GMP Compliance Corner – Edition #18
We took a short break from the GMP Compliance Corner last week to enjoy some family time, but we’re back this week with Edition #18. It’s packed with the latest GMP, GDP, and regulatory updates, NHS aseptic news, and a detailed audit readiness tip to keep your site inspection-ready. Thanks for following along your support helps us keep building a stronger GMP community.
GMP Compliance Corner – Edition #18
We took a short break from the GMP Compliance Corner last week to enjoy some family time, but we’re back this week with Edition #18.
It’s packed with the latest GMP, GDP, and regulatory updates, NHS aseptic news, and a detailed audit readiness tip to keep your site inspection-ready.
Thanks for following along your support helps us keep building a stronger GMP community.
What Went Live in the Last 2 Weeks
Here’s what we’ve released recently on the Help Me GMP YouTube channel:
What Does the Head of Production REALLY Do in Pharma? Explore the day-to-day responsibilities and leadership role of a Head of Production in a licensed pharmaceutical manufacturing facility. Watch here: https://youtu.be/jrE22Tt81hk
QA vs QC Explained | What’s the Difference in Pharma? A quick breakdown of the differences between Quality Assurance and Quality Control. Watch here: https://youtube.com/shorts/zNxE6uwMXPo?feature=share
Data Integrity in GMP | Key Elements Explained Simply Understand the essential components of data integrity and why they matter in compliance. Watch here: https://youtube.com/shorts/tomcwtf55Gw?feature=share
MHRA, FDA, EMA Explained | The Role of Regulators in Pharma Learn the role of major pharmaceutical regulators around the world. Watch here: https://youtube.com/shorts/JuBsPPxRpOg?feature=share
What is the difference between GMP, cGMP, and EU GMP? Find out how these terms differ and what they mean in practice. Watch here: https://youtube.com/shorts/yC6L8enownU?feature=share
Key Principles of GMP | GMP Basics A beginner-friendly breakdown of the core principles of Good Manufacturing Practice. Watch here: https://youtube.com/shorts/yMSSOM0SV3c?feature=share
GMP/GDP/Regulatory News (last 7 days)
• FDA launches “PreCheck” to support onshoring drug manufacturing Read more: https://www.fda.gov/news-events/press-announcements/fda-announces-new-fda-precheck-program-boost-us-drug-manufacturing.
• FDA says the IV saline shortage has been resolved Read more: https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-marty-makary-md-mph-announcing-resolution-iv-saline-solutions-shortage.
• FDA grants accelerated approval to dordaviprone for diffuse midline glioma Read more: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-dordaviprone-diffuse-midline-glioma.
• MHRA designated as a WHO-Listed Authority Read more: https://www.gov.uk/government/news/mhra-designated-as-who-listed-authority-a-milestone-for-uk-life-sciences-and-global-health. GOV.UK
• MHRA and NICE outline plan to speed NHS patient access to medicines by 3–6 months Read more: https://www.gov.uk/government/news/patients-will-receive-medicines-3-6-months-faster-under-10-year-health-plan-as-regulators-set-out-plans. GOV.UK
• EMA updates procedural advice and forms for Paediatric Investigation Plans Procedural advice PDF: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/procedural-advice-paediatric-applications_en.pdf What’s new overview: https://www.ema.europa.eu/en/news-events/whats-new.
• EMA publishes August 2025 list of new human medicines under evaluation Download: https://www.ema.europa.eu/en/documents/report/applications-new-human-medicines-under-evaluation-august-2025_en.xlsx Overview of update: https://www.ema.europa.eu/en/news-events/whats-new.
• EMA issues Medicine Shortage Communication on Zypadhera (olanzapine pamoate) Read more: https://www.ema.europa.eu/en/documents/other/medicine-shortage-communication-msc-zypadhera-olanzapine-pamoate-monohydrate-powder-solvent-prolonged-release-suspension-injection_en.pdf.
NHS Aseptic & SPS Updates (last 7 days)
• Cytarabine: informing intrathecal risk assessment Updated with licensed products and risk-assessment detail for intrathecal use (5 Aug 2025). Read more: https://www.sps.nhs.uk/articles/cytarabine-informing-intrathecal-risk-assessment/
• Amikacin: informing intrathecal risk assessment New intrathecal risk-assessment monograph live (5 Aug 2025). Read more: https://www.sps.nhs.uk/articles/amikacin-informing-intrathecal-risk-assessment/
• New Medicines News – July 2025 issue posted Horizon scanning bulletin page updated (7 Aug 2025). Read more: https://www.sps.nhs.uk/articles/new-medicines-news/
• Safer use of time-critical medicines Event page updated with latest info (7 Aug 2025). Read more: https://www.sps.nhs.uk/articles/safer-use-of-time-critical-medicines-2/
• PGD template: Folic acid 5 mg in pregnancy Update note added to the template page (7 Aug 2025). Read more: https://www.sps.nhs.uk/articles/folic-acid-5mg-tablets-for-use-during-pregnancy/
• Upcoming: Change management in pharmacy aseptic services (Webex, 20 Aug) Registration open. Useful for production, QA, and QC teams. Read more: https://www.sps.nhs.uk/articles/change-management-in-pharmacy-aseptic-services/
Pharma Recalls (last 7 days): MHRA, FDA, EMA
• MHRA – Class 2 Medicines Recall: Fucidin 250 mg Tablets (LEO Pharma) Reason: out-of-specification impurities found during stability testing. Issued 4 August 2025. Read more: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-fucidin-250-mg-tablets-leo-laboratories-ltd-trading-as-leo-pharma-el-25-a-slash-38.
