MHRA Pre and Post Inspection Support

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We can provide you with support before and after an MHRA inspection, whether this is with a pre-inspection audit and gap analysis or helping you to close deficiencies post-inspection, or in the worst case to come out of suspension/prevent revocation of your licence.

It will always be better for you if you contact us before an inspection (not one week before, ideally!) if you are worried, rather than being suspended for deficiencies that we could have helped you with.

Before an MHRA inspection we can audit your site, documents and operations, as well as reviewing your QMS and SOPs, to help you prepare and look to reduce the risk of major or critical deficiencies.

Working with your RP, we will give you advice on deviation management and suggest corrective actions to aim to be compliant with the EU GDP 2013/C 343/01 (which is what the MHRA will ‘mark’ you against).

This service is also included in some of our compliance support memberships.

We will provide your staff (whether warehouse, admin, RP or Senior Management) with competency based training that is relevant to their roles, and if there are gaps in their knowledge we can provide the training for you before the inspection – you must have evidence of the training.

If you need to create or update your training plan (EU GDP requirement) we can advise you on when and what training will be needed for each staff member/area of operation.

 

If you recently had an inspection which resulted in your licence being suspended, and you are willing to work to make the improvements needed, subject to an assessment of why you were suspended, your willingness to improve, and how much work is required to resolve the deficiencies.

We can support you in creating effective procedures and taking action to be compliant in the areas where deficiencies were found.

We can also support you with what to do if you have been referred to the CMT (Compliance Management Team) or the IAG (Inspection Action Group) after an inspection.

If you passed the inspection but there were some minor (classed as ‘other’), or major, deficiencies found we can help you implement actions to correct them and prevent their reoccurrence.

If these are not suitably remediated they will be upgraded to the next level of deficiency at your reinspection, which could result in further negative action.

It is always better off fixing an issue as soon as it is identified, and ensuring your review any resolutions to ensure that they are effective.

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