Archives June 2023

EX MHRA GMP INSPECTOR ALAN MOON JOINS THE EPIC TEAM

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

Ex MHRA

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

EPiC Top Tips – Self-Inspection

 “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.   
  1. 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.​ 
  1. 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​. 
  1. 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. 
  1. 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 atenquiries@epic-auditors.com