Compliance Corner Edition 7
Introduction We’ve hit a major milestone — 500 YouTube subscribers and counting! Thank you to everyone supporting the Help Me GMP mission to make compliance clearer, friendlier, and more accessible. To celebrate, we’ve launched a subscriber competition to win a YETI mug, and we’re giving you a behind-the-scenes look at what makes a great pharmaceutical expo in our Making Pharmaceuticals special. As always, this edition is packed with actionable insight — from global recalls and NHS aseptic updates to new FDA vaccine guidance and EMA product approvals.
Introduction
We’ve hit a major milestone — 500 YouTube subscribers and counting! Thank you to everyone supporting the Help Me GMP mission to make compliance clearer, friendlier, and more accessible. To celebrate, we’ve launched a subscriber competition to win a YETI mug, and we’re giving you a behind-the-scenes look at what makes a great pharmaceutical expo in our Making Pharmaceuticals special.
As always, this edition is packed with actionable insight — from global recalls and NHS aseptic updates to new FDA vaccine guidance and EMA product approvals.
🎥 New Videos Released
500 Subscribers! Help Me GMP Giveaway A short video to celebrate reaching our first major growth milestone! We’re proud to be building something meaningful for the GMP community and we want to give back. 📺 Watch here
What Makes a Pharma Expo Great? We take you into the world of Making Pharmaceuticals 2025, sharing insights from exhibitors and attendees about why face-to-face collaboration still matters in a digital world. 📺 Watch here
GMP Basics Shorts Series Two new shorts in our GMP Basics series break down essential concepts.
ICH Guidelines Promo A promotional short revisiting our in-depth video on ICH guidelines, highlighting key takeaways for your compliance journey. 📺 Watch here
Coming This Week
How Pharma is Trying to be Green Is the pharmaceutical industry truly sustainable? Can pharma companies be both GMP-compliant and environmentally responsible? In this in-depth video, we explore the growing movement of Green Pharma — breaking down how sustainability initiatives are reshaping pharmaceutical manufacturing. From solvent recovery and energy-efficient cleanrooms to green chemistry and supply chain design, we’ll show how GMP and environmental stewardship don’t have to be at odds. Essential viewing for anyone in QA, production, or validation who wants to future-proof their operations.
📰 News from MHRA, EMA, and FDA
Regulatory Updates
MHRA – Inspection Metrics & Strategic Direction
Inspection Metrics Dashboard (May 2025): The MHRA's latest inspection metrics indicate a significant increase in critical deficiencies, particularly in documentation practices and operator training. This trend suggests a heightened regulatory focus on personnel qualifications and SOP adherence in upcoming inspections.
Strategic Direction for British Pharmacopoeia & Laboratory Services: In a recent board meeting, the MHRA discussed the future strategic direction of the British Pharmacopoeia and Laboratory Services, emphasizing the need to support the agency's broader objectives and adapt to evolving regulatory challenges. GOV.UK
🇪🇺 EMA – Paediatric Formulation Guidance
Reflection Paper on Formulations of Choice for the Paediatric Population: The EMA released a reflection paper aiming to assist in developing paediatric formulations suitable for neonates, infants, and children of all ages. The document emphasizes the importance of taste masking, age-appropriate dosing, and safety testing early in the development process to ensure medication adherence and efficacy in paediatric patients. Read Here
Guideline on Pharmaceutical Development of Medicines for Paediatric Use: This guideline provides additional direction for the pharmaceutical development of medicinal products intended for children between birth and 18 years. It underscores the necessity of ensuring consistent quality, positive benefit-risk balance, and adequate patient adherence without imposing unnecessary burdens on patients or caregivers. Read Here
🇺🇸 FDA – Upcoming VRBPAC Meeting on COVID-19 Vaccines
May 22, 2025 VRBPAC Meeting Announcement: The FDA has scheduled a Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on May 22, 2025, to discuss and make recommendations on the selection of strains to be included in COVID-19 vaccines for the upcoming immunization campaign. Read Here
Considerations for 2024-2025 COVID-19 Vaccine Formula Composition: The FDA's considerations for the 2024-2025 COVID-19 vaccine formula composition include evaluating the current epidemiology of SARS-CoV-2 variants and assessing the effectiveness of existing vaccines. The agency aims to ensure that updated vaccines provide improved protection against circulating strains. Read Here
🧪 News from Pharma
GSK Acquires RNA Platform Developer Elsie Biotechnologies
