An Inspector Calls

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The Inspectorate of the Medicines and Healthcare Products Regulatory Agency may call upon you as part of your usual, and announced, inspection schedule, or upon the receipt of information.

Most inspections are announced, but there is talk of unannounced inspections coming into play. These would separate the men (and women) from the boys (and girls).

Manufacturing sites are already “at risk” with short notice or unannounced inspections.

Paradigm Shift Consulting recommends that you are always inspection ready, and should be acting as though you are expecting an inspection that day or the next.

Aim for excellence.

Depending on the outcome of your regular, or unannounced, inspection your risk profile can change. You want your perceived risk as low as possible and to evidence that you are compliant with GDP and both understand and care about your business and responsibilities.

During an inspection this week one of our customers were inspected by a Senior GDP Inspector, who was extremely thorough and spent the majority of the day cross referencing documents, asking pertinent questions and tracking products.

The customers responsibility was to evidence compliance, and when the comments on the follow up letter are dealt with, they will be issued with their compliance certificate which will show on the Eudra GMDP website.

During the closing meeting the customer was commended for our speed and efficiency in responses and batch tracking abilities, and that we were open and at no point tried to avoid questions or change the subject.

The Inspectorate are like elephants… (no disrespect intended)… they do NOT forget. If asked for a piece of paper/electronic file, you should know where to find it and be able to access it quickly… Not shuffle things, mumble a bit, wander off and hope they’ll not notice you are stalling/unable to comply.

How can you assist your MHRA Inspector during their visit?

  • If your business allows it you should have a knowledgeable “runner” to hand – your shop floor staff should be your experts, and should know what is where.
  • Keep all documents to hand, and in good order – Electronic documents, with backup, have been a suitable alternative for some time. Preferably PDF or scan of the original paper, or entered into a system that doesn’t allow future manipulation.
  • Have appropriate folders for hard copy or soft copy – The filing system should allow you to access your documents quickly and confidently. The more expeditious you are with getting your hands on what the inspector wants, the more likely you are to make a good impression!
  • Take copious amounts of pertinent notes – Many of the comments made won’t appear on your PIL (Post Inspection Letter) but are worth recording and acting upon nonetheless. You pay a significant sum for the inspection, so we recommend to take the most value you can from it.

What documents should you have ready, whether electronic or paper?

  • Quality Management System and Standard Operating Procedures
  • Risk Assessments
  • CAPAs
  • Change Controls
  • Cleaning Records
  • Temperature Records and annual calibration certificates
  • Records of deviations and any remedial actions taken
  • Records of equipment servicing
  • Records of system validation
  • Records of packaging validation
  • Contracts with third parties – Pest Control, Logistics, Fridge/aircon servicing etc
  • Stock records, returns notes, transfer records and quarantine
  • Remember all paper or electronic records should be maintained for at least five years, and in the case of the e-copies, a suitable (and regular) back up made

Our team have been present for enough inspection to know that even when you think you’ve got it nailed there is something that is commented upon, but if you invest enough into training, increasing your standards and aiming for excellence and quality  a few comments may be your reward.

To better understand the classes of deficiency, view this post; Class of Deficiency in Good Distribution Practice

Check our other blog posts, including how to “handle” the MHRA.

We do not recommend that you pay someone to coach you in your inspection.

If you are genuinely concerned commission us for a mock MHRA inspection / third party audit and close the obvious gaps you may have, you will get more value from that than being told how to behave… which should come naturally to anyone with common sense… But as they say, “Common sense isn’t common.”

Our audits involve 2 or 3 of our team coming to your business to dig and delve into history, records, procedures, liaise with staff, management and the Responsible Person and provide a comprehensive report.

For those requiring more urgent support we do a “Same Day Audit Service” which includes a full GDP audit, a list of deficiencies and the audit report the same day, instead of the typical “up to 30 day” wait.

Our audits include support with closing the deficiencies, although new procedures, training or RP support is not included in the price.

Contact us at Paradigm Shift Consulting, “Where Common sense is common,” for a no obligation chat.

We prefer emails to start, and see if we can take a pragmatic and cost effective way to help you achieve your goals.

Welcome to a new Paradigm!

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