Michelle Riddalls OBE

Able Laboratories Fraud Case: What Have We Learnt? This month’s Questions of Quality column in #LCGC reviews the (Un)Able Laboratories fraud case. It was 20 years ago when the industrial scale fraud was discovered at Able Laboratories. At the centre of the fraud was a chromatography data system (CDS) where failing results were manipulated into meeting specification. One dissolution result was originally 30.9% and manipulated to 102.8%: PASS!. The company was worth over $100 million at the start of the inspection but following the recall of over 3000 batches was bankrupt a few months later. The case is important as it is the first time there was a citation for failure to review audit trail entries under 21 CFR 211.194(a)(8). The phrase reviewed for accuracy, completeness, and compliance with established standards was interpreted to include audit trail entries and all associated electronic data. This column covers: Rock around the regulatory clock: overview of the 12 483 observations with a focus on the chromatographic observations Able’s response to the 483 was unique Long arm of the law: Criminal cases and consequences. Do you want your own pages in the Federal Register? Get debarred by the FDA! Impact on the FDA: Update of Compliance Policy Guide 7346.832 on Pre-Approval Inspection in 2010, 2019 and 2022. Data Integrity and CDS: the Good, the Bad and the Ugly 2005 – 2025. Covering regulatory guidance documents and data falsification. For the latter ,the saying never assume malice when stupidity will suffice is tested to the limit. Where are we now? Citations from two recent warning letters issued in 2025 Summary: What have we learnt since Able in 2005?   Given the reams of published regulatory guidance, industry guidance documents, and published articles, you would think that there would be good chromatography compliance and fewer regulatory citations. In many companies, particularly the larger ones, this is the case. Compliance gaps have been closed and QA are on top of the situation with management support. All that has changed in unethical companies is that falsification has morphed from the obvious into the subtle. These make it worse for all others. I would like to thank, in alphabetical order, #MonikaAndraos, #BrianAlliston, #ChrisBurgess, #MahboubehLotfinia, and #PaulSmith for their helpful input and review comments during the preparation of this column. https://lnkd.in/ebGSDN9B

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While the UK has embraced plain English in legal writing, we still cling to archaic “WHEREAS” and “FOR THAT” as if complexity equals authority. It’s time we recognized that clarity strengthens law, it doesn’t weaken it. Legal documents are meant for citizens as much as for courts — if people can’t understand their own rights and obligations without a lawyer translating, the system is failing them. Change is overdue: simple, precise language can make justice more transparent, accessible, and efficient in India. Ministry of Law and Justice Arjun Ram Meghwal

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#ICHQ9 isn’t new—and even the revision isn’t that new anymore. But the conversations it sparks are more relevant than ever. Yesterday’s session, brilliantly led by Alice Redmond was a great reminder of how essential quality risk management (#QRM) is—not just as a regulatory expectation, but as a #mindset to improve decision-making and ultimately, quality of life. Key takeaways from the discussion: • #Subjectivity is inevitable—risk perception is shaped by our experiences and biases. Acknowledging the human element is the first step toward improvement. • #Formality should match the risk. Not everything needs the same level of rigor. Let’s align our QRM approach with the actual level of #uncertainty, #complexity, and #criticality. • #Training and facilitation matter. Even regulators are still training on the updated ICH Q9(R1). Structured processes and experienced facilitators can elevate outcomes. • Let’s move beyond FMEA. There’s a world of risk tools available—choose the one that fits the situation best. Thank you to everyone who joined, and to Alice for fostering such an open, engaging discussion in the true spirit of ISPE knowledge sharing for improving lives. #ICHQ9 #QRM #ISPE #PharmaQuality #RiskManagement #ContinuousImprovement

