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

EPiC Virtual Symposium 2024

EPiC proudly presents our full-day virtual symposium event featuring an esteemed lineup of former MHRA Inspector speakers.

📅Join us on Thursday, 28th November 2024, for our event;

FROM COMPLAINT TO COMPLIANT: A PRACTICAL GUIDE TO OVERCOME CURRENT GMDP CHALLENGES. 💊💊

We will explore the latest regulatory updates and guidance and provide practical guidance to conquer compliance challenges facing the pharmaceutical sector.

Our objective is to combine valuable insights using real-world examples and experiences from across our consortium of expert pharmaceutical consultants to provide the knowledge and offer practical solutions to overcome current GMDP compliance challenges.

For more information and to buy your ticket click on the link below;

EPiC Auditors Virtual Symposium 2024: From Complaint to Compliant: A Practical Guide to Overcoming Current GMDP Challenges

Join us for EPiC’s fourth annual virtual symposium on Thursday, 28th November 2024, titled “From Complaint to Compliant: A Practical Guide to Overcoming Current GMDP Challenges.”

Building on the success of our past symposia, this event promises a day packed with enlightening presentations by a distinguished panel of former MHRA Inspectors. We’ll explore the latest updates and guidance and provide practical guidance to conquer compliance challenges facing the pharmaceutical sector.  Further details can be found here; https://academy.epic-auditors.com/

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GXP Compliance Challenges

The constantly evolving landscape within the pharmaceutical industry presents a myriad of challenges, especially when it comes to compliance. Across the GXP’s the range of compliance areas is vast and varied.

Your experiences and insights are invaluable to us, as they help us customise our services to better address the real-world challenges you face. Your feedback will shape our future symposia, articles and top tips, ensuring we focus on the areas that will most benefit your operation.

Please let us know which aspects of regulatory compliance you find most challenging and why and share your thoughts and ideas about the compliance hurdles that have the greatest impact on your business.

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