Compliance Corner Edition 11
Welcome to Edition #11 of GMP Compliance Corner — your weekly roundup for staying informed and inspection-ready. Last week, we explored What is a QP? with our resident Qualified Person, Adam — and your fantastic feedback keeps us motivated to build even more practical content for you every week.
Introduction
Welcome to Edition #11 of GMP Compliance Corner — your weekly roundup for staying informed and inspection-ready.
Last week, we explored What is a QP? with our resident Qualified Person, Adam — and your fantastic feedback keeps us motivated to build even more practical content for you every week.
This week, we’re excited to highlight two big milestones:
Over 1,500 followers on our company LinkedIn page
So close to hitting 1,000 subscribers to this newsletter!
If you find this newsletter valuable, please share it with your network and help us cross that 1,000 mark — your support makes this community thrive.
In this edition, we look ahead to a brand-new entry in one of our most popular topics: Interview Model Answers and Techniques. Plus, we cover key updates from the MHRA, EMA, and FDA, share critical recalls, and flag new training and conference opportunities to keep your knowledge sharp.
Regulatory Updates
MHRA (UK)
Real-World Data Consultation – Final Week to Respond The MHRA’s consultation on using real-world data in clinical trials closes soon. Early industry feedback supports using routine patient records and observational data to speed up approvals, especially for rare diseases. Sponsors are encouraged to review how this could affect trial design and post-marketing evidence. Read more: https://www.gov.uk/government/consultations/use-of-real-world-data-to-support-clinical-trials
New Inspectorate Case Study: Data Integrity Failings The Inspectorate has released a new blog post detailing common pitfalls found during GMP inspections. The case study highlights weak password controls, shared logins for HPLC systems, and poor audit trail reviews. Expect sharper scrutiny on these points in future inspections. Read more: https://mhrainspectorate.blog.gov.uk/
EMA (EU)
EMA Approves 12 New Medicines in May The CHMP’s latest meeting recommended 12 new marketing authorisations, including advanced therapies for oncology, haematology, and rare genetic conditions. The EMA continues to prioritise faster access through rolling reviews and orphan designations. Read more: https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-27-30-may-2025
EMA Finalises AI Guidance Framework The EMA and Heads of Medicines Agencies have finalised a framework for using artificial intelligence in regulatory submissions. The plan includes standards for algorithm validation, explainability, and human oversight during dossier review. Read more: https://www.ema.europa.eu/en/human-regulatory/research-development/artificial-intelligence
FDA (USA)
FDA Expands Remote Interactive Evaluations Following lessons from the COVID-19 pandemic, the FDA announced it will expand the use of remote evaluations for overseas sites — including video tours and live Q&A sessions with site staff. This complements physical inspections and aims to reduce inspection backlogs. Read more: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guidance/remote-interactive-evaluations-drug-manufacturers
First-in-Class ALS Treatment Approved The FDA has approved a new gene therapy for ALS (amyotrophic lateral sclerosis), designed to target the SOD1 mutation. This breakthrough brings a novel mechanism of action for slowing disease progression in this devastating condition. Read more: https://www.fda.gov/news-events/press-announcements
News from Pharma
GSK’s RSV Vaccine Gains UK Approval for Older Adults GSK’s RSV vaccine has been approved in the UK for adults aged 60 and over. This makes GSK the first to launch a licensed RSV vaccine for this population in the UK, addressing rising hospitalisations linked to respiratory syncytial virus in the elderly. Rollout is expected before the winter season. Read more: https://www.gsk.com/en-gb/media/press-releases/gsk-rsv-vaccine-approved-in-uk/
Pfizer Announces $3 Billion Antibiotics Manufacturing Boost Pfizer will invest $3 billion to expand its Michigan antibiotic facility — part of a push to re-shore critical drug manufacturing to the U.S. and reduce dependence on overseas API suppliers. The site will produce beta-lactam antibiotics and supply the U.S. Strategic National Stockpile. Read more: https://www.pfizer.com/news/press-release/press-release-detail/pfizer-invests-3-billion-expand-us-manufacturing
