"Its was the best of times, it was the worst of times....."
Quality and compliance can often be taken for granted when everything is working well and there are no serious problems. It is, however, the result of significant effort- both to establish systems and a state of control and to maintain it. An army of often misunderstood and unsung heroes strive daily to make sure we supply safe, effective medicines to patients.
With all the best intentions, things do go wrong in our industry. Standards slip, issues arise, problems and challenges go unmet. Often, minor issues can grow into significant risk or weaknesses. What can appear noise one day can grow to a major problem the next.
Where companies identify their issues themselves, there is often an opportunity to mitigate or remediate these issues before they become life threatening. Often, however, it is our regulators who identify issues and this can lead to a dangerous, complex, costly and disruptive pathway of compliance management.
In the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA) operates two main levels of serious compliance management:
Compliance Management Team (CMT)
CMT is the inspectorate led process whereby MHRA manage a site back into compliance. This is often employed where no action is proposed to revoke, suspend or otherwise take action against a licence. This allows the GxP inspectorate to actively manage the site and review their remediation progress formally.
Inspection Action Group (IAG)
IAG is the MHRA multi-disciplinary process for taking formal action against a company, licence or individual. This is the forum at which licence suspensions, statements of non-compliance or forced variations take place. Cases from CMT may escalate to IAG and/or may be delegated back to CMT for ongoing surveillance.
Both options come with significant risk, cost and disruption and can lead to the loss of licences and the ability to manufacture & supply. For example:
Cost: A referral to CMT or IAG by an inspector is likely to result in significant remediation and multiple follow-up inspections. MHRA change for the review of responses and the administrative time- as well as the re inspection costs.
Time: Remediation efforts and CMT/IAG referrals divert significant resource and take time to manage effectively. IAG cases can take upwards of 12 months to resolve with significant resource allocation.
Reputation: Serious compliance cases can cause untold damage to business reputation. In many instances, companies are required by agreement to disclose CMT/IAG referrals and all such referrals are on record and potentially in the public domain.
Probably the most important risk is that of Patient Safety. Most regulators do not wield the tool of formal regulatory action unless there is a real, tangible risk to our patients and/or public health.
Usually as a result of a critical deficiency on inspection
IAG Letter & CAPA Plan
Opportunity to correct or respond to the issues
Licence Suspension or Action
Formal action against your licence
Reinstatement of licence and/or referral to CMT
Ultimately, it is the cause of the non-compliance which is most of interest after securing public/patient safety. What went wrong? Why? Could it happen again? Have the lessons been effectively learnt?
The most common causes of IAG referrals are as a result of poor quality mindset and culture and/or a significant shift in how quality viewed and respected within the company. Both of these causes can arise from a sudden shift in senior management priorities or new management itself.
Quality should have a voice in senior leadership and those with senior managerial positions should take the time to walk the shop floor and understand the quality mindset and the continual effort to maintain standards. Where issues are identified or escalated, these should be treated seriously and remediated thoroughly in-house.
Any serious regulatory non-compliance, IAG or CMT referral can be a daunting prospect. RamsayPharma have helped many companies with such situations and can offer rapid, pragmatic advice and bring a deep understanding of the process to help you mange the situation. Better yet- we can help you fix your issues before they get to that state.
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