EPiC Top Tips- Implementing Effective Quality Risk Management

5 Top Tips for Implementing Effective Quality Risk Management

Article By Michelle Yeomans, Operations Manager for EPiC Auditors

Quality risk management (QRM) is an integral part of GMDP that strives to protect patients by applying a scientific and practical approach to decision-making for different aspects of pharmaceutical quality throughout the product lifecycle.

The ICH Q9 QRM Guideline is referenced in Chapter 1 of EU GMP and reproduced in Part III of the guide and is intended to provide guidance on the principles, and examples of tools for QRM that can be applied to different aspects of pharmaceutical quality.

Following the Revision 1 update of ICH Q9 which became effective in July 2023, EPiC have been providing bespoke training and supporting clients as they assess and update their own PQS procedures in line with the changes to make QRM activities more effective and value adding.

ICHQ9(R1) provides multiple examples of potential applications of QRM, and If you have not done so already, we recommend you review the training materials on the ICH Q9 webpage https://www.ich.org/page/quality-guidelines and follow our top tips for effective QRM:

  1. QRM application – QRM can be applied anywhere there is potential risk across the business and across a product’s lifecycle. In applying QRM, it is important to ensure that patient safety and product quality considerations remain front and centre, as patients are putting trust in the decisions you make. QRM cannot be used to justify bad practice and non-compliance with GMP requirements.
  2. Risk Review – Be proactive and develop mechanisms to prompt reviews of existing risk profiles and control measures as your knowledge and experience increases. For example, set aside time at Quality Management Review meetings to review risk registers, review risk assessments associated with specific manufacturing processes, perform a review of engineering activities to confirm that planned preventative maintenance is on track and equipment is performing as expected, periodically review supplier performance and changes to confirm existing risk ratings are appropriate.
  3. Adopt a QA mindset – Design your processes to deliver a quality output rather than relying on problems/defects being detected at the end of the process. Provide training in the tools and techniques to the people involved in QRM activities and consider using experienced facilitators for more formal QRM processes.
  4. Think about the people involved – subjectivity can directly impact the effectiveness of risk management activities and the decisions made, so it is important to be able to recognise and control subjectivity, bias, assumptions, and mental shortcuts. This can be achieved by ensuring that risk questions are clearly defined, appropriate QRM tools are applied, and by being objective and evidenced based when assessing data and proposed control measures.
  5. Apply critical thinking – Critical thinking requires us to actively engage our brain to be able to work out complex problems. In working through the risk assessment, risk control and risk review phases of QRM, think clearly and rationally to understand the logical connection between ideas. Use the Q9 QRM toolkit to provide a systematic approach to identify, analyse, and solve problems rather than using intuition or instinct, but be prepared to question ideas and assumptions rather than accepting at face value e.g. is the tool fit for purpose, does the output seem right?

Effective and proactive QRM can enable better, more informed, and timely decisions throughout the product lifecycle, and we hope that our top tips will provide you with some useful ideas on how to further enhance your QRM processes.  

Get in touch if you want to know more about our bespoke QRM and critical thinking training.

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

SAVE THE DATE: EPiC’s Virtual Symposium 2024 

EPiC Auditors Virtual Symposium 2024: From Complaint to Compliant: A Practical Guide to Overcoming Current GMDP Challenges

EPiC Auditors Virtual Compliance Symposium: From Complaint to Compliant: A Practical Guide to Overcoming Current GMDP Challenges
EPiC Auditors Virtual Symposium 2024: From Complaint to Compliant: A Practical Guide to Overcoming Current GMDP Challenges

Join us for EPiC’s fourth annual virtual symposium on Thursday, 28th November 2024, titled “From Complaint to Compliant: A Practical Guide to Overcoming Current GMDP Challenges.”

Building on the success of our past symposia, this event promises a day packed with enlightening presentations by a distinguished panel of former MHRA Inspectors. We’ll explore the latest updates and guidance and provide practical guidance to conquer compliance challenges facing the pharmaceutical sector.  Further details to follow!

