GMP Compliance Corner – Edition 15
Intro: Building Confidence, No Experience Required We’ve had a busy but exciting week at Help Me GMP. Our latest video in the Interview Model Answers series is live and it’s built specifically for beginners with no prior GMP or GDP experience. If you’re new to the industry (or know someone who is), this is the one to share.
GMP Compliance Corner - What is Good Manufacturing Practice?
Intro: Building Confidence, No Experience Required
We’ve had a busy but exciting week at Help Me GMP. Our latest video in the Interview Model Answers series is live and it’s built specifically for beginners with no prior GMP or GDP experience. If you’re new to the industry (or know someone who is), this is the one to share.
We’ve also officially started posting our GMP Shorts on TikTok, helping us reach a whole new generation of professionals in quick, under-60-second clips.
And finally, Adam Walker’s full podcast appearance on The QP Diaries is now available a must-watch if you’re curious about Qualified Person responsibilities in the NHS.
Thank you for continuing to support this project.
Regulatory Updates
MHRA (UK)
Class 2 medicines recall – Zaditen 0.25 mg/mL eye-drops Published 7 July 2025. 11 360 packs from batch 4V64 are being withdrawn after an out-of-spec environmental-monitoring result raised a microbial-contamination risk during manufacture. Action is at pharmacy and wholesaler level; patients need take no action unless symptoms occur. Full notice: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-zaditen-0-dot-25-mg-slash-ml-eye-drops-solution-laboratoires-thea-el-25-a-slash-34 GOV.UK
Common-specification requirements for IVD devices On 10 July 2025 the MHRA released new “common specifications” detailing performance and labelling expectations for high-risk in-vitro diagnostics placed on the GB market. Manufacturers should align technical files before the future UKCA transition deadlines. Update: https://www.emergobyul.com/news/uk-mhra-publishes-common-specification-requirements-ivd-devices Emergo by UL
EMA (EU)
Ixchiq chikungunya vaccine – age-restriction lifted 11 July 2025: PRAC concluded its review and removed the temporary restriction on vaccinating adults ≥65 years. Use in older adults is now permitted when significant exposure risk exists and benefits outweigh risks. News: https://www.ema.europa.eu/en/news/ixchiq-temporary-restriction-vaccinating-people-65-years-older-be-lifted European Medicines Agency (EMA)
PRAC July meeting highlights (7 – 10 July 2025) Key outcomes included the Ixchiq decision above and routine signal-management updates for Imfinzi, Levetiracetam Accord and other centrally authorised medicines. Summary: https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-7-10-july-2025 European Medicines Agency (EMA)
FDA (USA)
Spikevax (Moderna COVID-19 vaccine) – updated approval letter 9 July 2025: FDA issued a new approval letter and decisional memo reflecting the latest strain-composition update and post-marketing commitments. Documents: https://www.fda.gov/vaccines-blood-biologics/spikevax (see “July 9 2025 Approval Letter”) U.S. Food and Drug Administration
Draft guidance on aluminum in parenteral-nutrition products 9 July 2025: CDER released draft guidance Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations; comments are open until September 2025. PDF: https://www.fda.gov/media/163799/download U.S. Food and Drug Administration
Complete-response letter for Capricor’s deramiocel (DMD therapy) 11 July 2025: FDA declined to approve deramiocel for Duchenne cardiomyopathy, citing insufficient efficacy data and outstanding CMC issues. Capricor will submit additional phase III results. Press coverage: https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-declines-approve-capricors-muscle-disorder-therapy-2025-07-11/ Reuters
News from Pharma
Merck buys Verona Pharma in $10 billion deal Merck announced a definitive agreement to acquire Verona Pharma for about $10 billion, adding first-in-class COPD maintenance therapy Ohtuvayre (ensifentrine) to its cardio-pulmonary pipeline and promising double-digit growth into the next decade. Merck.com
Novartis wins first-ever malaria approval for newborns Swissmedic has fast-tracked Coartem Baby for infants weighing 2–5 kg — closing a long-standing treatment gap for the youngest malaria patients and paving the way for roll-outs across eight African countries. Novartis
FDA clears KalVista’s Ekterly (sebetralstat) The agency approved the first and only oral on-demand therapy for hereditary angio-oedema attacks, ending a turbulent review that missed its original PDUFA date. Analysts peg peak sales at up to $700 million. Drugs.com
Pfizer launches post-pandemic structural overhaul Pfizer is dissolving its standalone Corporate Affairs division and folding key functions into business units to cut overheads, speed decision-making and restore pre-pandemic margins under CEO Albert Bourla’s “focus, speed, simplicity” agenda. AInvest
CEL-SCI signs Saudi partnership for Multikine Shares jumped 67 % after CEL-SCI unveiled a strategic deal with a leading Saudi pharmaceutical firm to advance Multikine for head-and-neck cancer and announced a 1-for-30 reverse stock split aimed at boosting share price stability. AInvest
Recalls in Pharma
MHRA – United Kingdom
Product: Zaditen 0.25 mg/mL eye-drops, batch 4V64 (Laboratoires Théa).
Classification: Class 2 medicines recall.
