Compliance Corner Edition 9

Introduction

Welcome to Edition 9 of GMP Compliance Corner. We had a slight change of plan last week. With school holidays and the realities of work and family life, we hit pause on video uploads. Just a reminder: Help Me GMP is something we run in our own time, and we appreciate your patience and continued support.

This week, we're back and ready to go. We’ll be dropping our long-awaited interview with PMT at the Making Pharmaceuticals and Distributing Pharma event. We promise it’ll be worth the wait.

In the meantime, this edition brings you a fresh dose of GMP updates, including sustainability in pharma, major regulatory insights, critical recalls, and more.

Coming This Week

• Interview with PMT at Making Pharmaceuticals This week, we’re bringing you a brand-new interview with PMT (Particle Measuring Technology), filmed live at the Making Pharmaceuticals Conference. We dive into airborne particle monitoring, cleanroom qualification, and how technology is evolving to meet Annex 1 requirements. Whether you're in QA, cleanroom operations, or validation, this conversation offers actionable insight from one of the leaders in contamination control. 🔗 Learn more about PMT: www.pmtgb.com

• GMP Shorts Series Continues We’re also releasing more of our popular GMP Basics Shorts on YouTube. These bite-sized training videos are perfect for quick refreshers on the go — whether you're grabbing coffee or catching a breather between batch reviews.

500 Subscriber Giveaway – Congratulations to Our Winner

We recently hit 500 subscribers on YouTube and marked the milestone with a limited-time giveaway exclusively for our community.

The draw took place on June 1st. Congratulations to our winner, and thank you to everyone who supported the channel by entering. Keep an eye out for future giveaways as we continue to grow.

You can visit the channel and explore our latest content here: https://www.youtube.com/@HelpMeGMP

Regulatory Updates

MHRA (UK) Real-World Data Consultation The MHRA has launched a six-week consultation on the use of real-world data (RWD) in clinical trials. This move aims to support regulatory decision-making, particularly for innovative treatments where randomized controlled trials (RCTs) may not be feasible. Stakeholders are encouraged to share their perspectives on how RWD can be safely and effectively integrated into the UK’s licensing framework. 🔗 Read more at GOV.UK

GMP & GDP Certificates Blog A recent MHRA Inspectorate blog clarifies that GMP and GDP certificates do not, on their own, confirm compliance. The MHRA urges stakeholders to consider full inspection reports, which provide critical context behind certification status — particularly in procurement decisions or due diligence. 🔗 Read the MHRA blog

EMA (EU) CHMP Recommends 10 New Medicines The EMA’s Committee for Medicinal Products for Human Use (CHMP) issued positive opinions on ten new medicines, ranging from treatments for rare cancers to vaccines. This reflects the agency's ongoing push to expand therapeutic options and tackle unmet medical needs across the EU. 🔗 Read more at EMA

Data and AI Work Plan (2025–2028) The EMA and Heads of Medicines Agencies (HMA) released a joint strategic work plan focusing on how artificial intelligence and real-world data can be responsibly leveraged to modernize medicines regulation. Key priorities include data interoperability, transparency, and algorithm validation. 🔗 Read more at Hogan Lovells

FDA (USA) COVID-19 Vaccine Update – 2025–26 Season The FDA’s VRBPAC advisory committee met in May to evaluate strain selection for the 2025–2026 COVID-19 season. The committee recommended targeting the LP.8.1 variant, citing increasing global prevalence and early immunogenicity data from manufacturers. Final guidance for vaccine producers is expected shortly. 🔗 Read more at NPR

FDA Approves First Alzheimer’s Blood Test In a breakthrough for diagnostics, the FDA approved a blood-based test to aid in the early detection of Alzheimer’s disease. The test measures plasma biomarkers associated with amyloid pathology, offering a less invasive and more scalable option than PET scans or spinal taps. 🔗 Read more at the FDA

News from Pharma

GSK’s Nucala Approved for COPD by FDA GSK has received FDA approval to expand the use of Nucala (mepolizumab) for adults with chronic obstructive pulmonary disease (COPD) characterised by eosinophilic inflammation. This is a major regulatory win, as Nucala becomes the first biologic approved specifically for eosinophilic COPD—a condition affecting millions and notoriously difficult to treat with conventional therapies. Clinical trials showed significant reductions in exacerbation rates and improved quality of life among high-risk patients. The approval reflects a shift toward personalised medicine in respiratory care. 🔗 Read more at Reuters