Subscribe to our newsletter to receive exclusive updates and all the latest news on EPiC’s Symposium 2024.

EX MHRA GMDP INSPECTOR IAN REES JOINS THE EPIC TEAM

pharmaceutical compliance

EPiC Auditors are thrilled to announce that Ian Rees, a renowned pharmaceutical compliance expert and former Expert MHRA GMDP Inspector, has joined our team as an independent consultant.

With an impressive career spanning over 40 years, twenty of which were with the MHRA, Ian brings a wealth of invaluable experience to our organisation. 

During his time at the MHRA, in addition to being a GMDP Inspector Ian was the Unit Manager for the Inspectorate Strategy and Innovation team, represented the Agency on the European Medicines Agency’s (EMA) GMDP Inspectors Working Group, was chair of the EMA/HMA’s Joint Audit Program (JAP) and was the MHRA representative at EU Blood Authority Meetings which regulates blood used for transfusion. 

In 2013 Ian helped to establish the MHRA’s Innovation Office and in 2014 the UK cross regulatory ‘One Stop Shop’ which provides regulatory advice and guidance to organisations developing innovative products or novel manufacturing processes.  

Prior to leaving the MHRA Ian became an assessor in the newly created Science Research and Innovation Group which incorporated the Innovation Office and was the MHRA’s representative at the Innovation Accelerator, a UK cross-industry regulatory group established to support innovations. He also led MHRA’s work in developing a new regulatory framework for distributed and point of care manufacture. 

A Vet by training Ian also has a background in veterinary medicines and was a GMP inspector at the UK’s Veterinary Medicines Directorate where he was also involved official batch release, scheduling of inspections and assessment of dossiers of immunological veterinary medicinal products. 

With his extensive expertise, Ian brings a comprehensive understanding of national and international regulatory processes, ATMPs, biologicals, and biotechnology manufacturing systems, as well as Quality Management System requirements. 

We are privileged to have Ian Rees join the EPiC team, enhancing our capabilities and expanding our consultancy services to support innovation. His exceptional track record and knowledge of the complex regulatory landscape will undoubtedly be of benefit to our clients

Richard Andrew, EPiC Managing Director & Senior Consultant  

To read the bio and full CV for Ian Rees and our other experts’ visit Meet Our Experts  

Pharmaceutical Industry Experts  

At EPiC Auditors, our expertise lies in providing comprehensive pharmaceutical compliance auditing services, regulatory compliance guidance, and expert insights to pharmaceutical companies. As a leading auditing and GxP quality assurance consultancy firm, we specialise in ensuring that the highest quality standards are achieved and maintained within the pharmaceutical industry. Our seasoned team of former Regulatory Agency professionals are committed to our mission of ensuring 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 

EPiC’s Autumn Compliance Seminar

Registrations are now open for EPiC’s Autumn Compliance Seminar:

Thursday 10th November 2022

compliant future

Shaping a Pharma Compliant Future

After the success of our GMP Symposium in February, EPiC Auditors are pleased to announce that we will be delivering a virtual compliance seminar on Thursday 10th November 2022.

The theme is Shaping a Pharma Compliant Future – How to achieve and demonstrate sustainable compliance.

This online seminar will be a full day delivered remotely comprising a variety of ex MHRA Inspector speakers with an invited guest MHRA GMDP Inspectorate speaker. Altogether it will be a thought-provoking and informative day!

The outline agenda includes;

  • Recent Updates to Guidelines and Regulations
  • Assessing and Demonstrating Compliance
  • Tools to maintain compliance
  • Current and future Annex 1 deficiencies
  • The IMP/GCP interface
  • Future-proofing compliance
  • Considerations when moving from R&D to GMP
  • GDP controls and expectations for importation

**Re-visit our website here to see the full the details and agenda as it develops**

You can now buy your EPiC Autumn Compliance seminar tickets for £250 + VAT

Click on the button below to register and pay online:


In collaboration with SeerPharma UK

pharma compliant future

You may also be interested in the SeerPharma UK GDP Symposium taking place on Tuesday 8th November 2022: Register and Pay Online Here