Reason: An out-of-spec environmental-monitoring result indicated a potential microbial-contamination risk during manufacture.
Scope & action: 11,360 packs distributed; recall applies at pharmacy and wholesaler level. Patients need take no action unless they experience symptoms. Quarantine remaining stock and return via the normal recall process; report any adverse events through the Yellow Card scheme.
NHS Aseptics & SPS Updates
Temperature‑Controlled Storage of Medicines – Upcoming QA Bite-Size
SPS will host a QA “bite-size” WebEx session on 25 July 2025, from 13:00–14:00, focused on best practices for temperature-controlled storage in clinical and aseptic settings.
Particularly relevant for units managing fridge lines, cold-chain processes, or Annex 1 compliance reviews.
Register here: https://www.sps.nhs.uk/articles/temperature-controlled-storage-of-medicines/
Biosimilars & Key Generic Medicines Webinar – Recording Now Available
The 9 July 2025 webinar discussed NHS implementation of biosimilars and key generics, with practical considerations for aseptic preparation services.
Includes guidance on procurement planning, QA batch record updates, and technical considerations.
Watch and access resources: https://www.sps.nhs.uk/articles/biosimilar-and-key-generic-medicines-july-2025-update/
Applications Open: Writing the Next QAAP Standards
RPS have opened a call for contributors to help shape the next version of the Quality Assurance of Aseptic Preparation Services (QAAP) standards.
A fantastic opportunity for experienced professionals in QA, aseptics, and technical services to influence national practice.
Register interest via RPS: https://www.rpharms.com/about-us/contact-us/get-involved
Training & Learning – Upcoming Opportunities
Temperature-Controlled Storage of Medicines (SPS QA Bite-Size)
25 July 2025 – WebEx, 13:00–14:00 BST
Practical walk-through of GDP/GMP expectations for fridge lines, cold-chain packaging and in-process monitoring — essential for aseptic and clinical pharmacy teams. Register: https://www.sps.nhs.uk/articles/temperature-controlled-storage-of-medicines/ ISPE
PDA Annex 1 Implementation: “Inspection-Ready” Workshop
14 – 15 July 2025 – Online, 09:00–12:00 EDT each day
Two-day workshop blending presentations and break-out sessions on contamination-control strategy, CCS documentation and inspector interview prep. Details: https://www.pda.org/global-event-calendar/event-detail/annex1-implementation-inspection-ready-workshop Default
ISPE Hands-On Aseptic Processing & Annex 1 Training Course
23 – 25 September 2025 – Strasbourg, France
In-depth, small-group course covering aseptic technique, barrier technology, CCS, and media-fill troubleshooting, fully aligned with the 2023 Annex 1 revision. Info & booking: https://ispe.org/calendar
Detailed Audit Readiness Tip
Focus Area: Personnel Qualification & Gowning Validation
Inspectors know that even the best facilities are only as clean as the people working inside them. Use this self-contained checklist to confirm your programme will stand up to scrutiny.
Initial Qualification Records: Verify every Grade A/B operator file contains a signed observation checklist, successful gowning-validation plates and (where required) media-fill participation.
Re-Qualification Schedule: Check that glove/gown micro counts and aseptic-technique assessments are on time; any overdue or failed result must trigger documented retraining before the next cleanroom entry.
Gowning SOP vs Real Practice: Observe a live gown-up (or review CCTV) and confirm each step matches the validated sequence look for silent deviations such as skipping the alcohol spray or touching mask edges after donning gloves.
Microbial Trending: Trend glove and gown counts by operator for at least six months; flag repeat excursions and ensure root-cause CAPAs or coaching notes are in place.
Trigger-Based Retraining: Make sure your SOP forces retraining after any media-fill failure, out-of-spec glove/gown count, or audit observation QA must sign off the retraining, not just a line manager.
Documentation Links: Confirm every personnel file references the current gowning SOP version; if the SOP has been revised, the file must show when (and how) each operator was re-trained.
Why this matters: Personnel-borne contamination remains a top cause of sterility-test failures and Annex 1 findings. A watertight, data-driven qualification programme shows inspectors your cleanroom isn’t just clean by design—it’s clean because your people are proven to keep it that way.
Fun Pharma Fact
The word “placebo” comes from a Latin hymn… and originally meant “I shall please.”
In 14th-century religious texts, “placebo Domino” meant “I shall please the Lord.” The word gradually evolved to describe something that pleases but may lack substance. By the late 1700s, “placebo” entered medical use to refer to treatments that had no direct effect, but were given to soothe or reassure patients.
Today, the placebo effect is so powerful that it's used as the benchmark in almost all clinical trials meaning even billion-dollar drugs must prove they work better than “I shall please.”
Summary & Close
Thank you for sticking with us through another packed edition of GMP Compliance Corner. From new regulatory updates and industry recalls to NHS aseptic news and audit readiness tips, we’re proud to keep you informed with the insights that matter.
We’re especially excited to be back on track with fresh videos, including our latest Interview Model Answers and the start of our TikTok Shorts series. And if you missed it, be sure to check out Adam Walker’s podcast interview on AssureBio QP Diaries a brilliant deep dive into the real-life challenges of Qualified Person decision-making.
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