Compliance Corner Edition 8
Welcome to Edition #8 of GMP Compliance Corner. This week, we delve into the pharmaceutical industry's strides towards sustainability, recent regulatory updates, significant recalls, and upcoming events. Stay informed and ahead in your field.
New Videos Released
How Pharma is Trying to be Green: An insightful exploration into the pharmaceutical industry's efforts to integrate sustainability within GMP frameworks. Discover initiatives like solvent recovery, energy-efficient cleanrooms, and green chemistry.
GMP Basics Shorts: Two concise videos focusing on fundamental GMP principles, ideal for quick refreshers.
ICH Guidelines Promo: A promotional short revisiting the importance and application of ICH guidelines in pharmaceutical practices.
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.
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Regulatory Updates
MHRA
Real-World Data Consultation on External Control Arms On International Clinical Trials Day, the MHRA launched a six-week consultation focused on using real-world data (RWD) as external control arms in clinical trials. This initiative aims to accelerate treatment approvals when randomized controlled trials may not be feasible.
• Draft guideline: https://www.gov.uk/government/consultations/mhra-draft-guideline-on-the-use-of-external-control-arms-based-on-real-world-data-to-support-regulatory-decisions News announcement: https://www.gov.uk/government/news/mhra-highlights-remarkable-progress-and-launches-real-world-data-consultation-on-international-clinical-trials-day
GMP & GDP Certificates Clarification The MHRA Inspectorate issued a blog clarifying that GMP and GDP certificates do not, on their own, confirm compliance. Stakeholders are reminded that full inspection reports provide essential context. Read the full post: https://mhrainspectorate.blog.gov.uk/2025/05/16/gmp-gdp-certificates/
EMA
Ten New Medicines Recommended for Approval The CHMP recommended ten new medicines and four indication extensions during their May 19–22, 2025 meeting. This continues the EMA’s effort to diversify treatment options for patients across Europe. Meeting summary: https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-19-22-may-2025
Data and AI Work Plan 2025–2028 The EMA and Heads of Medicines Agencies (HMA) unveiled a joint work plan to unlock the power of regulatory and health data, supporting smarter regulation and faster access to innovative therapies. Work plan highlights: https://www.ema.europa.eu/en/news/leveraging-power-data-public-animal-health
FDA
Updated COVID-19 Vaccine Guidance (May 2025) The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommends vaccines be updated to target the LP.8.1 strain of the JN.1 lineage — the dominant variant in the US — for the 2025–2026 season. Full article: https://www.reuters.com/business/healthcare-pharmaceuticals/covid-shots-should-target-newer-strains-jn1-variant-2025-26-campaign-us-fda-2025-05-22/
First FDA-Approved Blood Test for Alzheimer’s Diagnosis The FDA has cleared Lumipulse, the first blood test to assist in diagnosing Alzheimer’s disease by measuring amyloid-related biomarkers. It offers a less invasive alternative to spinal taps and brain imaging. FDA press release: https://www.fda.gov/news-events/press-announcements/fda-clears-first-blood-test-used-diagnosing-alzheimers-disease
News from Pharma
GSK's Nucala Receives FDA Approval for COPD Treatment
The U.S. Food and Drug Administration (FDA) has approved GSK's asthma drug, Nucala (mepolizumab), as an add-on maintenance treatment for adults with chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype. This approval is based on positive results from the MATINEE and METREX phase III trials, which demonstrated a significant reduction in the annual rate of moderate or severe exacerbations compared to placebo. Nucala is now the only approved biologic studied in a broad COPD population with a blood eosinophil count starting at 150 cells/μL. This milestone expands treatment options for COPD patients inadequately controlled on inhaled therapies.
https://www.gsk.com/en-gb/media/press-releases/nucala-mepolizumab-approved-by-us-fda/
Pfizer and Moderna Expand mRNA Manufacturing in the EU
Moderna has secured a tender for the supply of its mRNA COVID-19 vaccine in the European Union, Norway, and North Macedonia. The agreement allows participating countries to access Moderna's vaccine over a four-year period, with options for pre-filled syringe formats to enhance vaccination campaign efficiency. This move aims to diversify mRNA vaccine supply and strengthen health security across Europe
AstraZeneca Pilots AI-Driven Batch Review Process
AstraZeneca is piloting an AI-driven project to pre-screen batch records for compliance trends and exception detection across its sites in Sweden and the UK. This initiative is part of AstraZeneca's broader strategy to leverage data science and artificial intelligence to enhance research and development processes, aiming to accelerate the delivery of innovative medicines.
AstraZeneca🔗 AstraZeneca Data Science & AI
NHS Aseptic Services
New Pharmacy Aseptic Unit: The Great Western Hospital has completed construction of a new pharmacy aseptic unit, with the first dose expected to be dispatched in August 2025. Great Western Hospitals NHS Trust
SPS QA Bite-Size Learning Event: An upcoming event on June 27, 2025, will focus on investigating deviations and establishing root causes in aseptic services. SPS - Specialist Pharmacy Service
Recalls in Pharma
Teva UK Recalls Salbutamol 2.5mg Nebules – Contamination Risk (Class 1)
Teva UK has issued a Class 1 recall for its Salbutamol 2.5mg Nebules due to potential microbial contamination. This contamination poses a significant risk of respiratory infections, especially in vulnerable patients. Healthcare professionals are advised to cease distribution and return affected batches immediately.
FDA Warning to Intas Pharmaceuticals (India)
The FDA has issued a warning letter to Intas Pharmaceuticals following an inspection that revealed serious cGMP violations. Findings included falsified stability data, inadequate cleaning procedures, and discrepancies between employee interviews and official records. These violations have led to a review of several US-bound
AvKare Eye Drops Recall – Sterility Concerns (Class II)
AvKare has voluntarily recalled over 1.8 million cartons 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. While no adverse events have been reported, the FDA has classified this as a Class II recall, indicating that use of these products may cause temporary or medically reversible adverse health
Training & Development
NSF's Pharmaceutical Law and Administration Course: Held from May 12-16, 2025, this virtual training provided insights into navigating legal and administrative challenges in the pharmaceutical sector. LinkedIn
QPQuandary's Annual Discussion Meeting: On May 22, 2025, QPQuandary hosted its 27th Annual Discussion Meeting, featuring updates from MHRA's Ian Jackson on recent regulatory changes. LinkedIn
📅 Upcoming Conferences
ISPE Europe Annual Conference 2025: Scheduled in London, this conference will feature a workshop on substances of concern and sustainability, discussing the impact of proposed PFAS bans and other regulations. ISPE
31st Annual Medicines for Europe Conference: Taking place in Brussels on June 25-26, 2025, the conference will focus on building a resilient health union, emphasizing security, access, and competitiveness. medicinesforeurope.com
🥗 GMP in Food
The FDA has issued warnings about the food recall system's inefficiencies, highlighting that current methods fail to effectively inform consumers, with communication breakdowns being a major issue. Food & Wine
🧠 Fun Pharma Fact of the Week
The FDA's recent approval of the first blood test for Alzheimer's disease marks a significant advancement in non-invasive diagnostics, potentially transforming standard detection and care practices. U.S. Food and Drug Administration+2Verywell Health+2AP News+2
📝 Summary
This edition covered the pharmaceutical industry's push towards sustainability, significant regulatory updates from MHRA, EMA, and FDA, critical product recalls, and upcoming events and training opportunities. Stay tuned for more insights in our next edition.
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