Compliance Corner Edition 10

Introduction

Welcome to Edition #10 of GMP Compliance Corner.

We can’t believe we’ve already reached our 10th edition! What started as a simple weekly update is now reaching GMP professionals across the UK, Europe, and beyond. Whether you’re one of our early subscribers or just joined us, thank you for reading, subscribing, and sharing. Your support helps us keep this content free, focused, and community-driven.

In this issue, we’re covering the latest developments from regulators like the MHRA, EMA, and FDA, product recalls you need to know about, new training opportunities, and some exciting industry events on the horizon. Whether you work in QA, QC, Production, Regulatory Affairs, or Training, we’ve got something for you in this week’s roundup.

New Videos Released

What is a Qualified Person (QP)? In this week's main video, our resident QP Adam takes the mic to explain what a QP really does from certifying batches and reviewing compliance data to serving as the final sign-off before release. Whether you’re new to pharma or looking to deepen your understanding of the QP’s critical role under EU GMP, this video is a must-watch. 🔗 Watch the full video

Also Released: Interview with PMT at Making Pharmaceuticals 2025 As part of our coverage from the Making Pharmaceuticals and Distributing Pharmaceuticals event, we sat down with PMT to discuss advances in viable particle monitoring, cleanroom sensors, and real-time EM integration. A fascinating look into the future of aseptic data capture. 🔗 Watch the interview

Regulatory Updates

MHRA (UK)

• MHRA Opens Real-World Data Consultation The MHRA is seeking industry feedback on the use of real-world data (RWD) in clinical trials. This six-week consultation explores how data from routine healthcare such as electronic patient records and observational studies could support regulatory decision-making, especially when randomised controlled trials aren’t feasible. The MHRA is particularly interested in how RWD could speed up drug access in oncology, rare diseases, and other high-need areas. Gov.uk – Read the consultation

• GMP & GDP Certificates Do Not Equal Compliance A new blog post from the MHRA’s Inspectorate reminds stakeholders that GMP and GDP certificates only confirm that an inspection occurred they do not imply full compliance. The actual inspection reports (which may contain critical findings) are the true reflection of a site’s status. The MHRA is urging regulators and marketing authorisation holders to avoid relying solely on certificates during supplier qualification and due diligence. Read the MHRA blog post

EMA (EU)

• Ten New Medicines Recommended for Approval At the April CHMP meeting, the EMA recommended 10 medicines for marketing authorisation, including new therapies for cardiovascular disease, oncology, and rare conditions. Highlights include:

• Data and AI Work Plan 2025–2028 The EMA and Heads of Medicines Agencies (HMA) have published a joint strategy focused on improving regulatory decisions through data science. The plan includes building common data platforms, enhancing pharmacovigilance with machine learning, and supporting AI-driven signal detection. The workplan aims to make regulatory oversight more proactive and patient-focused. Full PDF work plan – EMA

FDA (USA)

• COVID-19 Vaccine Recommendations Updated Following the May 22 VRBPAC meeting, the FDA recommended updating COVID-19 vaccine strains to target the LP.8.1 variant, which is now dominant in many regions. Manufacturers such as Pfizer and Moderna are already adjusting formulations. The committee also emphasised the importance of clear public communication to address vaccine fatigue and improve uptake for the 2025–2026 respiratory season. FDA Meeting Summary

• FDA Approves First Alzheimer’s Blood Test The FDA has approved the first laboratory-based blood test to aid in diagnosing Alzheimer’s disease. Unlike traditional PET scans or spinal taps, this test detects elevated phosphorylated tau (p-tau217) in blood samples — a biomarker linked to amyloid plaque build-up in the brain. Experts say it could revolutionise early detection, especially in primary care settings where invasive testing is not practical. FDA Newsroom

News from Pharma

GSK’s Nucala Approved for COPD in the U.S. GSK’s monoclonal antibody Nucala (mepolizumab) has received FDA approval as an add-on treatment for eosinophilic COPD. This marks the first biologic specifically approved for this COPD subtype, offering new options for patients who often experience frequent exacerbations and poor responses to standard inhalers. Read more: https://www.reuters.com/business/healthcare-pharmaceuticals/gsk-wins-us-approval-nucala-drug-treat-copd-2025-05-22/ Press release: https://www.gsk.com/en-gb/media/press-releases/nucala-mepolizumab-approved-by-us-fda/

AstraZeneca Expands AI Batch Record Review Pilot AstraZeneca is expanding its pilot of AI-powered batch record review to UK and Swedish manufacturing sites. The technology identifies data gaps, flags noncompliance, and supports faster QA turnaround times. If successful, it could redefine the role of human verification in quality review workflows. Read more: https://www.pharmtech.com/view/astrazeneca-trials-ai-in-batch-review-process

Pfizer and Moderna Boost mRNA Capabilities in Europe Pfizer and Moderna have gained EMA approval to establish or expand mRNA production sites in Germany and France, respectively. These moves are part of a long-term strategy to decentralize vaccine manufacturing and enhance Europe’s pandemic readiness. Read more: https://www.fiercepharma.com/manufacturing/pfizer-moderna-expand-european-mrna-capacity

