EX MHRA GMDP INSPECTOR IAN REES JOINS THE EPIC TEAM

pharmaceutical compliance

EPiC Auditors are thrilled to announce that Ian Rees, a renowned pharmaceutical compliance expert and former Expert MHRA GMDP Inspector, has joined our team as an independent consultant.

With an impressive career spanning over 40 years, twenty of which were with the MHRA, Ian brings a wealth of invaluable experience to our organisation. 

During his time at the MHRA, in addition to being a GMDP Inspector Ian was the Unit Manager for the Inspectorate Strategy and Innovation team, represented the Agency on the European Medicines Agency’s (EMA) GMDP Inspectors Working Group, was chair of the EMA/HMA’s Joint Audit Program (JAP) and was the MHRA representative at EU Blood Authority Meetings which regulates blood used for transfusion. 

In 2013 Ian helped to establish the MHRA’s Innovation Office and in 2014 the UK cross regulatory ‘One Stop Shop’ which provides regulatory advice and guidance to organisations developing innovative products or novel manufacturing processes.  

Prior to leaving the MHRA Ian became an assessor in the newly created Science Research and Innovation Group which incorporated the Innovation Office and was the MHRA’s representative at the Innovation Accelerator, a UK cross-industry regulatory group established to support innovations. He also led MHRA’s work in developing a new regulatory framework for distributed and point of care manufacture. 

A Vet by training Ian also has a background in veterinary medicines and was a GMP inspector at the UK’s Veterinary Medicines Directorate where he was also involved official batch release, scheduling of inspections and assessment of dossiers of immunological veterinary medicinal products. 

With his extensive expertise, Ian brings a comprehensive understanding of national and international regulatory processes, ATMPs, biologicals, and biotechnology manufacturing systems, as well as Quality Management System requirements. 

We are privileged to have Ian Rees join the EPiC team, enhancing our capabilities and expanding our consultancy services to support innovation. His exceptional track record and knowledge of the complex regulatory landscape will undoubtedly be of benefit to our clients

Richard Andrew, EPiC Managing Director & Senior Consultant  

To read the bio and full CV for Ian Rees and our other experts’ visit Meet Our Experts  

Pharmaceutical Industry Experts  

At EPiC Auditors, our expertise lies in providing comprehensive pharmaceutical compliance auditing services, regulatory compliance guidance, and expert insights to pharmaceutical companies. As a leading auditing and GxP quality assurance consultancy firm, we specialise in ensuring that the highest quality standards are achieved and maintained within the pharmaceutical industry. Our seasoned team of former Regulatory Agency professionals are committed to our mission of ensuring the safety, efficacy, and quality of pharmaceutical products, ultimately contributing to the well-being of patients worldwide. 

If you need our help and support then please contact us on +44 (0)1244 980544 or e mail us at enquiries@epic-auditors.com 

EX MHRA GMP INSPECTOR PHILIP ROSE JOINS THE EPIC TEAM

EPiC Auditors are delighted to announce that Ex MHRA inspector Philip Rose has joined the EPiC team as an independent consultant.

Ex MHRA inspector

Ex MHRA inspector Philip has over 20 year’s pharmaceutical industry experience gained from his time working within the industry and through working for the MHRA for over 7 years, where he held the position of Lead Senior GMP Inspector. His expertise includes the manufacture of sterile and non sterile medicinal products, biologics, and ATMPs; inspecting and auditing nationally and internationally, training, presenting and mentoring on medicinal product manufacture and packaging and auditing and inspection of GMPs.

Philip is eligible to act as a Qualified Person and he has an in depth and current knowledge of regulatory guidance and the interpretation of it.

At EPiC, we pride ourselves on assembling a team of industry-leading professionals, and Ex MHRA inspector Philip is no exception. His extensive experience and expertise align perfectly with our commitment to excellence in auditing, regulatory compliance, and quality assurance within the pharmaceutical industry.

“Philip is highly respected within the pharmaceutical industry and along with our other former MHRA Inspector consultants he will be key in helping EPiC to deliver quality assurance services to our clients, ensuring they are compliant with all aspects of their operations. Having Philip as part of the EPiC team will be invaluable as we continue to develop our business.” 

Richard Andrew, EPiC Managing Director & Senior Consultant

To read the bio and full CV for Philip Rose and our other experts’ visit Meet Our Experts 

Pharmaceutical Industry Experts 

EPiC Auditors is a leading auditing and quality assurance consultancy firm specialising in the pharmaceutical industry. With a team of seasoned professionals, we provide comprehensive auditing services, regulatory compliance guidance, and expert insights to help pharmaceutical companies achieve and maintain the highest quality standards. Our mission is to ensure the safety, efficacy, and quality of pharmaceutical products, ultimately contributing to the well-being of patients worldwide.

