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;

– Reading our free and helpful blogs.

– Checking 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”.

– Reviewing 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).

– Getting 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;

• Reviewing your Standard Operating Procedures and Quality Management System, including anti-counterfeiting strategy/awareness.

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

• Reviewing your bona fides checks, temperature and cleaning records, and ensuring that the RP has signed them off.

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

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

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

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

• Reviewing stock takes, recall notices, dummy recalls.

• Investigating your CAPA and risk assessments.

• Inspecting 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.

We also run monthly training sessions on GDP – to find out more check out our training page. Another service we offer is compliance support memberships which can help you to ensure you are ready for inspections and GDP complaint.

Welcome to a new Paradigm!

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