GMP Compliance Corner #12
Welcome to Edition #12 of GMP Compliance Corner. We want to take a moment to share something important with our community: over the past couple of weeks, you may have noticed that our usual weekly main video didn’t go live. That’s because, like many of you, we balance this project alongside our demanding day jobs, family time, and personal commitments and sometimes, life simply has to come first.
Introduction
Help Me GMP has always been and will remain a passion project: free, independent, and created purely in our own time to help demystify GMP and share knowledge with as many people as possible. We’re incredibly grateful for your patience and understanding when things run a little slower than usual.
This week, we’re aiming to get our popular Shorts series back on track and, if all goes to plan, we’ll follow up with the next installment of our Interview Model Answers series very soon.
Thank you for sticking with us your support keeps this community strong and growing!
Coming This Week
We’re planning to get back into the swing of things with more fresh content this week.
First up our GMP Basics Shorts series will be restarting, so watch out for quick, clear explainer clips perfect for sharing with your team or refreshing your own knowledge in under a minute.
We’re also lining up the next installment in our popular Interview Model Answers & Techniques series. These videos break down real-life answers, what interviewers are looking for, and practical ways to stand out in pharma QA, QC, and production interviews.
While you wait, if you haven’t watched it yet, don’t miss Adam Walker's video on What It Is to Be a QP. It’s a must-see if you want to understand the real responsibilities and decision-making power behind the Qualified Person role. Watch here: https://youtube.com/@HelpMeGMP
Regulatory Updates
MHRA (UK)
New GDP Blog on Temperature Excursions The MHRA Inspectorate has published a new Good Distribution Practice (GDP) blog discussing how to manage temperature excursions in transit. It highlights common failings seen in inspections, including poor root cause analysis and incomplete CAPAs. Expect more focus on transit qualification in upcoming GDP and GMP inspections. Read more: https://mhrainspectorate.blog.gov.uk/2025/06/10/gdp-inspections-and-temperature-excursions/
New Enforcement Action – Unlicensed Manufacturing The MHRA recently took enforcement action against an unlicensed compounding pharmacy supplying high-risk sterile products without the necessary GMP authorisation. This case underscores the agency’s zero-tolerance approach to unlicensed manufacturing of injectables. Read more: https://www.gov.uk/government/news
EMA (EU)
First CRISPR Gene Therapy Approved in Europe The EMA has granted marketing authorisation for the first CRISPR-based gene therapy for beta-thalassemia. This milestone highlights the regulator’s commitment to advanced therapy approvals under the PRIME scheme. Inspectors will pay close attention to viral vector traceability and GMP for ATMPs. Read more: https://www.ema.europa.eu/en/news/first-crispr-gene-therapy-approved-europe
EMA Publishes Draft Guidance on Remote Audits The EMA released draft guidelines on using remote and hybrid GMP audits for suppliers. This clarifies expectations for documentation, live-streamed facility tours, and how remote audits can support qualification without replacing on-site inspections completely. Read more: https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-remote-gmp-audits_en.pdf
FDA (USA)
New Guidance on Continuous Manufacturing The FDA has finalised new guidance on continuous manufacturing for small-molecule drugs. The document details control strategies, real-time monitoring, and how companies can submit batch equivalence data. This aims to modernise outdated batch-by-batch production lines. Read more: https://www.fda.gov/media/164341/download
FDA Approves First Subcutaneous RSV Treatment for Adults The FDA has approved a new subcutaneous RSV monoclonal antibody injection for high-risk adults, a breakthrough for preventing severe RSV infections outside hospital settings. Rollout is expected before the 2025 winter season. Read more: https://www.fda.gov/news-events/press-announcements
News From Pharma
Pfizer Partners with Thermo Fisher on Advanced Manufacturing Pfizer has announced a multi-year strategic partnership with Thermo Fisher Scientific to develop and scale up next-generation continuous manufacturing platforms. This aims to increase flexibility, reduce lead times, and strengthen supply resilience for critical medicines. Read more: https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-strategic-partnership-thermo-fisher
AstraZeneca to Build New R&D Hub in Cambridge AstraZeneca has unveiled plans for a £500 million investment in a new Cambridge campus focused on AI-driven drug discovery and biologics R&D. The facility will include cutting-edge GMP suites to rapidly pivot from lab-scale to pilot production. Read more: https://www.astrazeneca.com/media-centre/press-releases/2025/astrazeneca-announces-500m-investment-in-cambridge-uk.html
Novartis Launches Carbon-Neutral Manufacturing Pilot Novartis has started a pilot program at its Basel site to test carbon-neutral utilities for cleanrooms and lab operations. The project uses renewable energy, improved HVAC controls, and heat recovery to meet sustainability goals without compromising GMP conditions. Read more: https://www.novartis.com/news/media-releases
