admin, you will be rightly proud and confident about your procedures as they are clearly working. But it can be vital not to be too defensive. Defending your ground on a procedure, when a legitimate gap has been identified – the “We’ve always done it that way” mind-set – is one of the major obstacles an inspector (and the RP come to mention it) will not feel comfortable with – or accept.

So, you’re putting things into place for an important day. The following points have been noted from recent inspections and could be worth considering for your build up: –

  • Ensure you Quality Management System is compiled as one complete set of files.
  • Look to define your procedures as MHRA specific, and not necessarily driven by ISO.
  • Documentation Control/ Version Control. They will be checked for consistency and clarity
  • Corrective Action Preventative Action (CAPA) – Show the process that is leading up to a corrective action
  • A CAPA register to be in place with expected completion dates. If these over-run then a brief explanation of why. Include the impact of the CAPA.
  • Detail the training that may be required as a result of an initiated CAPA
  • Consistency of control – formalising how changes are made and stick with it
  • Be mindful to not be too reliant on flow charts to demonstrate you processes and operational structure – greater definitions/descriptions of processes will be required. Who does what and how etc. The detail beyond the box.
  • Version Control. Establish what is good and correct practice. Stick with it.
  • Version numbers and page numbers to be consistent.
  • Change Control SOP should link to a Change Control Log which is all in the Change Control Folder
  • Be sure the SOP’s in place and are signed ( “Signed By” , “Authorised By”) and are not in “Draft” Version
  • Any Draft SOP’s are watermarked as “DRAFT” and are footnoted with “To be Authorised By”
  • Show vigilance on “Controlled Copy”
  • Deviations – Ensure the system is in place and, if necessary – and much like CAPA’s – link to training requirements.
  • Dummy Recall – Ensure you can demonstrate a complete Recall, displaying the full evidence of the process. Evidence of these being performed “Out of hours” may also be required
  • Your IT system updates are documented and evidence of prior notice being given, along with post implementation feedback from those who may have been affected by this action.
  • SOP’s on bone-fide check on Customers. Present consistency across the checks and information obtained
  • Demonstrate a check for any de-classified suppliers, on a quarterly basis, on MHRA website updates
  • Self-inspection. Show you have followed your schedule and the related SOP. Someone can’t self-inspect their own responsibilities, so if possible involve another Manager and your RP.
  • Training records to be relevant and comprehensive. Any training received to be self-assessed (questionnaire) signed and authorised – especially GDP training. Include any retraining given

The SOP on Management Review should mention precise frequency of Management Meetings. Annually is too infrequent