GMP Compliance Corner - Edition #16 Building a Community for Compliance

Welcome to Edition 16 of GMP Compliance Corner and thank you again for being part of this growing newsletter family. This week, we’re excited to announce something new: the launch of our Help Me GMP LinkedIn Community Group.

We know that compliance can feel complex and isolating, especially if you’re new to GMP or working in a small QA or production team. That’s why we’ve created a space where you can ask questions, swap ideas, and learn from others across the industry. Whether you’re facing a documentation challenge, prepping for an audit, or building your career in GMP you’re not alone. Come join the conversation.

Join the Help Me GMP LinkedIn Community - https://www.linkedin.com/groups/13021291/

Meanwhile, we’re back this week with our usual mix of:

Up-to-date regulatory news from the MHRA, EMA, and FDA

The latest pharma recalls across the UK, EU, and US

NHS and SPS aseptic updates you need to know

A powerful audit readiness tip focused on out-of-spec investigations

A new Fun Pharma Fact to close us out with a smile

Regulatory Updates (13 – 20 July 2025)

MHRA (UK)

Adrenaline (epinephrine) nasal spray approved – first needle-free rescue option for anaphylaxis (18 Jul 2025). The MHRA granted a national licence for EURneffy 2 mg single-dose nasal spray, providing patients ≥30 kg a rapid, non-injectable alternative to auto-injectors. Authorised via the International Recognition Procedure, the product must be supplied as a twin-pack and carries standard Yellow Card monitoring commitments. https://www.gov.uk/government/news/mhra-approves-adrenaline-nasal-spray-the-first-needle-free-emergency-treatment-for-anaphylaxis-in-the-uk GOV.UK

Sebetralstat (Ekterly) oral on-demand HAE therapy authorised (15 Jul 2025). First UK-approved oral treatment for hereditary angio-oedema attacks; approved for patients ≥12 years following Access Consortium work-sharing. It blocks plasma kallikrein to halt attacks rapidly and reduces need for injectable rescue. https://www.gov.uk/government/news/mhra-approves-sebetralstat-ekterly-to-treat-hereditary-angioedema-hae-attacks-in-patients-aged-12-and-over GOV.UK

EMA (EU)

July 2025 list of new MAAs under evaluation published (data cut-off 17 Jul). Fresh applications now being assessed by CHMP include BNT163 (first maternal CMV mRNA vaccine), mavacamten 2.5 mg ODT, and tembexor (oral STF-1 inhibitor for AML). Sponsors should check procedural timetables and clock-stop deadlines. https://www.ema.europa.eu/en/documents/report/applications-new-human-medicines-under-evaluation-july-2025_en.xlsx European Medicines Agency (EMA)

Advanced-Therapy Committee (CAT) agenda released for 16–18 Jul meeting. Public agenda shows rapporteur assignments for three new CAR-T candidates (BCMA, GPRC5D, Claudin-18.2) and two CRISPR-edited stem-cell products, signalling an active Q3 pipeline. https://www.ema.europa.eu/en/documents/agenda/agenda-cat-meeting-16-18-july-2025_en.pdf European Medicines Agency (EMA)

FDA (USA)

Elevidys gene-therapy safety action (18 Jul 2025). After three deaths from acute liver failure, FDA placed Sarepta’s AAVrh74 trials on full clinical hold and formally asked the company to halt commercial distribution of Elevidys for Duchenne muscular dystrophy; Sarepta declined to comply. The agency also revoked the firm’s Platform Technology Designation. https://www.fda.gov/news-events/press-announcements/fda-requests-sarepta-therapeutics-suspend-distribution-elevidys-and-places-clinical-trials-hold U.S. Food and Drug Administration

Advisory committee votes 10-1 against brexpiprazole + sertraline for PTSD (18 Jul 2025). The Psychopharmacologic Drugs Advisory Committee concluded efficacy was not demonstrated; FDA will decide but typically follows panel advice. https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-18-2025-meeting-psychopharmacologic-drugs-advisory-committee-meeting-announcement-07182025 U.S. Food and Drug Administration

News from Pharma (13 – 20 July 2025)

Sanofi completes US $4.6 billion acquisition of Blueprint Medicines Sanofi has closed its tender offer for Blueprint Medicines, adding systemic-mastocytosis drug Ayvakit, a KIT-driven oncology pipeline and 500 R&D staff to its rare-disease franchise. The deal strengthens Sanofi’s position in precision oncology ahead of its 2026 revenue-doubling plan. Long-form link: https://www.sanofi.com/en/media-room/press-releases/2025/2025-07-18-05-00-00-3117709 Sanofi

