The European Forum for Good Clinical Practice (EFGCP) are hosting a half day seminar this autumn on regulatory and ethical hot topics including practical considerations for ICH GCP E6(R3) Renovation, Investigational Medicinal Product (IMP) Regulations (EU and UK IMP considerations for compliance), an update from the MHRA GCP Inspectorate and ethical discussions on consent modernisation.

EPiC Auditors are pleased to support the event hosted by the Quality Working Party. Pharma compliance expert Michelle Yeomans will be delivering a presentation on the Clinical Trials Regulation transition and the implications for IMP management to ensure compliance. We believe in the importance of collaboration and knowledge exchange in the field of clinical trials to improve and protect public health.

The virtual seminar takes place on Monday, September 11th, 2023, and brings together leading experts and stakeholders to discuss practical considerations, updates, and ethical debates that are at the forefront of the industry.

To see the full agenda and register please visit the EFGCP Website.

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

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

 “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.   

2. 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.​ 

3. 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​. 

4. 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. 

5. 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 at enquiries@epic-auditors.com

Lewis Corbett joins EPiC as Business Manager & Senior Consultant

EPIC Auditors are delighted to announce that Ex MHRA Inspector Lewis Corbett has joined EPiC Auditors as Business Manager and Senior Consultant.

Lewis has over 25 years experience of pharmaceutical manufacture and distribution gained from working within the industry and for the GMP Inspectorate of the UK medicines regulator (MHRA) as a Senior GMP Inspector and Head of GMP Team 1. During his 5 years at the MHRA Lewis had responsibility for the licensing and inspection of pharmaceutical manufacturers and distributors both in the UK and overseas, managing and leading a team of GMP Inspectors, implementing changes to regulations and ways of working as a result of EU Exit, and supporting elements of the agency’s Covid-19 pandemic response. 

Prior to joining the MHRA Inspectorate Lewis spent 22 years working in the pharmaceutical industry in various QC, QA and management roles, and as a Qualified Person for a range of active pharmaceutical ingredients and non-sterile product dosage forms.

Lewis was trained and accredited by the MHRA to inspect:

• API manufacturers, importers and distributors  
• Importation of medicinal products 
• Non-Sterile manufacturing sites   
• Contract laboratories   
• Excipient manufacturers  
• Storage and distribution sites

He has expertise in MHRA and EU Inspection preparation and remediation, Pharmaceutical Quality Management Systems, and training in EU GMP Regulatory requirements and is eligible to act as an EU Qualified Person.

With his wide portfolio of experience, Lewis is a great addition to the core EPiC team and with his help we are confident we can extend our GXP support across the medicinal product lifecycle and help all our clients to improve their GXP quality systems and regulatory compliance.

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

EPiC Auditors Autumn Compliance Seminar: Thursday 10th November 2022

Here’s what our seminar speakers have to say about the event;

“A condition of holding an MIA and WDA(H) is that the guidelines on GMP and GDP are complied with. Sustaining the required level of compliance is a must to ensure medicinal products of the right quality are manufactured and distributed and avoid regulatory action. My presentation on Future-proofing compliance will explore what licence holders can and should do to continually improve and not only fulfil but exceed this requirement.” 

Richard Andrews, EPiC Auditors Managing Director & Senior Consultant   

With the deadline for the implementation of Annex1 fast approaching, now is a great time to consider the implications for your sterile processes.  At the EPiC Autumn Compliance Seminar, I will roadmap those areas of the new Annex 1 that may result in many future sterility assurance deficiencies – a roadmap of the hotspots. This session will complement the session from Rick Parker of the MHRA, who will provide the latest MHRA thinking on Annex 1. A great opportunity to get ahead of the Annex 1 changes!

Darren Jones, EPiC Auditors Director & Senior Consultant

To find out more about the seminar and to book your tickets click on the link below:

What was it?

This online seminar was a full day delivered remotely comprising a variety of ex MHRA Inspector speakers with invited guest speaker Richard Parker, Senior GMDP Inspector at the MHRA who will be delivering an MHRA update on Annex 1 with a regulators view of the changes. 

Altogether was a thought-provoking and informative day which aimed to:

• Share recent changes and updates to the GMP and GDP Guidelines and Regulations with particular focus on Annex 1.
• Highlight changes to inspection practices and MHRA oversight.
• Discuss tools and practices to maintain compliance.
• Present current and future Annex 1 deficiencies, along with the pitfalls to avoid.
• Provide insight into the changes arising from the implementation of the Clinical Trials Regulations and points to consider around the IMP / GCP Interface.
• Explore the challenges and considerations when moving from an R & D to a GMP Environment.

This event provided updates and information on recent changes to guidelines and regulations as well insights into current deficiency trends and inspection practices.