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.

Serious about Making Pharmaceuticals?

Our Directors Richard Andrews and Darren Jones will be joining GMP Healthcare Ltd on stand 220 at this year’s Making Pharmaceuticals Conference in Coventry on the 25th – 26th April 2023.

As the largest Pharmaceutical Event in the UK, it covers everything from Processing, Medical Devices, Regulatory, Clinical Testing, Research & Development, Operational Excellence, Pharmaceutical Quality, Serialisation, Clinical Trial Testing, Ingredients / Excipients, Microbiology, Pharmaceutical Engineering, Packaging & Labelling, New Technologies & Data Management.

We will be on hand to discuss any challenges you are facing and offering our expertise to help pharmaceutical and biotechnology companies, as well as other associated healthcare clients, to achieve and maintain regulatory compliance and excellent pharmaceutical quality systems, to best industry standards.

Registrations are open for your complimentary Exhibition & Conference passes. It will be great to catch up with clients and colleagues old and new. If you are attending, please come along and say hello at the Making Pharmaceuticals Conference!

WE SPECIALISE in helping pharmaceutical and biotechnology companies, as well as other associated healthcare clients, to achieve and maintain regulatory compliance and excellent pharmaceutical quality systems, to best industry standards. As ex MHRA inspectors, we know how the Regulators work and think. No consultants know how the MHRA operates better than we do.  We specialise in mock inspections; GXP audits, supply chain and system audits. We work with large organisations but also have a particular interest in supporting new and expanding small companies including wholesalers; contract laboratories and clinical development laboratories.

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 

Cyber Essentials Accreditation

This month, Epic Auditors are proud to announce that they have achieved certification from Cyber Essentials proving their dedication to guard against cyber threats and demonstrate a commitment to cyber security.

What is Cyber Essentials?

Cyber Essentials is an official UK, Government backed scheme that encourages organisations, of all sizes to adopt best practice in information security and ensures they take sufficient measures to prevent against the risks of possible threats against a whole range of cyber attacks.

This certification is awarded by means of an independent assessment of the business security controls and processes, it also gives peace of mind that company defences will protect against the vast majority of common cyber-attacks. Receiving this accreditation shows that EPiC Auditors have addressed those basics to prevent the most common attacks within their systems.

Richard Andrews, Managing Director of EPiC Auditors commented “Achieving the Cyber Essentials certification is crucial in ensuring our cyber security is as strong as possible to protect our clients’ sensitive data. Our clients can have the confidence and trust that we are following best practice guidelines and recognise the importance of keeping their information safe and our IT systems secure.”

EPIC Auditors are dedicated to investing in its cyber security and will continue to adopt best practices in their information security strategy to ensure that the data we hold is managed properly and kept in a secure and safe digital environment.

EPiC Auditors Awarded Top 5 Quality Assurance Services Companies in the UK

We are delighted to announce that EPiC Auditors have won a place in Pharma Tech Outlook’s Top 5 Quality Assurance Services Companies in the UK 2022, the annual listing of 5 companies in the UK that are at the forefront of providing Quality Assurance services and transforming businesses in the region.

Specialising in performing mock inspections, GXP audits, supply chain and system audits, delivering bespoke training and supporting post-inspection remediation EPiC Auditors help clients achieve and maintain regulatory compliance.

Comprising of an experienced group of ex-MHRA Inspectors, the EPiC management team and consultants fully understand clients’ diverse needs and can therefore advise the best course of action to address the challenges they face and make their operations compliant with MHRA and EU regulations and guidelines by providing comprehensive GXP consultancy service.

As ex MHRA inspectors, EPiC Auditors is able to bridge the gap between pharmaceutical companies and the regulatory bodies, making us ideally placed to provide the knowledge, skills and expertise to drive sustainable compliance across the UK and Europe’s pharmaceutical and biotechnology industries.

You can access the Pharma Tech Outlook Magazine Quality Assurance Edition and read the full feature article here: https://www.pharmatechoutlook.com/magazines/May2022/Quality_Assurance_Europe/?digitalmagazine