• MHRA – Class 4 Medicines Defect Notification: Topiramate 20 mg/ml Oral Solution (Zydus) Reason: artwork error on outer carton and Patient Information Leaflet. Issued 7 August 2025. Read more: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-notification-topiramate-zydus-pharmaceuticals-uk-20mg-slash-ml-oral-solution-zydus-pharmaceuticals-uk-ltd-el-25-a-slash-39.
• FDA – DermaRite Industries recalls multiple OTC antiseptic soaps and cleansers Reason: contamination with Burkholderia cepacia. Posted 9 August 2025. Read more: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dermarite-industries-issues-voluntary-nationwide-recall-dermakleen-dermasarra-kleenfoam-and.
• EMA – No EMA product recall notices in the last 7 days Closest relevant EU action: Medicine Shortage Communication on Zypadhera (olanzapine pamoate), noting ongoing supply constraints following a resolved quality issue. Published 7 August 2025. Read more: https://www.ema.europa.eu/en/documents/other/medicine-shortage-communication-msc-zypadhera-olanzapine-pamoate-monohydrate-powder-solvent-prolonged-release-suspension-injection_en.pdf
Upcoming Training & Conferences (10 Aug – 10 Sep 2025)
• Change management in pharmacy aseptic services — 20 Aug 2025, 13:00–14:00 (UK), Online (Webex). Read more: https://www.sps.nhs.uk/articles/change-management-in-pharmacy-aseptic-services/
• PDA/FDA Joint Regulatory Conference 2025 — 8–10 Sep 2025, Washington, DC. Read more: https://www.pda.org/global-event-calendar/save-the-date/pda-regulatory-conference-2025
• ISPE – HVAC for Pharma Facilities (T14) — 19–21 Aug 2025, Online Live. Read more: https://ispe.org/training
• ISPE – Basic GAMP 5, Annex 11/Part 11 (T45) — 1–3 Sep 2025, Online Live. Read more: https://ispe.org/training/2025-september
• ISPE – GMP Fundamentals (G01) — 2–5 Sep 2025, Online Live. Read more: https://ispe.org/training/2025-september
• ISPE – Cleaning Validation Principles (T17) — 8–11 Sep 2025, Online Live. Read more: https://ispe.org/training/2025-september
• ISPE – Pharmaceutical Water Generation (T04) — 9–12 Sep 2025, Online Live. Read more:https://ispe.org/training/2025-september
Detailed Audit Readiness Tip
Topic: Change control evidence
What inspectors ask to see
At least one recent high-impact change from start to finish.
Risk assessment, validation outcome, training, and a post-implementation review.
Common pitfalls
Generic risk assessments.
Validation with no predefined acceptance criteria.
SOP updated but forms, labels, or master data not updated.
Training done but competence not checked.
Change closed while CAPAs remain open.
What good looks like
One pack: summary, traceability, risk assessment specific to the change.
Validation plan and report with clear pass or fail.
Document updates with effective dates, plus training and competence evidence.
Batch impact and stakeholder communication.
Review after 30–90 days with simple trend check.
Quick self-check
Can a new QA colleague find the pack in 5 minutes.
Do dates and versions align across all records.
For aseptic changes: CCS and EM impact addressed.
Fun Pharma Fact
The “c” in cGMP means “current.” Regulators use cGMP to signal that GMP expectations evolve. A process that was acceptable a few years ago may no longer meet current standards.
Quick takeaway: pick one SOP this week and check if it reflects current guidance, technology, and risk.
Summary
Edition 18 is back after a short family break. New content includes a deep dive on the Head of Production role plus Shorts on QA vs QC, Data Integrity, regulators, GMP vs cGMP vs EU GMP, and key GMP principles. Regulatory highlights focus on FDA’s PreCheck initiative, resolution of the IV saline shortage, MHRA’s WHO-Listed Authority status, and EMA procedural updates. NHS aseptic updates cover new intrathecal risk resources and upcoming SPS change management training. Recalls include MHRA alerts and an FDA antiseptic products recall. Training over the next month features SPS, PDA/FDA, and multiple ISPE live online courses. This week’s audit tip zeroes in on clear change control evidence. Fun fact: the “c” in cGMP means current.
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