Richard Andrews, Managing Director and Senior Consultant, EPiC Auditors
The UK’s pharmaceutical industry is replete with a myriad of regulations and guidelines that the companies that market, manufacture, and distribute medicinal products must comply with. During the covid-19 pandemic, these companies’ focus has rightly been on providing safe, effective, and life-saving medicines that are of the right quality to meet patients’ needs. To support them in achieving this whilst staying abreast of these guidelines and regulations, UK’s pharma businesses are seeking assistance from GXP auditing and consultancy service providers. Amongst the plethora of such companies in the UK, one name that cuts through the noise is Ex- Pharmaceutical Inspectors Consortium Limited– EPiC Auditors.
The organization possesses the skill sets to not only help such companies meet the demands brought about by the unprecedented pandemic but also advise and prepare them for compliance with emerging and continually evolving regulatory requirements. As opposed to other consultancy firms, EPiC comprises a management team of experienced ex-MHRA regulatory inspectors who offer pharmaceutical companies their comprehensive expertise. The company specialises in the pharma and biotech domain, offering consultancy services related to the medicines regulations and good practice guidelines covering good clinical practice (GCP), good manufacturing practice (GMP), good distribution practice (GDP), and good pharmacovigilance practice (GVP).
Owing to their extensive regulatory experience and pharmaceutical skillsets, EPiC’s consultants fully understand their clients’ diverse needs and advise the best course of action in addressing challenges and making their operations compliant with MHRA and EU regulations and guidelines. Whilst working for the MHRA, EPiC’s consultants performed numerous inspections and many were engaged in the drafting of new and revised GXP guidelines and regulations and worked with European and international working groups and the UK’s Department of Health, which are key factors supporting the success of their consultancy services. Being a consortium of ex-MHRA regulators, EPiC can proactively resolve its clients’ issues, distinguishing it from the rest of the players in the market, and a vivid example of that is its mock MHRA inspection services.
EPiC prepares its clients in advance for the rigorous inspections they must undergo to demonstrate compliance with regulatory guidelines and ensure they remain licensed and operative. Shedding light on this, Richard Andrews, Managing Director, and Senior Consultant at EPiC Auditors, says, “We give organizations the insights into how the inspections are actually conducted. In mock inspections, not only are areas of deficiency against the regulations and GXP guidance identified but the clients and their staff also learn how to interact with the inspectors.”
EPiC’s consultants grade the deficiencies in their criticality, the same way MHRA regulators do, and offer assistance and training to clients in taking remediation and corrective actions, fundamentally making their operations more compliant. Apart from readying clients for actual inspections, EPiC also offers post-inspection remediation services to organizations that have been found to be non-compliant by the regulator during their respective inspections, even those with their licenses suspended. In such cases, EPiC’s consultants assist the clients in resolving their deficiencies and implementing corrective measures that promote sustained compliance and prevent further suspensions. To elaborate on this, Richard recalls an incident where EPiC helped an organization to get its suspension lifted.
The client had their manufacturing license suspended by MHRA due to repeated major deficiencies. Though the organization had received deficiencies on multiple occasions, it primarily lacked a holistic methodology for identifying the root cause to properly address them. The company called EPiC and a team conducted a complete gap analysis across their pharmaceutical quality system, comprehensively examining the client’s compliance with the GMP and GDP guidelines. This led to the development of a longterm compliance improvement plan, which the client then shared with regulators. The team also ensured that the senior management had the appropriate overview, diligence, and vigilance to implement the required changes efficiently. As a result, the MHRA inspectors found the organization compliant and lifted the suspension. EPiC empowered the client to improve their quality system and foster sustainable compliance methodologies in their operations.
EPiC works with organizations to develop their organizational culture to ensure product quality and patient safety are key features of their operational approach, which in turn promotes regulatory compliance. “We encourage our clients to constantly improve their operations. We encourage them towards aiming for higher operational standards, ensuring not just minimal compliance but best practices,” elaborates Richard. Looking ahead, EPiC aims to expand its GXP services and provide more ex- MHRA inspectors an opportunity to leverage their expertise and use it to help organizations that are struggling.
We encourage our clients to constantly improve their operations. We encourage them towards aiming for higher operational standards, ensuring not just minimal compliance but best practices
EPiC is pooling its consultants’ knowledge and experience and providing bespoke training services to its clients as part of its latest endeavors. The firm recently conducted its first GMP Symposium, a ‘back-to-thepresent’ themed virtual event where its experts shared their knowledge regarding regulatory updates, helping medicinal product manufacturers and distributors to stay abreast of the latest trends in the compliance domain. Determined to bridge the gap between pharmaceutical companies and the regulatory bodies, EPiC Auditors is ideally placed to provide the knowledge, skills, and experience to drive sustainable compliance across UK’s and Europe’s pharmaceutical and biotechnology industries.