GSK Expands Vaccine Production Capacity in Belgium GSK will expand its Wavre facility, Europe’s largest vaccine manufacturing site, adding capacity for its RSV and flu vaccine lines. The expansion is backed by EU funding to ensure faster response to seasonal outbreaks and future pandemics. Read more: https://www.gsk.com/en-gb/media/press-releases/gsk-expands-vaccine-manufacturing-in-belgium/
Recalls In Pharma
MHRA (UK)
1. Paracetamol 500 mg Tablets – Foreign Particulate Contamination (Class 2) A Class 2 recall has been issued for batches of generic paracetamol 500 mg tablets manufactured by a UK contract packer. Routine visual inspections revealed embedded black and grey particles within some tablets, likely from a production line maintenance lapse. While no patient harm has been reported to date, the presence of foreign particulate poses a risk of throat injury or gastrointestinal irritation. Pharmacies are advised to quarantine remaining stock and arrange returns to the supplier. Read more: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-paracetamol-500mg-tablets
2. Lidocaine Injection – Strength Labelling Error (Class 2) The MHRA has announced a Class 2 recall for Lidocaine 1% Injection ampoules mislabelled as 2% by the secondary packaging contractor. This error significantly increases the risk of accidental overdose during local anaesthetic administration, particularly in dental or minor surgical settings. Healthcare professionals should immediately isolate affected lots and inform relevant clinical staff to prevent patient harm. Read more: https://www.gov.uk/drug-device-alerts
FDA (USA)
1. Lupin Pharmaceuticals – Cefdinir Oral Suspension Contamination Lupin Pharmaceuticals expanded its nationwide voluntary recall of cefdinir for oral suspension 250mg/5mL after additional routine quality control testing confirmed contamination with Pseudomonas aeruginosa. This bacterium can cause severe infections in immunocompromised or pediatric patients, who are the main recipients of this broad-spectrum antibiotic. Pharmacists are instructed to check inventory, stop distribution, and contact patients if needed. Read more: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts
2. Cardinal Health – Monoject Syringes Sterility Breach Cardinal Health has initiated a voluntary Class I recall — the FDA’s highest risk category — for certain lots of Monoject syringes after internal sterility assurance testing failed. Affected syringes could potentially introduce pathogens when used for medication injection or aspiration. Healthcare facilities must stop using stock immediately and report any adverse events to the FDA’s MedWatch system. Read more: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts
EMA / EU Market
1. Valsartan Tablets – NDMA Impurity Detected Again An EU-wide recall has been triggered for multiple batches of valsartan tablets after confirmatory tests showed NDMA (N-nitrosodimethylamine) contamination above acceptable daily intake limits. NDMA is classified as a probable human carcinogen. EU regulators urge pharmacists to switch patients to unaffected alternatives and monitor stock returns closely. This incident renews attention on API supply chain oversight, especially with imports from certain third-country manufacturers. Read more: https://www.ema.europa.eu/en/news/valsartan-containing-medicines-some-batches-recalled-precaution
2. Metformin XR – Dissolution Stability Failure Authorities in several EU member states have recalled lots of metformin extended-release tablets after ongoing stability studies showed that the tablets failed to maintain dissolution rates within specification. This raises concerns about subtherapeutic blood glucose control in diabetic patients relying on consistent extended-release performance. Patients are advised not to stop medication abruptly but to seek pharmacist advice for a safe switch to unaffected batches. Read more: https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/quality-defects
NHS Aseptics & SPS Updates
SPS QA Bite-Size Session – Investigating Deviations and Root Causes The NHS Specialist Pharmacy Service (SPS) will host a live QA Bite-Size session on June 27, 2025, focusing on how to properly investigate deviations and establish robust root causes in aseptic preparation units. The session will cover real examples, trending techniques, and practical tips to strengthen CAPA effectiveness. This is highly recommended for QA managers, aseptic supervisors, and trainee QPs. Register here: https://www.sps.nhs.uk/events/qa-bite-size-investigating-deviations-and-establishing-root-cause/
NHS to Expand Clinical Trials via NHS App Announced on June 16, 2025, the Department of Health and Social Care (DHSC) confirmed new plans to allow patients to sign up for approved clinical trials directly through the NHS App. This aims to streamline recruitment for trials, including those involving aseptic production of novel therapies. Read more: https://www.gov.uk/government/news/nhs-app-to-offer-access-to-clinical-trials
Training and Learning Opportunities
NSF – Aseptic Processing Refresher (June 25, 2025) NSF is running a half-day virtual refresher next week covering the latest Annex 1 updates, practical media fill strategies, and real inspection case studies. Ideal for aseptic supervisors, QA auditors, and production leads wanting a concise expert-led update. Register here: https://www.nsf.org/training/pharma-biotech
QP Quandary – June Scenario: Contaminated Fill Line This month’s QP Quandary challenges you to decide whether to release a sterile batch after a documented clean-in-place deviation during vial filling. You can submit your decision and see how it compares to real QP reasoning and MHRA expectations. Try the scenario: https://www.qpquandary.com