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The MHRA’s new International Recognition Procedure (IRP) is transforming the UK regulatory landscape, offering sponsors a streamlined path to approval by leveraging decisions from trusted global regulators. With potential to accelerate timelines, reduce costs and strategically re-sequence global submissions, the IRP creates new opportunities to rethink your approach to UK market entry. Our recent Regulatory Navigator blog explores how sponsors can unlock the full potential of the IRP, from faster authorization routes to optimized submission strategies that align with broader commercial goals. Explore the insights and learn how to stay ahead in an evolving regulatory environment: https://lnkd.in/efT2369M #Regulatory #UK #MHRA #InternationalRecognitionProcedure

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📢 Big Kudos to Daniel Hill and the Clinical Investigation team at the Medicines and Healthcare products Regulatory Agency. 📢 The MHRA have published v 11.1 of the guidance for manufacturers on clinical investigations. See link here: https://lnkd.in/gZxFGtwM ✅ Wow, what a super quick turnaround, very impressed. During the session on Clinical Investigations at TOPRA - The Organisation for Professionals in Regulatory Affairs symposium, we had an open and honest discussion and myself and some other audience highlighted some principals that weren't clear from the guidance. I was looking recently to see if I could use the GSPRs instead of the Essential requirements checklist and could not find any clarification and we can't make assumptions. Both Daniel and Mark Grumbridge CSci MTOPRA were super helpful and said that this would be updated but wow, less than a week, fair play. ✅ The guidance has been updated to confirm and clarify the below: ⭕ Clinical investigations being conducted in Great Britain need to meet the requirements of the UK MDR 2002. ⭕ Where a clinical investigation includes sites in both Great Britain and Northern Ireland, submission to the MHRA must be made in line with the requirements of the EU MDR. By meeting the EU MDR, requirements of the UK MDR 2002 for clinical investigations are deemed to be satisfied. ⭕ A single application made to MHRA under the EU MDR will cover any sites proposed in both Great Britain and Northern Ireland for the same clinical investigation. ⭕ Where a clinical investigation is being conducted in Great Britain only (no sites in Northern Ireland), the submission may demonstrate meeting the EU MDR instead of UK MDR if this is the applicant’s preference. This is acceptable as the principle from the previous paragraph (regarding UK MDR requirements being deemed satisfied) continues to apply. ⭕ A link within this document for where to find MHRA's flow charts for Clinical Investigations in Great Britain and Northern Ireland. #MHRA #ClinicalInvestigations #guidance #manufacturers #sponsors #UKMDR #EUMDR #GB #NI

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For anyone interested, I've done a review of the proposed changes to EU Annex 11. I can't say I love them. The audit trail and e-signature language appear to be at odds with contemporary #GAMP and FDA thinking; their inclusion in the final regulation could potentially burden legacy GxP applications with significant technical debt. I hope this is useful to some of you. Feel free to comment below with your thoughts on the new Annex. #annex11 #computervalidation #CSV #DigitalValidation

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The MHRA have issued a blog outlining their recent approach to requests for an extension to GMP certificates. My experience at 3 companies that have already completed this desk based compliance assessment is that the form is quite extensive to fill in, covers a lot of information on your PQS, changes, deviations, issues, recalls since last inspection, How you are monitoring your own PQS performance - QMR, PQRs, and how you have dealt with issues. After submission of the assessment to the MHRA we received our updated GMP certificate in less than a week, extended for 3 years. A great response time from the MHRA. https://lnkd.in/enkNNKzF

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𝗧𝗵𝗲 𝗦𝗵𝗶𝗳𝘁 𝗙𝗿𝗼𝗺 𝗦𝗢𝗣𝘀 𝘁𝗼 𝗦𝘆𝘀𝘁𝗲𝗺𝘀 𝗧𝗵𝗮𝘁 𝗪𝗼𝗿𝗸 💬 Now many of you know I am very passionate about plain language documents and making sure your QMS procedures match what you do in practice. But... I once reviewed an SOP that was technically flawless—but nobody followed it. Why? Well this comes back to the fundamental requirement to know your audience. But in this case, also the quality culture... Because in this SOP, personnel were expected to escalate issues. But the culture didn’t support escalation or feedback. It wasn't a psychologically safe working environment. Everyone knew the issues. But even though the SOP said to speak up, nobody wanted to stick their head over the parapet. QMM has taught me that systems must reflect real behaviour, not just regulatory expectations. Quality is not just about documents—it’s about mindset, ownership, and feedback loops. 🔹 Quick Win For You Today: Ask one person on your team: “Is there a procedure you find confusing or hard to follow?” Check our my book on 'Eliminating the Gobbledygook' if you SOPs are causing issues: https://lnkd.in/gkcyGPRS #LeadershipInPharma #QMM #QualityCulture #SpeakUpForQuality

