“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.   

2. 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.​ 

3. 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​. 

4. 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. 

5. 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 at enquiries@epic-auditors.com

Top Tips for Implementing Effective Knowledge Management Practices

Article By Michelle Yeomans Operations Manager for EPiC Auditors

At the EPiC Autumn Compliance Seminar, I delivered a presentation outlining the direction of travel in demonstrating compliance  (Session 1. GMP Seminar 10th November 2022 9am to 10am) which highlighted how global regulators are looking at new ways to be agile and make best use of resources and reduce regulatory complexity.  

The aim is to benefit patients by supporting access to quality medicines by adopting the same requirements for the formats and data expectations in regulatory submissions and applying the same standards in regulatory review, assessment, and inspection to support reliance. Such approaches will require companies to demonstrate effective use of data, knowledge management and to implement a culture of continuous improvement throughout the product lifecycle.

How organisations create, manage, and use knowledge is a key component of an effective Pharmaceutical Quality System (PQS) as defined by ICH Q10. The need to minimise knowledge loss is a primary concern, as loss of knowledge can lead to poor risk-based decision making and inefficiencies in trying to retrieve past knowledge or having to  “reinvent the wheel” to replace lost knowledge.

Hardly a week goes by without seeing a post on LinkedIn from a network connection who is “happy to share” that they are starting a new position. Whilst this is exciting for the individual to be embarking on a new chapter in their career, what can organisations do to minimise the risk of specialist knowledge walking out of the door with them?

Tips for implementing effective knowledge management practices:

1. It’s important to recognise that it is the people and not the data that underpin an organisations’ knowledge base. Compile and maintain a list or matrix of subject matter experts (SMEs) to increase awareness of “go to” people and encourage communication, networking and sharing of past and current knowledge.
2. Don’t wait until someone is working their notice to try to capture all that they know, as there won’t be enough time to transfer valuable knowledge to colleagues. Think about how you can capture and manage knowledge as a continuous improvement activity e.g., capturing and implementing lessons learned and after-action reviews.
3. Advances in technology to support remote collaborative working accelerated during the Covid-19 pandemic and has increased the availability and accessibility of creative tools to capture and share information. Explore what options are available with IT and Data Management colleagues to make use of available tools to help build and improve your knowledge management systems.
4. Asking someone to write down everything they know about a particular product, process, system, operation is a daunting task. People may not be aware of the knowledge they possess or how valuable it is to others. Indecision on what to include could result in a lot of the implicit knowledge remaining in people’s heads and at risk of being lost. As implicit knowledge is often difficult to articulate, transfer of knowledge can be achieved more effectively by encouraging regular interaction with colleagues e.g., networking forums, and sharing practical experiences through coaching and mentoring opportunities.  
5. For knowledge to be usable, it needs to be captured in an effective manner. Consider using a variety of formats to encourage information sharing and capturing knowledge e.g., video recordings, voice notes, whiteboards, story boards etc. Look at how the resulting output could be adopted into workflows, SOPs, Work Instructions, etc. as continuous improvement helping to retain current knowledge and support the development of new knowledge.

The above practical tips are intended to help minimise the risk of knowledge loss and support compliance with the EU GMP requirement to implement quality improvements appropriate to the current level of process and products knowledge (EU GMP Chapter 1, 1.4 (xi)) and ICH Q10 principles.

If you need our help and support, then please don’t hesitate to contact us.

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