Following on from the how to prepare for a regulatory inspection advice we shared during our recent virtual symposium, one of EPiC’s GMP consultants has recently returned from helping a client in California with their inspection readiness activities in preparation for the site’s first EU GMP regulatory inspection.

The on-site consultancy support provided the opportunity for the inspection hosts and subject matter experts (SMEs) to gain an appreciation of the EU GMP inspection process style and what to expect. It highlighted general points for all staff as well as some specific Do’s and Don’ts.

Newfound Confidence

The visit provided recommendations for the management of the inspection with respect to hosting, tour, and the ‘back room’ logistics and provided the opportunity to practice the inspection document request system. The facility tour focused on identifying key GMP issues so that the consultant could work with the SMEs to develop recommendations to address any issues and provided an opportunity for the SMEs to practice presenting information to an inspector.

The client reported that our consultant had been “an amazing asset by highlighting some gaps, conveyed the likely criticality of those gaps, and provided recommendations on how to address.” The inspection readiness support has given the site a newfound confidence to approach the inspection with a realistic yet positive mindset.

The client reported that “whilst we know we will have some observations, we now feel confident that the site will show well and will be able to demonstrate that we are in a state of control”, which all bodes well for a successful inspection outcome.

Are you Inspection Ready?

Take a look at our recent top-tip article by Michelle Yeomans focusing on Inspection Readiness to help you stay calm and be prepared!

Get in touch if you want to know more about our mock inspections or bespoke inspection readiness training by using our contact form here: Contact Us

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

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

Continuing Professional Development (CPD) is becoming increasingly important for professionals in all industry sectors, regardless of their career level, job role, or responsibilities. Employers and professional bodies are placing more emphasis on the continuous learning and development of their employees and members.

EPiC Auditors has become a member of the CPD Certification Service which is recognised as the world’s leading and largest CPD accreditation service with over 25 years of experience. An application is in progress to accredit EPiC’s Virtual GMDP Symposium on 5th December 2023  to enable us to award CPD points to attendees of the event.

By being an accredited training provider, EPIC Auditors adds value to the learning experience of their symposium delegates by providing a quality framework that aligns their courses the event content with CPD standards and provides a recognised, independent verification of the learning outcomes and the CPD points awarded.

To find out more about CPD and our membership visit The CPD Certification Service (cpduk.co.uk)

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!

Unleashing Excellence in GMDP Compliance and Inspection Readiness

EPiC’s Virtual Symposium – Tuesday 5th December 2023, 9:00 am to 5:00 pm (GMT)

EPiC is excited to announce their upcoming Virtual Compliance Symposium 2023, scheduled for Tuesday, December 5th. The symposium, with the theme “Beyond The Basics: Mastering GMDP Compliance & Inspection Readiness,” will feature a lineup of esteemed former MHRA Inspector speakers who will delve into the latest updates, guidance, and regulations shaping the pharmaceutical industry.

Don’t miss this opportunity to gain valuable insights and network with industry professionals at the EPiC Auditors Ltd Virtual Compliance Symposium 2023. Register now and take an important step towards shaping a compliant future in the pharmaceutical industry.

Registration and Pricing

To register for the EPiC Virtual Compliance Symposium 2023 and book your place, please register below 👇

Tickets cost £300 + VAT.

Have a question? Need to register multiple people or pay offline? Please email enquiries@epic-auditors.co.uk

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.