Closing Meetings: What to expect from the MHRA Inspector 

A closing meeting overview following an MHRA GDP Inspection 

A closing meeting following a third party, MHRA (Medicines and Healthcare products Regulatory Agency) audit, most commonly referred to as an inspection, is a critical part of the inspection process. It serves as a formal opportunity for the inspector or inspectors to present their findings to the company. 

In this blog we will provide some basic details of what typically happens during closing meetings and what happens next: 

Purpose of the Closing Meeting 

1. To communicate the inspection findings to the Responsible Person (RP) and senior management. 
2. To outline any deficiencies noted during the inspection, and clarify any potential misunderstandings. 
3. To explain any potential regulatory actions, such as referrals to internal MHRA committees (CMT or IAG). 

Presentation of any Findings 

The inspector will summarise the inspection scope, the areas audited on the day(s) and detailing the guidelines the inspection was performed agains.  More information regarding GDP regulations can be found HERE.   

Where nonconformances against GDP guidelines have been discovered, the inspector will link the deficiency to the relevant guideline and describe what it is that they have found. For example, if the QMS Standard Operating Procedures have not been signed and dated by the Responsible Person, this will be described by the inspector as a non-conformance against GDP Guidelines Chapter 4, Part 4.2. 

The inspector will categorise the deficiency in one of 3 ways: 

1. Critical – • A “Critical” causes, or leads to a significant risk of causing, a product to be harmful to a human or veterinary patient

   • Or a product which could result in a harmful residue in a food producing animal.

   • Alternatively a critical deficiency can be the combination of a number of major deficiencies that indicates a serious system failure.

2. Major – • “Majors” are non-critical deficiencies which have caused or may cause a product not to comply with its marketing authorisation;

   • or which indicates a major deviation from EU Good Distribution Practice;

   • or which indicates a major deviation from the terms and provisions of the Wholesale Dealers Authorisation (within the EU);

   • or which indicates a failure to carry out satisfactory procedures for distribution of medicines or (within EU) a failure of the Responsible Person to fulfil his legal duties;

   • or a combination of several “other” deficiencies, none of which on their own may be major, but which may together represent a major deficiency and should be explained and reported as such.

3. Other (Minor in GMP) – • A deficiency which cannot be classified as either critical or major, but which indicates a departure from good distribution practice.

   • “Others” can also be comments.

   • (A deficiency may be “other” either because it is judged as minor, or because there is insufficient information to classify it as major or critical).

   Inspection findings can come as a surprise or shock, especially if critical or multiple major non-conformances have been found, and if the company doesn’t fully understand the requirements for someone holding a WDA.

Do not try to argue with the inspector, or defend the deficiency found, UNLESS there is a misunderstanding on the inspector’s part OR you are confident and competent in GDP, and can clarify the issue!

Listen carefully to their findings and acknowledge any failings they may have found. You will have your chance to respond to their findings in their post inspection report response. It is highly unlikely that you will be able to contradict the findings after the inspector has left site, and will be asked why you didn’t raise it in the closing meeting. 

Inspection Reports 

Within a few days or weeks of the inspection, the MHRA inspector will issue the official inspection report. This is usually sent directly to the Licence Holder. This report formalises all of the findings discussed during the closing meeting.
It is highly likely that a response to the report will be required, especially in the case of critical or major findings.   

Possible MHRA Referrals 

If the inspector has documented critical or multiple major non-conformances on the inspection report, you may find that your organisation has been referred to one of two areas of the MHRA:  

Compliance Management Team (CMT) 

CMT referral usually occurs when multiple major nonconformances have been found and there is a potential risk to patient safety and the wholesaler has not been able to demonstrate adequate compliance with GDP guidelines. The CMT is made up of Senior Inspectors who will review your progress.

1. CMT referral may result in regulatory actions such as: 
2. Suspension of the Wholesale Dealer’s Licence.
   
3. Escalation to IAG if suitable responses are not provided. 
4. Referral for legal action if required.

Inspection Action Group (IAG) 

IAG referral usually occurs when critical and high numbers of major nonconformances have been found and there is a severe risk to patient safety and clear evidence of serious noncompliances against GDP guidelines systematically throughout the organisation. You will be informed at the close out meeting that you are heading to IAG.

IAG referral can be the catalyst to significant enforcement actions, including: 

1. Suspension or revocation of the WDA. 
2. Referral to licensing teams for the removal of certain categories, dependent on the inspection findings.
3. Referral to the Enforcement Team, or Police, in the event of criminal activity or loss of controlled drugs.

 Further information on what happens when you have been referred to CMT or IAG can be found here. 

The inspectors report will dictate the response time for the company’s response; these response times range from 7 days to 14 days. 

Company Responses to Inspection Reports 

Once you have received your inspection report, take your time to digest and understand the inspectors’ comments. You will need to respond to the report in the time specified in the report. Don’t panic and don’t rush your response!  It is highly recommended that you seek advice from specialists in inspection remediation such as Paradigm Shift Consulting, should your inspection report include referral to CMT or IAG. Paradigm Shift (as far as we know) are the ONLY GDP consultancy offering a free review and input on your CMT or IAG letter, and are the UK’s leading GDP consultancy for remediation services.

Your response should include acknowledgement of the nonconformance and details of how you intend to rectify the deficiencies. 

The written response should include: 

1. A root cause analysis of each deficiency. 
2. Corrective and Preventive Actions (CAPAs). 
3. Implementation timelines, ensuring that they are realistic. Suggesting work will all be completed within a week, when the deficiencies are deep and complex could result in suspension of your licence. Also suggesting it may take months may result in a full or partial suspension.
4. Top tip: Do not supply evidence of your CAPA or remedial work, unless requested by the inspector. 

Your response will then be reviewed by the inspector and, if necessary, discussed internally or escalated. 

The outcome could be: 

1. Continued compliance and normal inspection frequency. 
2. Shortened inspection frequency, especially in the case of CMT or IAG referral. 
3. Increased oversight or conditions placed on the license. 
4. If your response does not satisfy the requirements of the inspector and the GDP guidelines, you may have your license suspended or revoked. 

Once the inspector has reviewed your response, they may request further information or evidence or confirm the inspection has been closed and provide you with your estimated re-inspection timeline. 

It is important to remember that the inspection was based on a sample of your operations and to ensure full compliance in all areas you review all of your processes to check for compliance.
Just because the inspector didn’t document issues elsewhere in your organisation, it doesn’t mean they are fully compliant! We are frequently asked to resolve issues within a letter, however a full, deep-dive audit should be the starting place. Inspectors may only list the critical issues, but from the audit have uncovered other issues. Merely responding to the deficiencies in your letter could result in ongoing MHRA visits every 6 months, or suspension for failing to identify other issues. Remember that we must retain records for 5 years, and even with a clear inspection before you could end up visiting IAG!

If you would like a full QMS audit of your system to check your current compliance status, require support post inspection or if you require remediation assistance following CMT or IAG referral, please get in touch and we will advise you on the most appropriate steps and actions you need to take. We can even place Responsible Persons, Responsible Persons (import) and Quality Assurance Specialists in your organisation. 

Further Reading:

Check out our other post-inspection related blogs listed below.

Inspections and Audits

External (Second Party) Audits: Their Importance

MHRA Inspections: Are You Ready?

MHRA are our Friends

Should I Seek Legal Advice?

Suspended and Revoked Licenses