When It All Goes Wrong

by Dave Rushton

Our 2025 Annual Conference concluded with a powerful and uncompromising session from the UK GDP Association's Chair, Dave Rushton, focusing on what organisations must understand and prepare for when things go seriously wrong in GDP compliance.

About Dave Rushton

Dave Rushton is the founder of Paradigm Group Holdings, a group of companies focused on supporting the pharmaceutical manufacture and distribution sectors, including Paradigm Shift Consulting, a UK-based consultancy specialising in GDP remediations, contract Responsible Persons and Quality Assurance personnel, regulatory support, training and quality management for the pharmaceutical industry.

Dave opened by outlining the worst possible outcomes following significant regulatory failings:

Licence Outcomes: Revocation, Suspension and Termination

·         Revocation - The Medicines and Healthcare products Regulatory Agency (MHRA) removes the licence entirely. The business is no longer permitted to trade medicinal products. 

·         Suspension - The MHRA temporarily halts trading for a defined period, giving the organisation time to address serious deficiencies and return to GDP compliance.

·         Termination - The organisation voluntarily hands back its licence, sometimes prompted by and inspection, sometimes due to strategic changes.

The MHRA maintains a public register of suspended, revoked and terminated licences, updated frequently. Dave stressed the importance for quality teams to subscribe to the MHRA alerts and routinely review the register, ideally every two weeks.

Understanding CMT and IAG Referrals

Dave provided clarity on how the MHRA inspectors escalate concerns:

·         CMT (Compliance Management Teams) and IAG (Inspection Action Group) referrals occur when major or critical deficiencies are identified.

·         These referrals substantially increase the workload for inspections, up to 10-20% more and offer no financial incentive to the inspectorate.

·         The sole driver is patient safety and maintaining supply chain integrity

He reminded attendees that an inspection is only a sample of operations. A clean inspection does not guarantee an organisation is fully compliant, it simply means no critical or major issues were identified within the sample reviewed.

How Deficiencies are Categorised

MHRA inspectors access compliance against GDP guidelines, categorising deficiencies as:

Critical:

Presents a direct, significant risk to patient or animal safety, or involves a cluster of major deficiencies in a single area of GDP.

Major:

Significant but not critical to patient safety, could include:

·         Performing unlicensed activities

·         Deviations from GDP guidelines

·         Or several related issues within the same process area

Others:

Minor departures from GDP, examples include:

·         Missing page numbers

·         Use of non-indelible ink

·         General concerns or comments

All deficiencies are documented in the inspection report with the relevant GDP guideline clause references.

 

Inspection Letter Types and Response Timeframes

Following your inspection closing meeting, depending on the findings, the organisation inspected receives different MHRA inspection letter types:

Type 1

A small number of major deficiencies with a 28-day response timeframe.

Type 2

Multiple major deficiencies with a 28-day response timeframe.  Future inspection frequency also increases, for example, every 2 years instead of every 4-5 years.

Type 3

Many majors and/or one critical findings are likely to lead to CMT or IAG referral, Type 3 letters have a 14-day response timeline

Type 4

More than 1 critical finding would likely lead to automatic IAG referral and would have a 7-day response timeline. Companies receiving a type 4 letter are at high risk of licence suspension or revocation.

Dave went on to explain that if a CMT response is inadequate, escalation to IAG is almost certain. The overarching aim is always to return the company to compliance, with revocation reserved for organisations unwilling or unable to ensure ongoing safety and compliance.

 

Constructing Effective Response Letters

Dave emphasised the requirement to prepare careful, systematic preparation of MHRA inspection responses. His key recommendations included:

·         Consider the root cause and wider systemic implications

·         Set realistic timelines, overly long timelines for remediation may trigger a licence suspension by the MHRA

·         For any longer-term remediation actions e.g, a full overhaul of the quality management system, ensure you outline what interim controls will be in place to ensure compliance whilst remediation works are actioned

·         Raise deviations and change controls to formally document the issues raised in the inspection letter

·         Consolidate multiple, related deficiencies into fewer deviations to streamline CAPA management

·         Do NOT send evidence with your response letter unless specifically requested by the inspector

·         Submit your response in clearly set out Word format, ideally, use the MHRA inspection letter content with your response in a different colour font beneath each deficiency

·         Remember to respond to all deficiencies, including any ‘others’

·         Seek expert support, such as GDP consultancies like Paradigm Shift Consulting, where appropriate. Remember the sooner the consultancy is engaged the better

·         Conduct deep-dive audits when critical deficiencies are identified

·         Maintain a master list of deviations, CAPAs, change controls and timelines (this is to aid the management of actions internally, do not send to MHRA unless requested)

·         Avoid knee-jerk responses, use the full response window thoughtfully

·         Ensure CAPAs address the true root causes of the deficiencies, not just the symptoms

·         Include a robust, targeted training plan for any updated or newly created procedures as a result of the inspection letter

Dave highlighted that Paradigm Shift Consulting often get called to assist, a few days before the deadline for responding to MHRA inspection letters, leaving little time for full gap assessments, audits and QMS reviews. Dave pleaded that organisations struggling with inspection response letters to not “panic and stick your head in the sand” leaving responses to the last minute is not recommended.

 

Reducing the Risk of Poor Inspections in the Future 

Dave reiterated that long-term compliance is built on consistent and proactive governance. He highlighted some essential actions to help reduce the risk of future difficult inspections:

·         Ensure you have sufficient trained and competent personnel for all licensed activities

·         Confirm the RP has the appropriate experience and up-to-date training, including CPD and regulatory knowledge

·         Keep training records that are accurate and current

·         Perform periodic gap assessments of the entire QMS, either internally or with external consultants

·         Close out all CAPAs, deviations, change controls and complaints effectively and verify the success of the CAPAs

·         Maintain a thorough end-to-end risk assessment that is reviewed periodically and is ideally signed by senior management to demonstrate oversight and commitment

·         Document all management reviews

·         Remember: if it is not documented, it did not happen!

As Dave’s session drew to a close, one message resonated throughout the room: Good GDP is not built on documents alone, but on people, culture and continuous oversight. Insights shared by Dave in his session reinforced the importance of proactive governance and genuine quality ownership at every level of the organisation. With the knowledge and tools provided by Dave, attendees leave the conference better equipped to handling inspection outcomes and remediation.

 

Registering for the 2026 Conference

There are discounted tickets available for UK GDP Association members, members can save £100 when attending both conference days. However, our commitment to low-cost, high-value educational content means that conference tickets will still be the best value whether you chose to join as members or not.

Membership is only £29 +VAT per individual, per year and offers reduced costs on consulting, training and conference tickets. If you buy tickets for both conference days, there is an even greater discount. Costs for non-members is just £224.50 per day, a fraction of the cost of other industry events!

In addition, on the evening of Tuesday 16th June, we will be hosting an evening event of dinner, networking, and even some of Dave’s infamous karaoke, for just £49 +VAT per person. This is a fundraising dinner in aid of the MVA Society.

Please see here for more information on the conference and to book your conference and evening dinner tickets.

We are very much looking forward to seeing you all at the conference!