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Haven't they picked those up yet? When disposing of old computers and IT equipment (ITAD), everyone rightly focuses on data destruction, traceability and environmental compliance but there is one element that is often overlooked. How do we actually move these assets safely and efficiently from point A to point B? Whilst this may seem fairly trivial compared to the other concerns, the logistics side of things can still create risks if not managed correctly. ❌ Devices get left unsecured while waiting for collection ❌ Collections are missed or delayed due to lack of coordination ❌ There’s no clear chain of custody during transport ❌ Multiple sites follow different ad-hoc processes Aside from the data risks, poorly managed collections can be a massive pain for the team and create a lot of stress. Logistics might not be glamorous but it often provides the foundations everything else sits on.

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If you are feeling out of depth in your Regulatory role, please go and read these three short articles I have written just for you!! * How to make decisions when guidance isn’t clear https://lnkd.in/ePDKG5HF * It’s OK not to know everything in Regulatory https://lnkd.in/eDB6gy_V * Are you too risk averse to thrive in your role? https://lnkd.in/eaJdWpbu

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PMCPA is killing UK Pharma: discuss! (This is a personal post unconnected with Compliance Hub) I am a long-standing supporter of the ABPI Code. We need its boundaries and guardrails. But its viability is being undermined by a series of regulatory decisions by the PMCPA. And our industry leadership is asleep - or blind to the consequences. If I ran a European or global pharma company I would NOT base it in the UK. Or, if I did, I would not submit to PMCPA jurisdiction. Why? Because the combined effect of recent PMCPA decisions places the UK at a significant disadvantage compared to every other European country. We know the UK code is strict - and we can manage the implications of that because everyone faces the same issues within the UK. But now PMCPA is extending the reach of the UK Code overseas - which places UK businesses at a significant disadvantage compared to foreign-based businesses. Every statement below is based on interpretation of recent guidelines and code case rulings: 1. UK-based regional and global offices must certify all exhibition stands and all promotional material used at international meetings in Europe to UK standards (just in case they are seen by visiting UK HCPs) 2. Certification includes UK mandatory information including price and the UK AE reporting statement 3. When there is a conflict between the host nation and the ABPI code, the strictest wins, meaning that the UK product licence must be applied - so it is impossible to promote a product at an international meeting elsewhere in Europe with a licence that is different to the UK licence - even if it would be legally acceptable in the host country - because it is impossible to Certify in line with the UK Code 4. It is impossible to run a scientific symposium to discuss phase III data anywhere in Europe after any country in the world has submitted a licence application 5. It is impossible to run a scientific symposium to discuss the phase III data for a second indication where the dose is the same as an existing licensed dose - because the drug is no longer “in development” according to PMCPA 6. It is impossible to comply with medical education rules at international conferences held in many European countries because the UK requires control of speaker slides and Europe bans such control (but the strictest code wins according to PMCPA) If I base my European head office in Ireland I don’t get any of the above restrictions (and I also pay lower rates of corporation tax). The above rules do not apply to Spanish, German, Italian, French, Swedish or Dutch -based regional or global head offices. Just the UK. And it’s not UK law (MHRA Blue Guide) that it is dictating this scenario - these are arbitrary restrictions being imposed by the PMCPA. And because PMCPA is now fully independent from ABPI our own industry champion is powerless to do anything. Or is asleep. Prove me wrong. Please.

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