Joint Professional Bodies QP Symposium 2024

Future Proofing the QP Role

EPiC will be attending the Joint Professional Bodies QP Symposium 2024 on 15th May 2024.

Hosted by the Royal Pharmaceutical Society, Royal Society of Biology and Royal Society of Chemistry, the JPB QP Symposium brings together peers across pharmacy, chemistry and biology. The theme of the symposium will be on “Future Proofing the QP Role” and the event is aimed at eligible QPs and trainee QPs. 

Our Managing Director, Richard Andrews will be presenting on ‘Qualified Persons in an Ever-changing World’  This presentation will highlight and explore the world in which QPs are now required to operate, giving consideration to areas such as product and technological developments, post-COVID practices, global supply chains and expanding regulations and guidance. Insights into the challenges faced by QPs in navigating this complex environment will be presented, along with thoughts on how they can be overcome. Points for trainee and practising QPs to consider in order to ensure they are fulfilling the requirements of their role, as well as their own potential, in an ever-changing world. 

Making Pharmaceuticals Conference 2024

The EPiC Team

Pharma Discovery to Distribution

The EPiC team were pleased to be able to attend the UK’s Making Pharmaceuticals Conference 2024 in Coventry from 23rd to 24th April 2024.

The two-day conference covered topics spanning the entire product lifecycle, from discovery to distribution, and it was a fantastic opportunity to explain and promote our services to the conference attendees as well as meet with many of our current and past clients

EPiC delivered two presentations at the event. Darren Jones presented ‘Annex 1—Current & Future Deficiencies’, which identified areas where the pharmaceutical Industry routinely failed to comply with the previous Annex 1 and looked ahead to predict the potential compliance ‘pitfalls’ within the revised guidance and how to avoid these. 

Lewis Corbett presented on ‘Inspection Readiness’, which covered what being inspection-ready means in practice based on insights from former MHRA Inspectors. It highlighted expectations for PQS documentation, completion of operational activities, and examples of how to leverage output from the PQS to confirm GMDP compliance and prepare for a regulatory inspection.

The conference brought together industry leaders, professionals, and experts to share knowledge, insights, and innovations in the pharmaceutical field. Attending this event was an opportunity to engage in meaningful conversations, learn about developments in the industry, and contribute to ongoing advancements in healthcare.

We’ve already signed up to attend again next year, so be sure to save the date and join us on 29th and 30th April 2025!

EU GMP Inspection Readiness: Path to Success

Following on from the how to prepare for a regulatory inspection advice we shared during our recent virtual symposium, one of EPiC’s GMP consultants has recently returned from helping a client in California with their inspection readiness activities in preparation for the site’s first EU GMP regulatory inspection.

The on-site consultancy support provided the opportunity for the inspection hosts and subject matter experts (SMEs) to gain an appreciation of the EU GMP inspection process style and what to expect. It highlighted general points for all staff as well as some specific Do’s and Don’ts.

Newfound Confidence

The visit provided recommendations for the management of the inspection with respect to hosting, tour, and the ‘back room’ logistics and provided the opportunity to practice the inspection document request system. The facility tour focused on identifying key GMP issues so that the consultant could work with the SMEs to develop recommendations to address any issues and provided an opportunity for the SMEs to practice presenting information to an inspector.

The client reported that our consultant had been “an amazing asset by highlighting some gaps, conveyed the likely criticality of those gaps, and provided recommendations on how to address.” The inspection readiness support has given the site a newfound confidence to approach the inspection with a realistic yet positive mindset.

The client reported that “whilst we know we will have some observations, we now feel confident that the site will show well and will be able to demonstrate that we are in a state of control”, which all bodes well for a successful inspection outcome.

Are you Inspection Ready?

Take a look at our recent top-tip article by Michelle Yeomans focusing on Inspection Readiness to help you stay calm and be prepared!

Get in touch if you want to know more about our mock inspections or bespoke inspection readiness training by using our contact form here: Contact Us

EPiC Top Tips – Pharmaceutical Inspection Readiness

“Keep Calm and Be Prepared” – Inspection Readiness Top Tips

Article By Michelle Yeomans Operations Manager for EPiC Auditors

Judging by the number of enquiries we are receiving to provide ex MHRA Inspectors to assist with inspection readiness preparations or remediation activities; it certainly looks like the number of regulatory inspections and supplier due diligence audits are returning to pre-pandemic levels.

Inspections are an opportunity to demonstrate compliance, so when you receive notification of a regulatory inspection (or external audit), keep calm, and use our top tips to help be prepared:

  1. Inspection Scope  – Make sure that the purpose and scope of the inspection are clearly understood to help identify the relevant people, products, premises, systems, processes, and procedures that are likely to be involved so that these can all be factored into an inspection readiness plan. As part of the plan, consider the need for inspection awareness training for staff likely to be directly involved, especially if they have not previously experienced a regulatory inspection. Do not forget to check any contractual agreements, as contract acceptors may be required to notify the contract giver of any regulatory inspections.  
  1. Compliance Status – Leverage output from the pharmaceutical quality system by referring to performance and trend data from self-inspections, deviations and CAPA, risk assessments, management review, etc. to understand how the quality system and operational processes are performing. This will either give you assurance that you are inspection ready or help identify specific compliance concerns or weakness to enable you to focus on implementing mitigating actions.  
  1. Front and Back Room Organisation – Based on the scope and purpose of the inspection, identify and assign appropriate numbers of personnel (including deputies) to act as hosts, tour guides, scribes, runners, back-room staff handling document requests, and subject matter expects (SMEs). Provide some basic inspection preparation awareness training to give an overview of the inspection process and ensure everyone involved has a clearly defined role and purpose. 
  1. Turning Negatives into Positives – In completing your inspection readiness plan you may have identified potential deficiencies or there may be questions you would not want an inspector to ask. Encourage the SME’s who know the areas of weakness to practice explaining in a clear and succinct way what the issues are and what is being done to improve the situation. Being able to clearly explain the issues, mitigating actions and CAPA already in place can help to reassure the inspector that a situation is under control and may avoid or reduce the severity of a deficiency.    
  1. First Impressions Count – Get the inspection off to a positive start by anticipating likely questions and areas of interest and have documentation and premises ready for inspection.  Prepare a brief presentation covering site activities and confirm any significant changes since the previous inspection (if it is not the first inspection). Check that previous inspection actions have been closed and have evidence of closure to hand. Identify and walk the physical inspection routes and tidy the areas focusing on housekeeping and first impressions. Plan to walk the expected route each day to check on housekeeping, as new deliveries may have arrived, new production batches set up, new teams on shift, etc.   

By following these tips, you can prepare for an inspection by using practice runs and role-play scenarios to practice hosting, tracking, and responding to questions (including the difficult ones!) and help build confidence in being able to demonstrate compliance. 

Get in touch if you want to know more about our mock inspections or bespoke inspection readiness training.  

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

 

EX MHRA GMP INSPECTOR PHILIP ROSE JOINS THE EPIC TEAM

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

Ex MHRA inspector

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