Thermo Fisher to buy Sanofi’s Ridgefield, NJ sterile-fill site Thermo Fisher Scientific will acquire Sanofi’s U.S. sterile-drug product plant, adding >200 employees and boosting domestic fill-finish capacity for both Sanofi products and CDMO clients. The transaction expands a multi-year strategic partnership aimed at securing U.S. supply resilience. Long-form link: https://www.pharmaceuticalcommerce.com/view/thermo-fisher-sanofi-expand-partnership-boost-sterile-drug-production PharmaCommerce

Roche gets Complete Response Letter for Columvi + GemOx in DLBCL FDA rejected Roche’s sBLA seeking to add Columvi (glofitamab) plus GemOx for second-line diffuse large B-cell lymphoma in transplant-ineligible patients, citing the need for additional efficacy and CMC data. Roche says it will work with FDA on next steps but expects a delay of at least 12 months. Long-form link: https://www.roche.com/investors/updates/inv-update-2025-07-18 Roche

AstraZeneca’s anti-CD38 antibody anselamimab misses Phase III primary endpoint The CARES programme in AL amyloidosis failed to show a statistically significant benefit for anselamimab in overall hematologic response versus standard of care; AstraZeneca will halt further investment and reallocate resources to its next-generation ADC pipeline. Long-form link: https://www.astrazeneca.com/media-centre/press-releases/2025/update-on-anselamimab-in-al-amyloidosis.html AstraZeneca

Boehringer Ingelheim and LEO Pharma sign global licence for SPEVIGO® The partners announced an exclusive licence and transition agreement giving LEO Pharma worldwide rights to spesolimab (SPEVIGO) for generalised pustular psoriasis, aiming to broaden patient access while Boehringer focuses on other immunology assets. Long-form link: https://www.leo-pharma.com/media-center/news/2025-boehringer-ingelheim-and-leo-pharma-enter-partnership Leo Pharma

Pfizer & Bristol Myers launch “Eliquis 360” direct-to-patient model The companies unveiled a new service that ships Eliquis directly to patients’ homes at a discounted price, paired with nurse hot-lines and adherence tools, an early test of hybrid distribution models ahead of U.S. pharmacy benefit reforms. Long-form link: https://www.pharmexec.com/view/pfizer-bristol-myers-squibb-launch-direct-patient-eliquis

MHRA – United Kingdom

No new Class 1 or Class 2 medicines recalls were issued by the MHRA during the past seven days. (Latest alert remains the Zaditen eye-drops Class 2 recall of 7 July 2025.)

EMA / EU Member States

No centrally published drug‐product recalls were announced by EMA or reported by national agencies in the EU over the last week.

FDA – United States

The FDA did not post any new prescription-drug or biologic recalls between 13 and 20 July 2025.

NHS Aseptics & SPS Updates (13 – 20 July 2025)

1. Last call to register – Temperature-Controlled Storage of Medicines Event date 25 July 2025 • WebEx, 13:00–14:00 BST SPS QA Bite-Size will walk through GDP/GMP expectations for fridge lines, cold-chain packaging and routine temperature monitoring all directly relevant to aseptic units preparing Annex 1 compliance evidence. Fewer than 40 virtual seats remain. Full details & free registration: https://www.sps.nhs.uk/articles/temperature-controlled-storage-of-medicines/ SPS - Specialist Pharmacy Service

2. Contribute to the next QAAP standards – applications still open The Royal Pharmaceutical Society (RPS) and SPS are recruiting experienced QA, aseptic and technical-services professionals to help draft the next edition of Quality Assurance of Aseptic Preparation Services (QAAP) guidance. Expressions of interest are being accepted through 31 July 2025. More info & application form: https://www.rpharms.com/about-us/news/details/Call-for-expressions-of-interest-to-develop-the-next-QAAPS-guidance

Training & Learning — Upcoming Opportunities

Temperature-Controlled Storage of Medicines (SPS QA Bite-Size) 25 July 2025 · WebEx, 13:00–14:00 BST A practical walk-through of GDP/GMP expectations for fridge lines, transport packaging and routine monitoring — ideal preparation for winter audits. Register → https://www.sps.nhs.uk/articles/temperature-controlled-storage-of-medicines/

PDA Annex 1 “Inspection-Ready” Virtual Workshop 14 – 15 August 2025 · Online, 09:00–12:00 EDT each day Two half-day sessions covering contamination-control strategy, cleanroom qualification and mock inspector interviews. Details → https://www.pda.org/global-event-calendar/event-detail/annex1-implementation-inspection-ready-workshop

RSSL QP Hot-Topic Webtorial – Annex 1 Validation Pitfalls 4 September 2025 · Online, 09:30–12:30 BST Focused CPD on the top Annex 1 deviations seen in recent MHRA inspections: media-fill gaps, disinfection-validation errors and gowning-plate trends. Book → https://www.rssl.com/life-science-training-consultancy/life-science-courses/qp-hot-topic-webtorial

