“I don’t know much about the Inspection Action Group. Who are they?”

The Inspection Action Group (IAG) could be considered to be the “sharper end” of the MHRA. The IAG has two “wings”:

IAG1 concerns itself with Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and Blood Establishment Authorisations (BEAs).

IAG2 is concerned with Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GPvP).

If an MHRA Inspector finds serious discrepancies in your operative functions in data, documentation, storage/handling that are a critical failure (or several majors that can be accumulated as one or more critical failures), then the inspector will automatically refer you to the Inspection Action Group. This is especially the case if the deviations and discrepancies or failures seem to be repeat occurrences.

There are comprehensive lists of reasons given for the IAG’s intervention as a result of a referral given in the MHRA’s document, “Actions as a Result of Referral to the Inspection Action Group”.

“Can I avoid the IAG’s attention?”

The only way to “avoid” IAG action is to work towards compliance and continual improvement throughout your quality system. In other words, run a tight ship and keep your nose clean!

• By remaining compliant with the Human Medicines Regulations 2012 and GDP Guidelines, maintaining and improving your Quality Management System at all levels, you greatly reduce your chances of an IAG referral.

A referral to the Inspection Action Group is incredibly serious and should be treated as such! It is essential that you acknowledge receipt of any letters as a matter of urgency and adhere to any provided deadlines, while recognising that the initial referral will give you typically 7-14 days to reply, depending on the criticality of the situation.

Your response will dictate whether there will be a proposal to suspend your licence, which can be from 3-12 months (depending on the severity of the deficiencies) and the expected time it will take to remediate them. It is generally possible to shorten the time of suspension if appropriate works are carried out.

“If I get referred, does that mean I’m finished?”

No, it’s not too late to respond. It is always best in the first instance to treat a referral as a requirement to correct the deficiencies immediately, as promising to deal with it later is not going to stop the Inspection Action Group’s progress.

But you could…

• Make a written representation to the MHRA
• Appoint a person to appear before you by the licensing authority (either the MHRA or the VMD (Veterinary Medicines directive)) and hear your case. However this comes at great cost; currently £10,000.

A prompt written representation to the MHRA (or VMD in the case of veterinarian practices) will be helpful.
The MHRA are duty-bound to take your representation into account and it must be considered. No proposed action can be progressed until this has happened. Your representation (if it is a good one) means that the Inspection Action Group will have to make a recommendation as to whether to proceed with the proposed action or not.

Your successful representation may well put off the proposed action, but the fact that it happened at all means that you will be watched very closely for some time. It does not in any way excuse you from making the necessary changes to rectify the issues raised; this still has to be done immediately and maintained, if you want to decrease the likelihood of attracting the Inspection Action Group’s attention in the future.

If you choose to have someone appointed to hear your case in person (expensive though that is), they are only able to offer their opinion to the licensing authority (the MHRA). The process of review and re-evaluation as to further action will still take place in the same way.

“So I won’t see the IAG after this? The heat will be off?”

Not quite…

Even if your written representation (or in-person representative) is successful in causing the IAG to take no further action, there are follow-up actions that you will be subject to, such as:

• A re-inspection to ensure that the corrective actions have been implemented
• The IAG could request regular updates on the corrective action plan
• Issuing a short-dated GMP certificate

In addition to these, the IAG may also:

• Recommend an increase in the frequency of inspections
• Monitor your company via inspectorate updates which must be provided to them by the inspectorate when requested

If serious and persistent issues of non-compliance continue in your company, then a referral will be actioned which may involve criminal prosecution. This is highly likely if the issues have been repeatedly unresolved over months or years.

To allow non-compliance to go unchecked in your company could bring you to this point and when the potential cost of inspection and re-inspections are added to the lost revenue of halted transactions (remember if you are suspended, you are unable to buy or sell), it almost certainly will mean the end of your business.

“So what should I do to avoid referral to the Inspection Action Group?”

There are a variety of things that must be undertaken at regular intervals if you are to avoid serious problems with inspections, audits and ultimately involvement of the IAG and potential criminal prosecution.

• Regular staff training.
• Responsible Persons, Licence Holders and Quality Personnel fully updated
  with the latest regulatory requirements via training.
• Have a maintained and strong QMS (Quality Management System) in place.
• Encourage a culture of thoroughness, care and due diligence throughout the company.
• Pay attention to detail! If your premises look neglected, it will reflect badly upon your company and potentially will cause inspectors to become more concerned and thorough in their inspection process.

“Where can I go to get help?”

Paradigm Shift Consulting Limited are a team of quality professional personnel who collectively have a comprehensive span of all matters concerning compliance. Our GDP webinars for RPs and Management are popular and occur every month, with discounts for team/group signings.
We are Cogent assured and are not interested in just simply taking your money. We are all here to resolve the same problems with the same goal in mind: The Safety of the Patient.

Help us to help you do a good job! Call us to find out more or send us a message from the form below. Alternatively using the link buttons shown visit our parent website for further information and helpful articles or our courses page on this site.