Pfizer and Moderna Strengthen EU mRNA Manufacturing In response to post-pandemic lessons, Pfizer and Moderna are investing heavily in European mRNA production infrastructure. Pfizer announced upgrades to its Puurs, Belgium facility—one of the largest vaccine production hubs in the world—while Moderna is expanding its plant in Madrid, Spain. These moves aim to decentralise vaccine manufacturing, reduce lead times, and ensure regional supply autonomy in future health emergencies. The EU has encouraged such moves under its HERA (Health Emergency Preparedness and Response Authority) strategy. 🔗 Read more at Financial Times

AstraZeneca Pilots AI for Batch Record Review AstraZeneca has launched a pilot programme that uses machine learning and natural language processing to automate batch record review across its Swedish and UK sites. The AI system can flag inconsistencies, identify patterns in deviations, and suggest corrective actions before human review. The ultimate goal is to reduce the time between production and batch release—currently one of the biggest bottlenecks in pharmaceutical manufacturing. The pilot is part of AstraZeneca’s wider digital transformation strategy, aimed at embedding AI into core GMP workflows. 🔗 Read more at Pharmaphorum

News from NHS Aseptic Units and NHS SPS

NHS Aseptic Services Review 2025 – Progress Update NHS England’s programme to transform aseptic services across Integrated Care Systems (ICSs) continues to gather momentum. The initiative aims to establish regionally coordinated hub-and-spoke aseptic models, enabling increased batch preparation of high-risk products like chemotherapy, monoclonal antibodies, and parenteral nutrition. Recent updates confirm that multiple sites, including new build and repurposed units, are entering commissioning stages, with training, governance, and digital traceability systems as core enablers. The strategy targets a tenfold capacity increase by 2026, focusing on standardisation, resilience, and reduced burden on clinical areas. 🔗 Read more at NHS England

SPS Releases New Guidance on Microbiological Monitoring The Specialist Pharmacy Service (SPS) has published updated guidance for microbiological monitoring within NHS aseptic units. The document clarifies best practices for Grade A and B environments, with a stronger emphasis on real-time response to environmental monitoring (EM) trends. It includes case examples on responding to out-of-trend results, the role of settle plates vs active air sampling, and expectations during MHRA inspections. Units are encouraged to update local SOPs to reflect these practices, especially around routine data trending and EM alert/action limits. 🔗 Access the guidance

SPS Podcast – Quality Assurance in Aseptic Services The SPS Quality Assurance podcast series continues to be a valuable training tool for NHS aseptic and QA teams. Recent episodes cover:

• Cleanroom contamination control strategies

• Preparing for MHRA inspections

• The evolving role of remote batch certification Each episode features interviews with NHS QA leaders and offers real-world lessons, making it ideal listening for those in pharmacy production, quality, or governance roles. 🔗 Listen to the QA podcast series

• Recalls in Pharma

  MHRA (UK)

  1. Teva UK – Salbutamol 2.5mg Nebules (Class 1 Recall) Teva UK has issued a Class 1 recall for its Salbutamol 2.5mg/2.5ml Nebuliser Solution due to microbial contamination detected during routine quality control. This contamination poses a significant risk of respiratory infections, particularly in vulnerable patients. Healthcare professionals are advised to stop using the affected batches immediately and return them to the supplier. 🔗 MHRA Recall Notice

  2. Galpharm – Cold & Flu Capsules (Labelling Error) A recall was issued for Galpharm Cold & Flu Relief Capsules due to incorrect blister labelling. The outer packaging listed the correct active ingredients, but the blisters themselves showed different component details, potentially misleading patients and healthcare professionals regarding the medication content. 🔗 MHRA Recall Notice

  FDA (USA)

  1. Intas Pharmaceuticals – Warning Letter and Import Alert The FDA has issued a warning letter to Intas Pharmaceuticals following an inspection of its Gujarat, India facility. The inspection revealed significant violations, including falsified stability data, inadequate cleaning procedures, and data manipulation during visual inspections. As a result, the FDA has placed the facility on import alert, allowing U.S. officials to detain products from Intas without physical examination. 🔗 FDA Warning Letter 🔗 Import Alert 66-40Wikipedia

  2. AvKare – Recall of Multiple Ophthalmic Products AvKare has voluntarily recalled over 75,000 cases of eye care products, including artificial tears and ophthalmic solutions, due to potential sterility issues identified during an FDA audit. The recall affects products distributed nationwide between May 26, 2023, and April 21, 2025. The FDA has classified this as a Class II recall, indicating that use of these products may cause temporary or medically reversible adverse health consequences. 🔗 FDA Recall Notice 🔗 CT Insider Article

  EMA (EU)

  1. Valsartan Recall – Nitrosamine Impurities Several manufacturers across Europe issued recalls of Valsartan-containing products due to the presence of nitrosamine impurities above acceptable intake limits. These substances are classified as probable human carcinogens and have been the focus of EMA safety reviews since 2018. 🔗 EMA Information on Nitrosamine Impurities

