Vicki Pike Will Join The EPiC Management Team as Operations Manager & Senior Consultant

EPiC Auditors is delighted to announce that Vicki Pike will be joining us on the 11^th November to take up the role of EPiC Auditors Operations Manager and Senior Consultant. 

EPiC Auditors is celebrating its 10 year anniversary this year having been established in 2014 by Liz Allanson and Darren Jones (both ex MHRA) to fulfil the increasing need for former MHRA Inspectors to conduct mock regulatory inspections and to provide consultancy advice from the Regulatory perspective. Since then, the company has developed significantly, and Vicki has been appointed to further strengthen the EPiC management team and our team of consultants.

Vicki joins us with over 25 years experience of working in the pharmaceutical industry, including 7 years working as a GMDP Inspector for the MHRA where she was accredited to perform a wide range of inspections of different dosage forms and processes including: steriles, non-steriles, specials (unlicensed medicines), medical gases, IMPs, herbals, importation and wholesale dealing.

Prior to joining the MHRA, Vicki worked for AstraZeneca at their UK manufacturing site, predominately in Quality roles, and became eligible as a QP in 2006. After leaving MHRA Vicki joined GlaxoSmithKline, where she worked as a corporate auditor for 8 years, and latterly led a remediation project at a European manufacturing site.

Vicki is a Pharmacist by training and puts patient impact at the forefront of her decision making. Vicki is passionate about sharing her knowledge, especially when coaching and training others.

We are really excited about Vicki joining the team and acknowledge the range of skills and experience she brings which will help us to develop further and extends our capabilities to meet the needs of all our clients.

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

WOULD YOU LIKE TO JOIN AN EPiC TEAM?💫

EPiC Auditors is looking to strengthen our Management Team and grow our dynamic team of GXP Consultants.

EPiC Auditors is one of the leading pharmaceutical consultancies in the UK. It provides expert GXP Auditing, mock Inspection, consultancy, and bespoke training services to the pharmaceutical industry worldwide, as well as to pharmaceutical manufacturing and clinical trial services in hospitals.

As demand for our services continues to grow, we are looking to recruit an Operations Manager and also a GMDP Senior Consultant.

EPiC is passionate about ensuring a healthy work-life balance and maintaining an enjoyable work environment, achieved through flexible working patterns. Both posts are home based but do require travel throughout the UK and overseas.

This is a great opportunity to join a team of experts many of whom are former MHRA inspectors. Our consultants bring their wealth of experience to EPiC, ensuring that our clients receive world class guidance and solutions.

If you meet the role requirements and want to be part of a team who have first-hand knowledge of regulatory inspections and compliance and are passionate about making a difference in the pharmaceutical industry, we encourage you to apply!

The closing date for applications for both posts is 14^th September 2024

Getting to the Root of the Problem – 5 Top Tips for Root Cause Analysis & Investigations

Article By Michelle Yeomans, Operations Manager for EPiC Auditors

During my time as MHRA GMDP Inspectorate Operation Manager part of my role involved taking overall responsibility for planning and delivery of the annual MHRA GMP Symposium.

Year on year delegates would request an update on deficiency data and examples of the most cited deficiency topic areas. And year on year the most common deficiency references related to Pharmaceutical Quality System (PQS) and Documentation requirements.

This may not be surprising given that regardless of the size, complexity, and licence type of the site being inspected, all are expected to have a PQS and associated documentation, and at least some of the elements of the PQS will always be inspected.

Is it therefore, inevitable that all GMP inspections are destined to receive a PQS-related deficiency, or is it possible to buck the trend by getting to the root of the problem?

A closer look at the latest MHRA deficiency data from 2019 Good Manufacturing Practice Inspection Deficiencies – GOV.UK (www.gov.uk), and from EPiC’s own experiences of providing pre-inspection and remediation support, shows EU GMP Chapter 1 reference C1.4(xiv) relating to poor root cause investigations and ineffective CAPA as the most frequent recurring PQS deficiency.

Here are our top tips for improving root cause investigations to help you get to the root of the problem:

1. Understanding the meaning of Root Cause Analysis (RCA) – RCA is an activity intended to identify the origin or root cause of the problem. The root cause is the leading cause of the problem and may be made up of several factors. It’s essential to the identify root cause rather than just causal factors. Causal factors are contributing actions that affect an incident/event’s outcome. Removing a causal factor will be beneficial but on it’s own, won’t prevent the problem from recurring.
2. Use an appropriate level of RCA – The level of RCA undertaken should be commensurate with risk and be based on Quality Risk Management (QRM) principles. For a simple problem that presents no risk to product quality or patient safety for which there is an obvious root cause, then a simple correction to fix and document the issue can be justified without the need for RCA and additional CAPA. However more complex or recurring problems that present a potential risk to patient safety and have no obvious root cause will require in depth investigation using RCA tools and may generate multiple CAPAs.
3. Thorough documentation – RCA investigations should be thoroughly documented to demonstrate the risk-based rationale, tools, and critical evaluation of potential root causes and causal factors used to identify the root cause. The information could provide learnings for future investigations or for education and training such as examples for inclusion in GMP refresher training. Having the complete picture to hand will also help you explain in a clear and succinct way what the issues were and what is being done to improve the situation should you need to present RCA investigation data during an inspection.
4. It’s a team effort – RCA investigations should involve as many people as is reasonably practicable. Multidisciplinary teams contribute different knowledge, experience and points of view that are valuable to the investigation as they help to generate a wider range of potential root causes and causal factors and can enhance the application of critical thinking to form a judgement on the likely root cause. Sharing the issues and output from the investigation through team meetings, Quality forums, newsletters etc. can help others learn from the issue which may prevent similar issues elsewhere.      
5. PQS metric targets – Beware of setting targets e.g. 30 days to complete RCA investigations as this may drive the wrong behaviours. Although it makes sense to have a target to complete investigations as soon as possible, speed is not as important as identifying the true root cause. Meeting the target should not prevent a thorough investigation and investigations should not be stopped at an inappropriate level just to meet a target. The PQS should therefore acknowledge that complex investigations may take longer than the target and have a mechanism to document and maintain oversight.

By following these tips, you can turn the inevitable into avoidable by enhancing your RCA knowledge and investigation process, and reduce the likelihood of receiving a PQS deficiency for poor RCA investigations.

Get in touch if you want to know more about our bespoke root cause analysis and effective CAPA training.

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

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 

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

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