If you need our help and support then please contact us on +44 (0)1244 980544 or e mail us at enquiries@epic-auditors.com 

EPiC Top Tips – Assessing the Effectiveness of Training

Measuring Success – Top Tips for Assessing the Effectiveness of Training

Article By Michelle Yeomans Operations Manager for EPiC Auditors

effectiveness of training

The Covid-19 pandemic led to changes in the amount and delivery method used by Pharmaceutical companies to conduct training. Some companies cut back on training to conserve resources for core functions, whilst others invested in virtual training and e-learning to provide continued development opportunities for their employees. The situation was no different for regulators.

During the pandemic, I was the Unit Manager of the GMP and GDP Inspectorate at the MHRA, and as well as developing remote inspection approaches to ensure a continued level of regulatory oversight, MHRA used the opportunity to dedicate Inspectorate resource to enhance the range of training materials available within the ‘Inspector Academy’ knowledge hub and developed virtual training modules and competency frameworks. At the time, it was a case of adapting to the situation and being innovative in exploring available tools and techniques to identify the “least worst” available option.

Post pandemic, several conferences and training events have now returned to being run as face-to-face events, while others are continuing to offer virtual or hybrid options to maximise accessibility and minimise costs. EU GMP Chapter 2, 2.11 refers to the need for “continuing training” to be given and for its “practical effectiveness” to be periodically assessed. Continuing training is an ongoing process of learning and acquiring new skills and knowledge to help individuals stay updated with the latest developments and changes relevant to their role and industry sector. Continuing training can include self-learning so is not just limited to attending workshops, seminars, conferences, or specialist courses. The key point is finding a way to stay current with industry trends, which will help increase expertise and proficiency and support compliance with GMP requirements. Another key consideration is the need to keep a record to document the training, as training records are routinely reviewed during a regulatory inspection and provide evidence of continuing professional development.

With different training opportunities and formats on offer, it is important to have clearly defined learning objectives and ways of collecting information to determine whether the training provided has produced the desired effect and contributed to the development of the trainee.

Here are our top tips for assessing the practical effectiveness of training:

  1. Pre and post-assessments: Conducting assessments, questionnaires, or quizzes before and after the training can help measure the knowledge, skills, or behaviour changes that have occurred as a result of the training. Comparing the scores or performance levels before and after the training provides an indication of the impact of the training.
  2. Observations and simulations: Observing participants during or after the training session can help assess their application of the newly acquired knowledge and skills. This can be done through simulations or real-world scenarios to evaluate their ability to transfer the learning into practical situations.
  3. Follow-up assessments: Conducting assessments weeks or months after the training has taken place can help evaluate the long-term impact and effectiveness of the training. This can provide insights into whether the learning has been retained, and if it has influenced the individual’s work performance over time.
  4. Feedback: Soliciting feedback from trainees and supervisors or managers who work closely with the individuals can provide an additional perspective on the effectiveness of the training. They can assess whether the training has positively impacted the individuals’ job performance, productivity, or overall contribution to the organisation.
  5. Performance metrics: Comparing PQS performance, KPIs or Quality metrics before and after the training can yield insights into any improvements or changes in the workplace performance of individuals or teams who participated in the training. An overview of GMP related training completed, and a review of PQS performance to identify compliance improvement topics for inclusion in further GMP refresher training should be included as agenda items at periodic Management Review meetings.

By using a combination of these assessment methods, organisations can gain a comprehensive understanding of the effectiveness of their training efforts and identify areas for improvement.

Please get in touch if you want to know more about our virtual symposia and bespoke in-house training courses.

Telephone: +44 (0)1244 980544 or email us at enquiries@epic-auditors.com 

EX MHRA GMP INSPECTOR ALAN MOON JOINS THE EPIC TEAM

We are thrilled to welcome Ex MHRA Inspector Alan Moon as an Independent Consultant at EPiC Auditors.

Ex MHRA

Alan Moon began his career in the pharmaceutical industry in February 1994 and has extensive experience of pharmaceutical manufacture, particularly associated with sterile products and investigational medicinal products (IMPs). He spent approximately 19 years working within the pharmaceutical industry before joining the UK Medicines Regulator (MHRA) in 2013.


During his ten years at MHRA Alan reached the level of Lead Senior Inspector and in addition to supporting the GMP Inspectorate’s risk-based inspection programme and being the nominated chair for the Compliance Management Team, he was also the technical lead within the GMP team for both sterile products and IMPs.

