INSPECTION ACTION GROUP: 6 great questions answered

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

The Inspection Action Group (IAG) could be considered as the last port of call before persistent or serious deviations/non-compliances result in legal action.
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 critical deficiencies (or several majors that can be accumulated as one or more critical failures) in your operations and activities 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. In the event of a lower grade critical, it may be a referral to the Compliance Management Team (CMT).

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”.

2: “How can I avoid Inspection Action Group attention?”

The only way to avoid IAG action is to remain within GDP Compliance and to focus on 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, MHRA expectations and current GDP Guidelines, while 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 very 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. Do understand that the initial referral will give you typically 7-14 days to reply, depending on how critical the situation is.

Use the MHRA blog to help in your response – https://www.gov.uk/guidance/guidance-on-responding-to-a-gmpgdp-post-inspection-letter

If you really don’t have the answers, contact us for a confidential, free, no obligation review of your IAG letter and deficiencies. In extreme cases we may recommend a termination, especially if there is no benefit to patient health in supporting the case. In these instances we support the case at no charge.

The quality of your response will dictate whether there is an RFI (Request For Information), a proposal to suspend your licence, or remove the responsible person, which can be from 3-12 months, depending on the severity of the deficiencies and the expected time to remediate them. It is generally possible to shorten the time of suspension if appropriate works are carried out and a satisfactory re-inspection is held.

In extreme cases there have been immediate revocations (taking away) of the licence.

3: “So once I’m referred, I’m finished?”

No, the referral means the inspector will raise your case at IAG and you will receive a letter stating the deficiencies, and the response period, typically 7 or 14 days.

So what are my options?

a) Make a written representation to the MHRA

Your response should include what you are going to do to remedy the deficiency/deficiencies, when the work will happen, and how. Timelines should be risk-based and REALISTIC. Please note that elongated periods to remedy may result in a suspension, and any unrealistic promises will be challenged.

Each deficiency should be documented as a deviation, with an appropriate CAPA and if need be, change control. If your remediations include a new RP, training or other activities, please ensure that you know what you are doing and that you qualify any external providers ahead of engagement. If your RP is being removed, it is unlikely that you have the knowledge to recruit a new one, and we have seen this come up multiple times in these cases.

As keen as you are to correct the deficiencies immediately, do not make promises you cannot keep. It is possible to extend timelines, but it generally doesn’t look good if you miss target dates without good reason.

b) Request an oral hearing. You can arrange to appear before you by the licensing authority (either the MHRA or the VMD (Veterinary Medicines Directive)) and have them hear your case. However this comes at great cost; currently £10,000. 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.

Our advice is DO NOT DO IT. The individual that you will be speaking with is almost always the inspector who raised your deficiencies, and it is unlikely that you will have remediated the issues by then, so the reality is you are more likely to cause more damage with a face to face meeting, as you have no opportunity to take advice on answers to any questions from the inspector. When acting via letter, there is the added buffer of time, which can help you formulate solid responses.

Your successful representation may well delay or stop the proposed action, but your risk rating on the Sentinel system will have increased and you will be monitored 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.

4: “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 and deviations closed off, typically within 6 months, but could be sooner.
• The Inspection Action Group could request regular updates on the corrective action plan.
• Issuing a short-dated GMP / GDP certificate.

If serious and persistent issues of non-compliance continue in your company, then a referral will be actioned which will involve licence revocation and potentially a criminal prosecution.

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, or provide GDP services), it almost certainly will mean the end of your business.

5: “So what should I do to make sure the IAG are never involved?”

Stay in Compliance. Simples!

Also, ensuring the following are carried out can assist you in reducing perceived and actual risk:

• A rigourous self inspection programme, covering implementation of all of your GDP activities, subject to CAPA principles.
• External audits or supported self inspections from reputable companies (Paradigm has 7 Lead Auditors, for example)
• Regular staff training, relevant to their roles*
• 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 quality, 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 concerned and more thorough in their inspection process.

*Visit our blog on GDP Refresher Training for your staff.

 

6: “Where can I go to get what I need?”

Paradigm Shift Consulting Limited are a team of quality professional personnel who collectively have a comprehensive span of all matters concerning GDP, GMDP and medicinal cannabis compliance.
Our GDP webinars for RPs and Management are popular and occur every month, with discounts for team/group signings.
We are Cogent assured with (at the time of writing) 4 major courses including GDP Awareness Training, approved and accredited by the CPD.

We 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 and keep your patients safe, your staff content and knowledgable  in their roles and the MHRA satisified.

Use the form below to find out more or you can visit various pages on this website for more information.

Do take a moment to visit our GDP Training Website via the link button below to view the wide range of courses we offer.