Assistance with MHRA Inspections and Pre-inspection audits

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We are often asked for assistance pre-inspection, and to help prepare a site in advance of the regulator’s visit.

How can we help you to help yourself?

If you don’t want to engage us to assist directly, then we recommend;

  • read our free and helpful blogs.
  • Check your compliance against the EU GDP Guidance update of November 2013, 2013/C 343/01 as this is the document against which you are marked.
  • Review the MHRA website – easier to find things by adding MHRA and whatever it is you seek to your Google search (other generic search engines are available)
  • get help from your peers – do you know others who run a good wholesale business? If so ask them for advice… but make sure they aren’t giving bad advice. How do you know? Ask to see their copy of their last inspection letter.

If you do think you need professional help we can visit in advance of your inspection date and assist with the following;

• Review your Standard Operating Procedures and Quality Management system, including anti-counterfeiting strategy/awareness

• Carry out a full audit, in the same fashion as an MHRA inspector

• Review your bona fides checks, temperature and cleaning records, and ensure that the RP has signed them off

• Track the lifetime of an order, from receipt of customers PO, through to sale and shipment

• Inspect the storage facilities and fabric of the building, including a pest control review

• Check your calibration certificates, temperature mapping of storage areas and fridges, and temperature records

• Check that deliveries are protected from bad weather and that goods-in is segregated from storage

• Review stock takes, recall notices, dummy recalls

• Investigate your CAPA and risk assessments

• Inspect the complaints protocols and file

This is not a complete list, but gives a flavour of what we can do for you.

What else can we do to help?

Do we offer coaching on how to “manage” an inspector like some companies? NO, we do not.

We have, however, added a fresh post on how to work with your inspector and get the most of your inspection.

Welcome to a new Paradigm!