“Keep Calm and Be Prepared” – 5 Top Tips for Inspection Readiness

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.  

2. 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.  

3. 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. 

4. 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.    

5. 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/

EPiC can now reveal our full agenda for our Virtual GMDP Compliance Symposium,  Beyond the Basics: Mastering GMDP Compliance and Inspection Readiness, taking place on Tuesday 5th December 2023.

Agenda Overview:

• Recent Updates to Guidance & Regulations
• How do you know you are Inspection Ready?
• Deficiency Data-Interpretation & Root Cause Analysis
• Innovation and ATMP Panel Discussion
• Annex 1 – Contamination Control Strategy (CCS) / Gap Assessments – Workshop
• ICH Q9 (new revision) – Risk Assessment
• GDP Masterclass – challenges faced by RPis, The Windsor Framework update, GDP inspection approaches
• Q&A Panel Session

Download the full agenda here:

Please take note that our schedules are subject to changes, depending on the situation at the discretion of the organisers.

🔍Meet the Experts🔎

Our carefully selected speakers bring a wealth of industry knowledge, having served as MHRA Inspectors. Their expertise and insights will provide you with invaluable guidance in navigating the complex landscape of regulatory compliance.

Discover how our expertise can take you beyond the ‘basics’ and propel your organisation towards excellence in pharmaceutical manufacturing and compliance!

Click here to read more about our speakers!

Not available on the day? We understand your schedule may not allow you to attend all the sessions of the event. A recording of the event will remain open 24/7 for 30 days. You can access the presentations whenever it’s convenient for you during this time.

Have a question? Need to register multiple people or pay offline?

Please email enquiries@epic-auditors.co.uk

We hope to see you there!

Measuring Success – Top Tips for Assessing the Effectiveness of Training

Article By Michelle Yeomans, Operations Manager for EPiC Auditors

The Covid-19 pandemic led to changes in the amount and delivery method used by Pharmaceutical companies to conduct training. Some companies cut back on training to conserve resources for core functions, whilst others invested in virtual training and e-learning to provide continued development opportunities for their employees. The situation was no different for regulators.

During the pandemic, I was the Unit Manager of the GMP and GDP Inspectorate at the MHRA, and as well as developing remote inspection approaches to ensure a continued level of regulatory oversight, MHRA used the opportunity to dedicate Inspectorate resource to enhance the range of training materials available within the ‘Inspector Academy’ knowledge hub and developed virtual training modules and competency frameworks. At the time, it was a case of adapting to the situation and being innovative in exploring available tools and techniques to identify the “least worst” available option.

Post pandemic, several conferences and training events have now returned to being run as face-to-face events, while others are continuing to offer virtual or hybrid options to maximise accessibility and minimise costs. EU GMP Chapter 2, 2.11 refers to the need for “continuing training” to be given and for its “practical effectiveness” to be periodically assessed. Continuing training is an ongoing process of learning and acquiring new skills and knowledge to help individuals stay updated with the latest developments and changes relevant to their role and industry sector. Continuing training can include self-learning so is not just limited to attending workshops, seminars, conferences, or specialist courses. The key point is finding a way to stay current with industry trends, which will help increase expertise and proficiency and support compliance with GMP requirements. Another key consideration is the need to keep a record to document the training, as training records are routinely reviewed during a regulatory inspection and provide evidence of continuing professional development.

With different training opportunities and formats on offer, it is important to have clearly defined learning objectives and ways of collecting information to determine whether the training provided has produced the desired effect and contributed to the development of the trainee.

Here are our top tips for assessing the practical effectiveness of training:

1. Pre and post-assessments: Conducting assessments, questionnaires, or quizzes before and after the training can help measure the knowledge, skills, or behaviour changes that have occurred as a result of the training. Comparing the scores or performance levels before and after the training provides an indication of the impact of the training.
2. Observations and simulations: Observing participants during or after the training session can help assess their application of the newly acquired knowledge and skills. This can be done through simulations or real-world scenarios to evaluate their ability to transfer the learning into practical situations.
3. Follow-up assessments: Conducting assessments weeks or months after the training has taken place can help evaluate the long-term impact and effectiveness of the training. This can provide insights into whether the learning has been retained, and if it has influenced the individual’s work performance over time.
4. Feedback: Soliciting feedback from trainees and supervisors or managers who work closely with the individuals can provide an additional perspective on the effectiveness of the training. They can assess whether the training has positively impacted the individuals’ job performance, productivity, or overall contribution to the organisation.
5. Performance metrics: Comparing PQS performance, KPIs or Quality metrics before and after the training can yield insights into any improvements or changes in the workplace performance of individuals or teams who participated in the training. An overview of GMP related training completed, and a review of PQS performance to identify compliance improvement topics for inclusion in further GMP refresher training should be included as agenda items at periodic Management Review meetings.

By using a combination of these assessment methods, organisations can gain a comprehensive understanding of the effectiveness of their training efforts and identify areas for improvement.

Please get in touch if you want to know more about our virtual symposia and bespoke in-house training courses.

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

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

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

 “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