Which Compliance Areas Do You Find Most Challenging? 

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.

What Our Clients Say

Ensuring Excellence in GXP Compliance: Discover the EPiC Difference Through Our Client Testimonials

Our mission has always been to foster product quality, patient safety, and ensure the highest regulatory standards. But don’t just take our word for it—let our clients tell you about their EPiC journey. 

Check out our latest testimonials in this short video “What Our Clients Say” and see why EPiC Auditors is a trusted partner for pharmaceutical businesses seeking excellence in their GXP compliance needs.

WHAT DO YOU REQUIRE?

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.

If you need our help and support, then please don’t hesitate to contact us; enquiries@epic-auditors.com

Call: +44 (0)1244 980544

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

 You may also like to read our Case Study 1: Inspection Readiness: https://epic-auditors.com/case-study-inspection-readiness/