Help Me GMP – Interview Model Answers Series Returns Don’t miss the return of our popular Interview Model Answers & Techniques video series this week. We break down realistic GMP interview questions and show you how to craft answers that stand out. Subscribe here: https://youtube.com/@HelpMeGMP
Upcoming Conferences
ISPE Pharma 4.0 & Annex 1 Conference – Vienna, June 17–18, 2025 Focuses on real-world Pharma 4.0 implementation, digital batch records, and contamination control aligned with the revised Annex 1. Includes practical case studies and regulator insights. Read more: https://ispe.org/conferences/2025-pharma-40-annex1
EPIC Pharma Auditors Training – Ongoing 2025 Events EPIC offers highly regarded classroom and virtual training for GMP auditors, QPs, and QA managers. Topics include risk-based auditing, advanced data integrity inspections, and best practices for writing clear audit reports. Sessions run throughout the year across the UK and EU. Read more: https://epic-auditors.com/
NSF Pharma Biotech Conference – London, October 2025 NSF’s flagship conference for pharma and biotech professionals returns this autumn. Key topics: evolving data integrity threats, inspection trends, and sustainability in GMP operations. Read more: https://www.nsf.org/knowledge-library/nsf-pharma-biotech-conference-2025
31st Annual Medicines for Europe Conference – Brussels, June 25–26, 2025 Brings together regulators, generics industry leaders, and policy makers to discuss medicine security and competitive supply chains within the EU. Read more: https://www.medicinesforeurope.com/events/31st-annual-conference-2025
Detailed Audit Readiness Tip
Focus Area: Cleaning Validation and Ongoing Verification
Cleaning validation is a top priority for both MHRA and FDA inspectors because inadequate or poorly maintained cleaning programmes are a frequent root cause of cross-contamination incidents and costly product recalls. It is not enough to validate a cleaning process once and file it away regulators expect clear evidence that your validated cleaning methods are still robust under real production pressures.
Here is a practical readiness checklist to focus on this week:
Alignment of SOPs with the Validation Protocol: Re-read your approved cleaning SOPs and compare them line by line with the original validation report and master plan. Look for silent deviations such as:
Routine Swab and Rinse Sampling: Pull at least three months of routine cleaning verification results. Confirm that:
Cleaning Records and Operator Practices: Physically check cleaning logbooks on the production floor and in the washroom areas. Pay attention to:
Cross-Department Coordination: Confirm that Production, QA, and Validation teams communicate any changes in batch sizes, new product introductions, or new formulations that might affect cleaning requirements. This coordination must be documented through formal meetings or change requests.
Why this matters: Regulatory inspectors routinely ask for evidence that cleaning remains validated throughout the lifecycle of equipment use. Any mismatch between protocol, SOPs, operator practice, and verification results can result in serious inspection findings and, in worst cases, batch rejection or market recall. Keeping this process watertight demonstrates your QMS is alive and effective.
GMP in Food
FDA Issues New Guidance on Allergen Control in Ready-to-Eat Foods
The FDA has published updated draft guidance reinforcing GMP expectations for controlling cross-contact allergens in ready-to-eat food production lines. This follows a rise in recalls linked to undeclared allergens, now the most frequent cause of food product recalls in the US market. Key measures include validated cleaning protocols between product changeovers, clear allergen labelling, and training all line operators on cross-contact risks. This guidance aligns closely with preventive control principles in 21 CFR Part 117 and is likely to shape future site inspections for companies producing both allergen-containing and allergen-free lines. Read more: https://www.fda.gov/food/cfsan-constituent-updates/fda-releases-draft-guidance-allergen-control
Fun Pharma Fact of the Week
Did you know?
The term "Pharmacopoeia" comes from Greek roots meaning "to make a drug." The first recognised European pharmacopoeia was published in 1546 in Nuremberg, Germany, listing standard preparations for apothecaries laying the foundation for today’s GMP principles of standardisation, control, and repeatability.
Summary
This edition of GMP Compliance Corner covered important ground. We shared an honest update on our commitment to free, accessible GMP knowledge, even when life demands a pause, and outlined our plan to get our Shorts and Interview Model Answers series back on track.
We highlighted major regulatory news from the MHRA, EMA, and FDA, new developments across the pharmaceutical industry, and critical recalls that reinforce the need for strong routine inspections and supplier oversight. NHS Aseptic and SPS updates focused on current, timely resources and training opportunities. We also included a detailed audit readiness checklist for cleaning validation and an update on how food GMP lessons connect back to core pharma principles.
We appreciate everyone who reads, shares, and subscribes to this newsletter. We are close to reaching 1,000 subscribers, so please pass this on to colleagues who would benefit.
Stay sharp, stay compliant, and see you in the next edition.