Cleanroom Behaviour & Comportment for Aseptic Services 1 October 2025 · Weetwood Hall Estate, Leeds One-day TSET/University of Leeds course on cleanroom entry, behaviour and critical-zone discipline — perfect for new aseptic staff or refresher training. Info & booking → https://eps.leeds.ac.uk/short-course/4042/cleanroom-behaviour-and-comportment-for-aseptic-services

ISPE Annual Meeting & Expo 2025 (Hybrid) 26 – 29 October 2025 · Orlando, Florida / Online Tracks on digital QMS, ATMP facilities, continuous manufacturing and post-2023 Annex 1 lessons, plus an FDA/EMA regulator round-table. Programme → https://ispe.org/conferences/2025-annual-meeting

Call for Contributors – Next QAAP Standards (RPS / SPS) Expressions of interest close 31 July 2025 Shape the next national guidance for Quality Assurance of Aseptic Preparation Services. Apply → https://www.rpharms.com/about-us/news/details/Call-for-expressions-of-interest-to-develop-the-next-QAAPS-guidance

Detailed Audit Readiness Tip

Focus Area: Audit-Trail Review & Data-Integrity Verification

Data integrity is a standing hot-button for MHRA, FDA, and EMA inspectors. They will ask to see evidence that your electronic audit trails are reviewed, exceptions investigated, and any gaps closed. Use this checklist — each point is fully self-contained so no information is lost when you copy and paste.

Inventory of Audit-Trail Locations: Create (or update) a master list of every system that generates GMP data — HPLC, LIMS, warehouse WMS, EMS, SCADA, e-BR, QMS and confirm an audit-trail review SOP exists for each. Reference: MHRA GxP Data-Integrity Guidance, March 2024, Section 5 – https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1144579/MHRA_GxP_data_integrity_guidance_Mar_2024.pdf

Routine Review Frequency Defined: Verify the SOP spells out how often audit trails are reviewed (e.g., batch-by-batch for QC instruments; weekly for EMS; monthly for QMS changes) and that QA signs off the schedule. A blanket “periodically” will draw criticism.

Exception Reports Demonstrate Critical Thinking: Pull three exception reports from the past quarter. Each should show: what triggered the event, who investigated, root cause, and CAPA. If the investigation text just says “operator error – retrained,” expect a finding.

Restricted User Access & Administrator Oversight: Check admin-role assignment logs. Inspectors will scan for unauthorised privilege escalation or “shared admin” accounts. Every admin role must be traceable to a named, trained individual.

Automated Timestamp Verification: Confirm system clocks are locked and synchronised (e.g., NTP server). FDA routinely requests proof that audit-trail times match site time; a five-minute drift can raise data-integrity flags.

Backup & Archival Testing: Locate evidence that backups are performed, restored, and verified on a pre-defined schedule. A backup that has never been test-restored is a data-integrity risk.

Retraining Triggers & QA Oversight: Ensure your SOP mandates retraining whenever an audit-trail exception investigation cites human error. QA must approve the retraining plan and confirm effectiveness.

Why this matters In 2024–2025, over 40 % of FDA 483s for sterile sites cited inadequate audit-trail review or weak electronic record controls. A robust, documented review process demonstrates that your data are complete, consistent, and accurate the foundation of product quality and patient safety.

The word “pharmacy” comes from ancient Greek — but the roots go deeper.

The term “pharmakon” (φάρμακον) in Ancient Greek had a curious double meaning: it referred to both a remedy and a poison. This reflected the understanding, even thousands of years ago, that dose and context determine whether a substance heals or harms, an idea now formalised in the phrase “the dose makes the poison” from 16th-century scientist Paracelsus.

In modern GMP-regulated manufacturing, this concept still underpins everything, from potency assays to cleaning validation, reminding us that control is what keeps a medicine therapeutic.

ChatGPT said:

Summary & Close – Edition 16

This week marks another step forward for Help Me GMP as we continue to build tools, share insight, and create spaces for connection. In the past seven days:

We launched our brand-new LinkedIn community group to give GMP professionals a space to ask questions, swap ideas, and support one another across QA, QC, Production, and aseptics. → Join the conversation here: https://www.linkedin.com/groups/14399717/

We kept the momentum going on our TikTok Shorts, offering bite-sized GMP knowledge that’s easy to share and quick to learn.

And of course, our YouTube channel is still growing fast long-form content, interview breakdowns, and in-depth GMP walkthroughs. → Watch and subscribe: https://www.youtube.com/@HelpMeGMP

We’re so grateful to everyone subscribing, reading, and sharing each edition of GMP Compliance Corner. Every comment, repost, and bit of feedback helps keep this project alive and truly independent.

Thank you for being part of this journey. See you next week!

Kyle Winn / Adam Walker

WinnPharma @PharmaQP