  2. Metformin Extended Release – Quality Defects Detected A batch-level recall was conducted for certain metformin extended-release tablets after stability studies revealed out-of-specification results, including inconsistent drug release rates. The EMA coordinated the recall across multiple EU countries via its Rapid Alert system. 🔗 EMA Update on Metformin Medicines

  Training & Development

  NSF – Pharmaceutical GMP Training

  NSF offers an interactive course designed to help professionals apply pharmaceutical GMP principles effectively in their workplaces. The training covers key aspects of GMP compliance, including quality management systems, documentation practices, and regulatory expectations. Participants will engage in practical exercises to reinforce learning and can earn a certificate upon completion. 🔗 NSF Pharmaceutical GMP TrainingNational Science Foundation

  ECA Academy – GMP for Beginners

  ECA Academy provides a live online training course tailored for individuals new to GMP. The program covers the fundamentals of GMP, including regulatory frameworks, quality assurance, and production processes. It's ideal for new employees or those transitioning into GMP-regulated roles. 🔗 ECA Academy GMP for BeginnersECA Academy

  ISPE – GMP Online Training Courses

  The International Society for Pharmaceutical Engineering (ISPE) offers an eleven-part online series focusing on the fundamentals of GMP. The courses provide comprehensive coverage of GMP regulations, manufacturing controls, and quality systems, suitable for professionals seeking to deepen their understanding or fulfill continuing education requirements. 🔗 ISPE

  LearnGxP – GMP 2025 Annual Refresher

  LearnGxP's annual refresher course is designed to update professionals on the latest GMP practices and regulatory changes. The course includes interactive scenarios related to cleaning, maintenance, and environmental monitoring, ensuring participants can apply GMP principles effectively in their roles. 🔗 LearnGxP

  GxP-Training – GMP Learning Path

  GxP-Training offers a comprehensive learning path consisting of six certified courses aimed at developing GMP expertise. The program covers topics such as quality management, documentation, manufacturing operations, and validation, culminating in a certification that demonstrates proficiency in GMP principles. 🔗 GxP-Training GMP Learning Path

  Upcoming Conferences

  ISPE Europe Annual Conference 2025 – London (12–14 May) The 2025 ISPE Europe Annual Conference, held in London, featured a dedicated sustainability track. Discussions centered on the challenges of implementing sustainable practices in pharmaceutical engineering, with insights from case studies and roadmaps addressing hurdles to achieving low-impact production. ISPE+2ISPE+2ISPE+2

  31st Annual Medicines for Europe Conference – Brussels (25–26 June) Scheduled for 25–26 June 2025 in Brussels, this conference will focus on building a resilient health union, emphasizing security, access, and competitiveness. Key discussions will include strengthening the European Health Union through high-level policy dialogue and advancing innovation and manufacturing via strategic EU initiatives. Medicines for Europe

  GMP in Food

  FDA Highlights Inefficiencies in Food Recall System At the 2025 Food Safety Summit, FDA officials and public health experts addressed significant flaws in the U.S. food recall system. Despite numerous FDA-issued public recall alerts annually, critical delays in classifying and communicating recalls remain prevalent. Experts emphasized the need for more effective consumer communication strategies to ensure public safety. foodpolicy.rutgers.edu+2Food & Wine+2Food Safety+2Food Safety+1Food & Wine+1

  Fun Pharma Fact of the Week

  FDA Approves First Blood Test for Alzheimer's Diagnosis The FDA has approved the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, the first blood test to aid in diagnosing Alzheimer's disease. This test offers a less invasive option, reducing reliance on PET scans, and increases diagnostic accessibility for patients aged 55 and older exhibiting symptoms of the disease. BMJ+7U.S. Food and Drug Administration+7AJMC+7Wikipedia+3People.com+3U.S. Food and Drug Administration+3

  Summary

  In this edition, we've covered:

  • Upcoming Conferences: Insights into the ISPE Europe Annual Conference and the forthcoming Medicines for Europe Conference.

  • GMP in Food: FDA's concerns over the current food recall system's effectiveness.

  • Pharma Fact: The FDA's approval of a groundbreaking blood test for Alzheimer's diagnosis.

  Stay informed and ahead in your field by keeping up with the latest developments in pharmaceutical compliance and innovation.

  Call to Action

  • Subscribe to our YouTube channel – Help Me GMP for the latest videos and updates.

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  Thank you for being a part of the GMP Compliance Corner community. Your dedication to staying informed ensures excellence in pharmaceutical practices.

  Kyle Winn