Eli Lilly Invests $5.3 Billion in U.S. Manufacturing Eli Lilly is investing $5.3 billion in its Lebanon, Indiana site to expand production of GLP-1-based medications like Zepbound and Mounjaro. The site will feature advanced digital infrastructure, employ over 200 staff, and reinforce domestic drug resilience under the CHIPS and Science Act. Read more: https://www.cnbc.com/2025/06/02/eli-lilly-expands-glp1-production-facility.htmlCNBC

MHRA (UK)

1. Midazolam 1 mg/mL Injection – Packaging Error (Class 2) Martindale Pharma has recalled batch 20214657 after ampoules were incorrectly labelled as 10 mg/mL instead of 1 mg/mL, risking serious overdose. Read more: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-martindale-pharma-midazolam-1mg-ml-solution-for-injection-pl-00156-0099

2. Paracetamol Oral Suspension – Microbial Contamination (Class 1) A Class 1 recall was issued for unbranded paracetamol oral suspension (120 mg/5 mL) after QC found microbial contamination. The affected batches may pose infection risks to paediatric patients. Read more: https://www.gov.uk/drug-device-alerts/class-1-medicines-recall-unbranded-paracetamol-oral-suspension

FDA (USA)

1. Intas Pharmaceuticals – cGMP Violations and Import Alert FDA inspectors found falsified stability data, inadequate cleaning validation, and data discrepancies at Intas’ Gujarat site. As a result, several injectable products are subject to recall and the facility is on import alert. Read more: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/intas-pharmaceuticals-limited-662868-11212023

2. AvKare Ophthalmic Solutions – Contamination Risk AvKare recalled 35 lots of artificial tears and eye drops following discovery of microbial contamination. The FDA classified this as a Class II recall due to potential eye infection risks. Read more: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/avkare-issues-voluntary-nationwide-recall-specific-lots-eye-care-products-due-potential-nonsterility

EMA / EU Market

1. Irbesartan Recall – Nitrosamine Impurity Multiple EU countries recalled irbesartan batches after lab tests showed nitrosamine impurities above internationally accepted limits. These compounds are probable human carcinogens. Read more: https://www.ema.europa.eu/en/news/irbesartan-batches-recalled-due-impurity-concern

2. Clopidogrel 75 mg Tablets – Dissolution Defect The EMA coordinated a recall of clopidogrel tablets across EU member states due to stability failures and issues with drug release in batch dissolution testing. Read more: https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/quality-defects

Training & Learning

NSF: EU GMP Annex 1 Update Masterclass NSF is offering a deep dive into the revised Annex 1 for sterile manufacturing. The course covers contamination control strategies, environmental monitoring limits, and PUPSIT (Pre-Use Post-Sterilisation Integrity Testing). Suitable for QA, validation, and sterile production teams. Read more: https://www.nsf.org/training/pharma-biotech/eu-gmp-annex-1-update-masterclass

QP Quandary Mock Viva Series Designed for trainee QPs or advanced learners, this online series walks you through regulatory dilemmas and grey areas you might encounter during a real QP viva. Each session includes expert feedback and MHRA-style questioning. Read more: https://www.qpquandary.com/mock-viva-course

LinkedIn Learning: Pharmaceutical Quality Systems This self-paced course introduces QMS principles aligned to GMP and ICH Q10, covering CAPA, change control, risk assessment, and audit readiness. Ideal for new QA staff or continuing professional development. Read more: https://www.linkedin.com/learning/pharmaceutical-quality-systems

Upcoming Conferences

ISPE Europe Annual Conference – London, June 2025 This year’s ISPE Europe conference features expert panels on sustainability, digitalisation, Annex 1 implementation, and contamination control. One standout session will explore the role of AI in batch review and release. Read more: https://ispe.org/conferences/2025-europe-annual-conference

31st Annual Medicines for Europe Conference – Brussels, June 25–26, 2025 Focused on securing the EU’s medicines supply chain, this conference will include sessions on regulatory harmonisation, pricing reform, and post-COVID-19 pharmaceutical strategy. Read more: https://www.medicinesforeurope.com/events/31st-annual-conference-2025

GMP in Food

FDA Warning on Ineffective Food Recalls The FDA has published a report highlighting critical failures in how food recalls are communicated to the public. Findings show that recall notices often fail to reach consumers in time, with gaps in retailer response, traceability, and public visibility. Read more: https://www.fda.gov/news-events/press-announcements/fda-report-reveals-gaps-food-recall-communication

Eurofins GMP Certification for Supplements Eurofins has launched a new certification scheme tailored to EU food supplement manufacturers. The program includes audit coverage of supplier qualification, hygiene monitoring, and allergen control, aligning closely with 21 CFR Part 117 standards. Read more: https://www.food-safety.com/articles/10061-new-gmp-certification-program-for-food-supplements-seeking-us-regulatory-compliance

Fun Pharma Fact of the Week

The First GMP Law Was Passed in 1963 Did you know? The original GMP regulations were signed into U.S. law in 1963, following a wave of public concern over drug safety. Today, GMP principles are enforced in over 100 countries — a global standard born from a local crisis.

Summary & Call to Action

That’s a wrap for our 10th edition! This week we covered the latest regulatory news, product recalls, cleanroom innovation, and even the roots of GMP itself. A huge thank you to everyone who’s joined us on this journey we’ve reached Edition 10 faster than we imagined, and we’re just getting started.

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Thanks again for reading — and here’s to another week of staying compliant, confident, and ahead of the curve.

Kyle Winn