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

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

Thursday 10th November 2022

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

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

We are very pleased to announce that Michelle Yeomans, GMDP Inspectorate Unit Manager at the MHRA will be delivering a Regulatory Update at the forthcoming GMP symposium.

Michelle will be covering the Clinical Trials Regulation and what it means to the UK, share the latest on the NI Protocol and the discussions with the EU, give an update on the transformation of the agency and highlight the top 10 deficiencies arising from GMP Inspections during 2021.

On receiving confirmation of Michelle’s participation Richard Andrews, EPIC Auditors Managing Director commented ‘we are extremely privileged to have somebody of Michelle’s standing and experience to present at the symposium. It offers a real opportunity for all delegates to receive the most current information on the changes facing the industry.’

This virtual pharma compliance conference will be a full day delivered remotely and is ideal for pharmaceutical industry professionals in quality control, quality assurance, supply chain and production management, as well as Qualified Persons, regulatory and compliance specialists involved in the manufacturing of medicines. 

The event will provide the latest information and guidance on changing legislation and give you insight into what you might have missed since the start of the pandemic. 

To find out more and to book your place follow the link here

We at EPiC Auditors Ltd will be running our very first virtual GMP pharma compliance conference on Tuesday 1st February 2022. The theme is Back to the Present; an opportunity to see what you’ve missed during the pandemic and what’s on the horizon.

This virtual GMP symposium 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, with a few laughs along the way.

The EPiC GMP pharma compliance conference is ideal for pharmaceutical industry professionals in quality control, quality assurance, supply chain and production management, as well as Qualified Persons, regulatory and compliance specialists involved in the manufacturing of medicines.

The day will provide you with the latest information and guidance on changing legislation and give you insight into what you might have missed since the start of the pandemic. Through presentations on current deficiency trends and an IAG case study, you will learn how to maintain a compliant PQS and better manage remote inspections.

Richard Andrews, Managing Director and Senior Consultant for EPiC says, “We are really excited to be delivering this symposium and to be sharing the collective knowledge of the ex-MHRA Inspectors working for EPiC Auditors. The regulations, guidance and expectations are continually evolving and companies need to ensure they stay up to date to remain compliant.”

Tickets cost £250.00 and include Multi-attendee discounts – book one place at the full price and book up to three further places at the same time at a 50% discount.

This event is brought to you in collaboration with SeerPharma UK

To buy tickets follow the link below.