Moderna Files for mRNA Flu Vaccine in Europe Moderna has submitted its first mRNA-based influenza vaccine dossier to the EMA. Early trials suggest better immunogenicity compared to standard flu jabs. If approved, this would be the first mRNA flu vaccine on the European market. Read more: https://www.modernatx.com/en-US/media-center/all-press-releases
Sanofi Partners with OpenAI to Build AI Drug Discovery Platform Sanofi has announced a strategic partnership with OpenAI and Formation Bio to accelerate target discovery and lead optimisation. This collaboration aims to combine large language models with Sanofi’s internal chemical libraries to streamline candidate screening. Read more: https://www.sanofi.com/en/media-room/press-releases
NHS Aseptic & SPS Updates
Medicines and Infusions Project – Progress Report NHS England’s Medicines and Infusions Project continues to advance its goal of standardising and scaling up aseptic preparation services. Recent regional updates highlight increased collaboration between NHS trusts, implementation of hub-and-spoke models, and pilot sites testing centralised batch production of monoclonal antibodies and chemotherapy doses. This work supports resilience and consistent quality nationwide. Read more: https://www.england.nhs.uk/long-read/national-medicines-optimisation-opportunities-2023-24/
SPS Publishes New QA Podcast Episode The Specialist Pharmacy Service (SPS) has released a fresh episode in its Quality Assurance podcast series. This episode focuses on Good Distribution Practice (GDP) for aseptic products, covering cold chain considerations, transit validations, and the importance of robust SOPs when handling patient-specific compounded medicines. Read more: https://www.sps.nhs.uk/articles/podcast-series-quality-assurance-in-aseptic-services/
SPS Training Resources – Aseptic Services SPS has updated its resource library with practical guidance on environmental monitoring frequency, operator training logs, and change control checklists for small aseptic units. These templates help local QA teams align with national audit expectations. Read more: https://www.sps.nhs.uk/home/
Recalls in Pharma
MHRA (UK)
1. Propofol 1% Emulsion – Particulate Contamination (Class 1) B. Braun has issued a Class 1 recall for certain batches of Propofol 1% after visible particles were detected during in-process checks. Intravenous administration of particulates poses embolism and inflammatory risks. Healthcare providers are advised to quarantine affected stock immediately. Read more: https://www.gov.uk/drug-device-alerts/class-1-medicines-recall-b-braun-propofol-1-emulsion
2. Morphine Sulfate Oral Solution – Labelling Error (Class 2) Torbay Pharmaceuticals recalled batches of morphine sulfate 10mg/5mL oral solution due to a label error listing incorrect dosage instructions. Misuse could result in under- or overdosing, especially in palliative care. Read more: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-torbay-pharmaceuticals-morphine-sulfate-oral-solution
FDA (USA)
1. Lupin Pharmaceuticals – Cefdinir Oral Suspension Contamination Lupin has voluntarily recalled select lots of cefdinir for oral suspension after routine testing found contamination with Pseudomonas. The antibiotic is commonly prescribed for pediatric infections, increasing the risk for vulnerable patients. Read more: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lupin-pharmaceuticals-inc-issues-voluntary-nationwide-recall
2. Santen Ophthalmic Products – Sterility Assurance Failure Santen has pulled multiple lots of ophthalmic drops due to inadequate sterility assurance during manufacturing. This poses a risk of severe eye infections. The FDA recommends patients stop use and return affected products. Read more: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/santen-inc-issues-voluntary-nationwide-recall-specific-lots
EMA / EU Market
1. Metformin Extended-Release – NDMA Impurity Risk Several EU countries have recalled batches of extended-release metformin after elevated NDMA levels were detected. NDMA is a probable human carcinogen linked to long-term exposure. Read more: https://www.ema.europa.eu/en/news/precautionary-recalls-metformin-containing-medicines
2. Omeprazole Capsules – Stability Failures A precautionary recall was triggered in parts of Europe for generic omeprazole 20mg capsules due to out-of-specification results during ongoing stability studies. The affected batches showed reduced potency before expiry. Read more: https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/quality-defects
Training & Learning Opportunities