GSK has acquired San Diego-based Elsie Biotechnologies for up to $50 million to bolster its oligonucleotide therapeutics pipeline. Elsie's platform technology enables the development of RNA-based medicines that can modulate gene expression, offering potential treatments for diseases that are challenging to address with traditional small molecules or biologics. This acquisition aligns with GSK's strategy to expand its capabilities in nucleic acid therapeutics. Read Here
Pfizer and Moderna Expand mRNA Manufacturing Footprint in EU
Pfizer and Moderna have received approvals from the European Medicines Agency (EMA) to increase their mRNA vaccine manufacturing capacities within the EU. Pfizer's facility in Puurs, Belgium, has been authorized to scale up batch sizes, enhancing the supply of its COVID-19 vaccine, Comirnaty. Similarly, Moderna has been approved to add a new filling line at its Rovi facility in Spain, aiming to boost the production of its vaccine, Spikevax. These expansions are part of efforts to decentralize production and address post-pandemic capacity challenges. Read Here
AstraZeneca Launches AI-Powered Batch Review Pilot
AstraZeneca has initiated a pilot project employing artificial intelligence to enhance batch record reviews across its manufacturing sites in Sweden and the UK. The AI system is designed to pre-screen batch records for compliance trends and detect exceptions, aiming to streamline the review process and ensure data integrity. This initiative reflects AstraZeneca's broader commitment to integrating AI and data science into its R&D and manufacturing operations. Read Here
🏥 News from NHS Aseptic
SPS QA Podcast: Batch Certification Best Practice A new QA episode highlights how remote certification, digital records, and deviation assessment are being approached across NHS aseptic units. 🔗 Listen here
Recalls
Teva UK Recalls Salbutamol 2.5mg Nebules – Contamination Risk (Class 1)
Teva UK has initiated an urgent Class 1 recall of specific batches of Salbutamol 2.5mg Nebules due to the detection of microbial contamination during routine quality control testing. This contamination poses a significant risk of respiratory infections, particularly in vulnerable populations such as pediatric, elderly, and immunocompromised patients. Healthcare professionals are advised to quarantine affected stock immediately and notify patients who may have received the impacted batches.
FDA Issues Warning Letter to Intas Pharmaceuticals (India) for CGMP Violations
On November 21, 2023, the U.S. Food and Drug Administration (FDA) issued a warning letter to Intas Pharmaceuticals Limited following an inspection of their manufacturing facility in Ahmedabad, India. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations, including:
Data Integrity Issues: Visual inspectors were found to have manipulated defect counts on manual visual inspection records to keep rejection rates within acceptable limits.
Inadequate Quality Oversight: The Quality Assurance (QA) department failed to exercise proper oversight, allowing the continuation of these practices without adequate review or intervention.
The FDA has deemed the firm's response inadequate, citing a lack of comprehensive corrective actions and preventive measures to address the identified deficiencies. The agency has requested a detailed remediation plan, including assessments of documentation systems and management Read Here
🎓 Training Providers
NSF: Annex 1 Implementation Training (Online, June 3) A 1-day virtual course exploring risk-based strategies for sterile manufacturing teams. CPD certified. 🔗 Register
QP Quandary: Cleanroom QA Scenarios – New Edition Released The latest GMP dilemma focuses on real-time particulate monitoring and operator interventions during aseptic media fills. 🔗 Visit site
📅 Upcoming Conferences
Cleanroom Technology Conference – May 21, Birmingham Focused on contamination control, environmental monitoring, and PIC/S Annex 1 case studies.
PDA Europe: ATMPs & Advanced Therapies – June 2025, Berlin Featuring deep dives on GMP for gene therapies and decentralised production. 🔗 Conference page
🥫 GMP in Food
FDA Finalises Guidance on Dietary Supplement GMPs The update to 21 CFR Part 111 tightens requirements for batch records, raw material supplier approval, and lab method verification. Emphasis on allergen controls and consumer complaint tracking has increased.
🎉 Fun Pharma Fact of the Week
The very first GMP regulations were published by the FDA in 1963 — over 60 years ago! And they were inspired by... contaminated cranberry sauce (yes, really).
📝 Summary
From cleanroom interviews and recalls to major milestones and regulatory updates — this is our biggest edition yet. Bookmark it, share it, and start your week smarter.
📣 Call to Action
🎯 Subscribe to the LinkedIn newsletter 📺 Join 500+ YouTube subscribers: youtube.com/@HelpMeGMP 🏆 Enter our 500-subscriber giveaway — details on the channel!
See you new week