January 2024 Newletter
Inspection Readiness Should Be a Given
There is a plethora of information at your fingertips providing insight into Pharmacovigilance Inspections, aiming to help and guide Marketing Authorisation Holders (MAHs) to be inspection ready. Ultimately, an MAH should be working on a daily basis with processes that would stand up to an inspection. The notification of an imminent inspection should not be the trigger that changes process or gets documents written. The reason for the inspection is to ensure the MAH is adhering to the law and that the product is safe and effective for the patient. And this should be consistent with daily practice.
Regulators summarise their inspection findings in yearly reports and it is good practice to review these reports to gather valuable insight into what the regulators are spending time observing and where their interests may lay so that you can proactively complete any internal remediation prior to being inspected.
The MHRA released their Pharmacovigilance Inspection Metrics report in September 2023, consolidating the findings from 32 inspections [of 30 MAHs]. Five of these inspections were triggered to assess the resolution of critical findings from previous inspections. Interestingly two of these inspections had not adequately adopted any measures for corrective action of the previous findings so new critical findings were issued. The lesson here is that the MAH must address all critical findings in a timely manner and be able to evidence such in the next inspection which will surely be scheduled sooner rather than later. The MHRA full report can be reviewed here: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1182091/MHRA_GPvP_inspection_metrics_2021-22.pdf
The FDA produces a spreadsheet of findings they find objectionable during a fiscal year. These observations are listed on an FDA Form 483 and the number of times it was cited as an objectionable finding by the FDA and it’s representatives is tallied on the spreadsheet. The historical fiscal year spreadsheet summaries can be located here: Inspection Observations | FDA
Inspections are not to be taken lightly but much can be done to make you inspection ready. Mock inspections are a great idea to get people used to answering questions precisely and practising document retrieval for instance. Much consideration prior to the inspection must be given to identifying those who will be interviewed, where the war room will be located, the IT requirements, how far the interview room is away from the nearest bathroom and the route which should be taken etc. It is worth noting that colleagues who are excellent in their day to day work/experts in their field might not be the best person to put in front of an interview panel due to nerves. A cool, steady host to keep proceedings moving in the right direction is vital, as is a scribe who can capture verbatim discussions to create a factual summary that can be referenced in real time and post-inspection.
After the inspection, the findings need to be analysed, actioned and corrective measures put into place in a timely manner. It is worth spending time reviewing the inspection process, gathering feedback from all involved to produce a lessons learnt report for future inspection preparedness.
It is worth stating that the Inspectors aren’t trying to “catch you out”. They are wanting to ensure processes undertaken are robust, consistent and documented to ultimately keep the patient safe. Which is what we all fundamentally want and it is where Truliant can help if you have any inspection readiness concerns. We have great experience in helping companies with inspection readiness and even participating in inspections. Please reach out to us if you require any help or guidance in inspection matters.
Upcoming Events from Truliant
We have kicked off Season 2 of our informative podcasts. Topics so far have included ‘Artificial Intelligence’ to ’Navigating your way through PV’. You can listen to all episodes on any of these platforms;
🍏 Apple: https://lnkd.in/epCStTmJ
🎧 Spotify: https://lnkd.in/esHKmjvT
💻 Google Podcasts: https://lnkd.in/em2_5sgf
📺 YouTube Podcasts: https://lnkd.in/esZKjJig
📣 TuneIn + Alexa: https://lnkd.in/eQEJsUch
🔊 Amazon Music: https://lnkd.in/eNWGUQmY
🌐 Podcast Index: https://lnkd.in/enPKXcNW
💾 Deezer: https://lnkd.in/epFDaMV5
🎤 Player FM: https://lnkd.in/ePcgvTFz
Our first webinar took place on Thursday 29th November discussing digital transformation and putting the patient first. This too can be viewed on either of these platforms: https://lnkd.in/eC9n_EJ3 https://lnkd.in/eAUSbdyy
Representatives from Truliant will be available to meet at the DIA PVRM meeting in Baltimore from 5-7 February 2024 and also at the Oracle Safety Innovation Summit in Reston from 8-9 February 2024. We will also be partnering with Biologit at Booth No. 234 at the SCOPE Summit in Orlando from 11-14th February. If you’d like to arrange a meeting please don’t hesitate to reach out to us on firstname.lastname@example.org or swing by the booth in Orlando to say Hi!
If you are interested in our view/insight into a topic we will endeavour to do our best to cover it in a future newsletter. Please reach out to Pam Strowgger (email@example.com) with the details.
One More Thing…………………………………
Keep your eyes open on our LinkedIn page Truliant Consulting: My Company | LinkedIn as we will be sharing some exciting news with you in early February! Watch this space!