NSF Pharma Biotech – Data Integrity and Digitalisation Workshop This one-day virtual workshop explores how to implement robust data integrity controls in an era of digital batch records, AI-assisted reviews, and remote audits. Includes practical exercises and a live Q&A with ex-MHRA inspectors. Read more: https://www.nsf.org/training/pharma-biotech/data-integrity-workshop
QP Quandary – New June Case Study The latest QP Quandary tests your judgement on whether to release a sterile batch when an environmental excursion occurred during vial filling. Participants can submit their reasoning and compare with real-world expert decisions. Read more: https://www.qpquandary.com
Help Me GMP – New Interview Series Launch Don’t forget, our new video this week revives our popular Interview Model Answers and Techniques series — watch, pause, and practice your answers with real pharma QA/QC examples. Watch here: https://youtube.com/@HelpMeGMP
Upcoming Conferences
ISPE Pharma 4.0 & Annex 1 Conference – Vienna, June 17–18, 2025 A key event for QA, production, and validation professionals. Sessions will cover real-world challenges in implementing Pharma 4.0 principles, digital batch records, and robust contamination control aligned with Annex 1. Read more: https://ispe.org/conferences/2025-pharma-40-annex1
31st Annual Medicines for Europe Conference – Brussels, June 25–26, 2025 This year’s theme focuses on medicine security and supply resilience. Stakeholders will discuss EU policy trends, generics competitiveness, and access equity. Read more: https://www.medicinesforeurope.com/events/31st-annual-conference-2025
PDA EU Sterile Medicinal Products Conference – Berlin, July 8–9, 2025 A must-attend for those working with sterile products. Topics include sterile process validation, single-use systems, and trends in contamination recovery. EMA regulators and global experts will share inspection case studies. Read more: https://www.pda.org/global-event-calendar
GMP in Food
FDA Publishes Updated Draft Guidance on Food Traceability The FDA has released an updated draft guidance expanding requirements for high-risk foods under the Food Traceability Rule. It includes stricter recordkeeping and faster trace-back protocols for items like leafy greens, soft cheeses, and nut butters. This aims to close gaps found in recent recall response audits. Read more: https://www.fda.gov/food/food-safety-modernization-act-fsma/food-traceability-rule
EU to Tighten Additive Limits in Food Supplements The European Food Safety Authority (EFSA) has recommended new limits for titanium dioxide and certain artificial dyes in food supplements. Manufacturers may need to reformulate or prove safety with updated toxicology data. Read more: https://www.efsa.europa.eu/en/news
Detailed Audit Readiness Tip
Spotlight: SOP Version Control and Training Matrix Alignment
One of the most common findings during MHRA and FDA inspections is misalignment between SOP versions and staff training records. Even in well-run sites, inspectors often uncover examples where:
An old SOP version is still in circulation in a cleanroom or QC lab.
A new starter is signed off on an outdated training module.
The site’s training matrix hasn’t been updated to match recent SOP revisions.
How to get audit-ready this week:
Check Document Distribution: Physically spot-check your SOP folders, controlled printouts, and electronic versions especially in production areas, labs, and on trolleys.
Cross-Verify Training Matrix: Select a random SOP. Verify the version number against your E-QMS (such as Ideagen , Veeva Systems , Qualio, Scilife) or a paper master copy. Then cross-check at least three operators’ training records for that SOP.
Communicate Updates Quickly: If you find mismatches, issue a controlled communication for example, a ‘Change Notification’ email or staff briefing and document the re-training. Keep this evidence ready for inspectors.
Why this matters: Regulators expect absolute control of documents version control failures can lead to deviations, rework, or critical observations. Proving tight document control and live training status shows your QMS works in practice.
Fun Pharma Fact of the Week
Did you know? A single cleanroom operator can shed up to 10 million skin flakes and micro-organisms per day — one reason gowning and strict cleanroom behaviour are so critical in GMP manufacturing.
Summary & Call to Action
That wraps up Edition #11 — packed with regulatory news, fresh recalls, new training links, and a heads-up on the return of our Interview Model Answers and Techniques video series.
Follow Help Me GMP on LinkedIn: https://www.linkedin.com/company/helpmegmp ✅
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See you next Monday for Edition #12 — stay compliant, stay curious, and keep sharing your feedback.