MHRA inspections: what to expect and how to prepare

What does an inspection involve? 

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for protecting public health by overseeing the safety and quality of medicinal products in the UK. In support of this, the Inspectorate at the MHRA (the Inspectorate) licenses and inspects all UK manufacturers, wholesale dealers and importers of medicines, and inspects clinical trials and toxicology laboratories, and will review to determine whether sites are complying with Good Practice (GxP).

The Inspectorate has extensive powers, including inspection, sampling and seizing, which apply to areas such as manufacturing, importation, quality control and testing, transportation, and storage of medicinal products. Inspections normally involve interviewing relevant personnel and reviewing systems, equipment and documentation - with the nature of the site determining the areas of particular interest. 

When do inspections take place?

Sites will undergo an inspection when applying for licences. Routine inspections are also carried out at intervals. The Inspectorate operates a risk-based inspection programme. Routine inspections are scheduled based on the risks identified for a particular period, with priority given to new, high-risk or previously non-compliant sites. The Inspectorate also has the right to carry out unannounced inspections. These inspections are often triggered by intelligence about a potential breach from whistleblowers or other regulators or MHRA teams. 

How can your business prepare?

Bear in mind that inspections can occur at any time. Make sure that your site remains inspection-ready by routinely carrying out audits of your quality system and processes, and ensuring that employees are up to date with their training. When your business becomes aware that an inspection will take place, there are some key actions your business should take:

• Consider engaging a regulatory consultant to support with inspection readiness.  We can introduce you to one of our connections, if desired. 
• Review records of previous inspections to confirm that all actions have been completed and closed out on time.
• Perform an internal audit or mock inspection (perhaps with the support of an external specialist) to identify any issues or areas of improvement.
• Ensure that key personnel are present, prepared and available during the inspection. This will facilitate smooth communication and provide inspectors with prompt access to relevant information. 
• Set up a well-organised back room for handling documents and providing timely responses to the inspectors.
• Keep senior management informed throughout the inspection process, so they are well-prepared for closing discussions. Senior management should also attend the opening and closing meetings to demonstrate top level commitment and ensure oversight.

What can your business expect post-inspection?

During the closing meeting, the inspector will usually confirm if they plan to make a direct referral to the Compliance Management Team (CMT) or Inspection Action Group (IAG).

• CMT handles cases of poor compliance and a referral will be made if there are significant concerns, but there is no immediate evidence of a critical deficiency or a need for regulatory action. CMT monitors progress, engages with senior management and may recommend closer monitoring or further inspections. If sufficient improvements are not made within the required timeframe, the case may be escalated to the IAG. 
• The IAG deals with critical deficiencies following inspections, but referrals can also be made for other reasons such as if a site refuses to allow an inspection or if concerns are raised by other regulators. There are a range of actions that may be taken following a referral to the IAG - possible actions include refusing, varying or suspending licences, increasing inspection frequency and referring to the MHRA Criminal Enforcement Unit.

The inspector will issue a post-inspection letter outlining any deficiencies identified during the inspection. A response must be sent within the timeline specified by the inspector, outlining the proposed corrective actions and implementation dates. It is important that your response is full, detailed and outlines a clear plan for dealing with deficiencies. If the inspector decides that the response is inadequate, the matter may be referred for compliance escalation.

What steps should your business take post-inspection?

Inspections can have a range of outcomes. Irrespective of the findings, it is important that your business fully reviews the regulatory, internal and reputational implications and promptly takes appropriate steps to deal with any issues. Here are some practical tips:  

• Key personnel and senior management should liaise to provide practical corrective action plans tailored to address inspection findings. We can support with this process and assist you in preparing clear and robust responses to post-inspection letters.
• Review your agreements with other parties in the supply chain. You may be obliged to notify your suppliers, distributors or other parties if:
  •  You are inspected;
  • Any deficiencies are identified; and/or
  • Your site is referred to CMT or the IAG.

We can support with reviewing your agreements and identifying any actions you are contractually required to take pre- or post-inspection.

• If necessary, draft a strategy for dealing with any reputation management issues. Carefully review and pause before releasing any internal and external communications, and consider seeking external legal advice to ensure that your communications align with regulatory and reputational considerations. Our team has extensive expertise in reputation management and can offer advice on communications and helping mitigate reputation risks in the event of a poor inspection outcome, whistleblowing or compliance escalation.

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If you'd like support with any legal issues relating to MHRA inspections or contractual matters, please contact Emily Dyer or Andrew Andrews who would be happy to assist you in navigating these complex regulatory processes.

*With thanks to Emma Baber for her contributions to this article.