He was the principal UK representative for the GMP Annex 1 drafting group from 2019 through to its publication in August 2022, and continued to support the associated PIC/S inspector training group and participate in conferences on the subject until leaving the Agency in March 2023.

Alan was also part of the EU working group for the revision and update to GMP Annex 13 and as part of the UK’s exit from the EU, he prepared the framework and guidance for implementation of the UK MIA(IMP) oversight process for the import of QP-certified IMPs from listed countries into Great Britain, and the associated aspects relating to the Northern Ireland Protocol.

Prior to joining the MHRA GMP Inspectorate, Alan worked in a variety of roles within the pharmaceutical industry, including QA, QC Microbiology, Sterility Assurance, Validation and Production, with significant experience of aseptic and terminal sterilisation manufacturing processes.

Alan’s exceptional skills, extensive experience, and unique expertise make him the perfect addition to our team.

QUOTE FROM RICHARD ANDREWS

We are thrilled to welcome Ex MHRA inspector Alan as an independent consultant at EPiC Auditors. Having been involved with the manufacture and regulation of medicines for nearly three decades Alan’s expertise is a key resource for the industry, and he is a great addition to the EPiC team.

Richard Andrew, EPiC Managing Director & Senior Consultant

Pharmaceutical Industry Experts

Auditors used by EPIC are former Regulatory Inspectors, typically ex MHRA Inspectors. All auditors have extensive industry experience and many years of experience auditing and inspecting within the pharmaceutical industry.

To read the bio and full CV for Alan Moon and our other experts’ visit Meet Our Experts

If you need our help and support then please contact us on +44 (0)1244 980544 or e mail us at enquiries@epic-auditors.com

EPiC Top Tips – Self-Inspection

 “Mind the Gap” – 5 Top Tips for Improved Self-Inspection

Article By Michelle Yeomans Operations Manager for EPiC Auditors

During our time as MHRA Inspectors and now as pharmaceutical consultants, at EPiC we routinely see non-compliant sites i.e., those referred to MHRA’s Inspection Action Group (IAG) with a series of self-inspection reports indicating a high level of compliance. This begs the question why do some self-inspection programmes fail to adequately appraise the effectiveness and applicability of pharmaceutical quality systems (PQS)? 

Here are our top tips on how to avoid gaps between self-inspection and regulators findings: 

  1. Remember why you are performing self-inspections Self-inspections are often not taken as seriously as regulatory inspections, but ultimately have the same objective to protect patients and product quality. Self-inspections can help identify and address deficiencies to support maintaining an “inspection ready” status by providing confidence that you as a licence holder are meeting your legal obligations to comply with EU GMP and GDP requirements.   
  1. Self-inspection perception – Unless sufficient time and resources are allocated to self-inspection, programmes can become too informal and rushed. Taking the time to objectively evaluate a process, facility, or document should be seen as value adding by providing an opportunity to gather information about compliance and is a way for Senior management including QPs/RPs to have oversight of the performance of all areas of the business.​ 
  1. Self-inspection focus – Consider whether audits should be horizontal audits i.e., follow the process flow from goods receipt to product release for example or be focussed on just one area of the process.​ Use a risk-based approach by researching the most common deficiencies found during inspections and audits e.g., consider examples which are published by MHRA, or featured in EPiC Seminar presentations, to ensure “hot topics” are include as an area of focus during the audit. Identify the high-risk areas of the process which will require more of your attention. This can be done by looking at the past performance of the area – deviations, change controls, previous audit findings etc​. 
  1. Invest in Auditor training – Audits drive big decisions such as capex, awarding contracts, supplier approval, compliance level assessment, etc. so it is important auditors are trained. This includes having an understanding and ability to apply a broad range of softer behavioural and questioning skills, follow good practice guidance on the principles of auditing, and can demonstrate an understanding of the applicable GXP rules and regulations. 
  1. Post audit activity – It’s not all about performing the audit, it is equally important to maintain a focus on CAPA completion and ongoing effectiveness checks. Successful completion of CAPA is integral to achieving the objective to protect patient and product quality and drives sustainable compliance. 

By following these 5 tips, you can improve the effectiveness of self-inspections, ensure that the PQS is continuously improving and “mind the gap” between self-inspection and regulatory findings! 

Get in touch if you want to know more about our bespoke inhouse training course on effective and value adding self-inspection and how we train auditors.  

Call to speak to one of our pharmaceutical consultants: +44 (0)1244 980544 or email us atenquiries@epic-auditors.com