GMP Compliance Corner #13 - No Shortcuts, Just Shorts

Introduction Help Me GMP has always been and will always remain a passion project: Free, Independent and Created purely in our own time Our goal is simple: to demystify GMP and share practical knowledge with as many people as possible. This week, we’re aiming to get our GMP Shorts series back on track. And if all goes to plan, we’ll follow up with the next part of our Interview Model Answers series very soon. Thank you for sticking with us — your support keeps this community strong and growing.

WinnPharma

6/30/20259 min read

Introduction

Help Me GMP has always been and will always remain a passion project:

Free, Independent and Created purely in our own time

Our goal is simple: to demystify GMP and share practical knowledge with as many people as possible.

This week, we’re aiming to get our GMP Shorts series back on track. And if all goes to plan, we’ll follow up with the next part 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 getting back into the swing of things — and you may have already noticed the return of our GMP Basics Shorts series! These quick, under-a-minute explainers are designed to be clear, practical, and ideal for sharing with your team or refreshing your own knowledge on the go.

Next up, we’re lining up the next installment of our Interview Model Answers & Techniques series. This one’s still in the works — but it’s coming soon. These videos are built to help you stand out in QA, QC, and production interviews, breaking down real-life answers and what hiring managers are really looking for.

Regulatory Updates

MHRA (UK) Operation Pangea: 7.7 million illegal doses seized A 25 June press release reports that MHRA, working with INTERPOL and 90 countries, confiscated 7.7 million doses of illicit medicines, froze £1.4 million in criminal profits and closed 367 websites. The agency signals continued criminal-enforcement focus on online sales and transit routes. Read more: https://www.gov.uk/government/news/mhra-seizes-77-million-doses-of-illegal-medicines-and-removes-hundreds-of-illegal-online-listings-as-part-of-operation-pangea (gov.uk)

AI Airlock and a new global AI regulator network On 27 June MHRA announced an expanded “AI Airlock” sandbox plus membership of a new worldwide network aimed at sharing safety signals for AI-enabled medical devices. Sponsors can now apply for the next AI Airlock cohort. Read more: https://www.gov.uk/government/news/ai-airlock-cersis-and-a-new-global-ai-network-for-health-regulators (gov.uk)

EMA (EU) Draft ICH M4Q(R2) guideline released for consultation The updated Common Technical Document Quality module (59 pages) was released on 25 June. Key additions: integrated development summary, expanded lifecycle-management section and clearer expectations for analytical-procedure descriptions. Comment deadline is 24 October 2025. Read more: https://www.ema.europa.eu/en/documents/scientific-guideline/ich-m4q-guideline-common-technical-document-registration-pharmaceuticals-human-use-quality-step-2b_en.pdf (ema.europa.eu)

CTIS Newsflash – transition to monthly “Clinical Trials Highlights” The 24 June newsflash confirms that the bi-weekly CTIS bulletin will be replaced in July. It also flags unplanned system downtime on 26 June and a redesigned sponsor handbook due 9 July. Read more: https://www.ema.europa.eu/en/documents/newsletter/ctis-newsflash-24-june-2025_en.pdf (ema.europa.eu)

FDA (USA) REMS requirement removed for all licensed CAR T therapies On 27 June FDA concluded that existing labeling and boxed warnings are sufficient to manage CRS and neuro-toxicity risks, eliminating the REMS program for Abecma, Breyanzi, Carvykti, Kymriah, Tecartus and Yescarta. This should ease site certification burdens. Read more: https://www.fda.gov/news-events/press-announcements/fda-eliminates-risk-evaluation-and-mitigation-strategies-rems-autologous-chimeric-antigen-receptor (fda.gov)

Updated myocarditis and pericarditis warning for mRNA COVID-19 vaccines On 25 June FDA required Comirnaty and Spikevax to add real-world incidence data (about 8 cases per million doses) and longer-term cardiac MRI findings. Fact sheets for the paediatric EUA products have been aligned accordingly. Read more: https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-approves-required-updated-warning-labeling-mrna-covid-19-vaccines-regarding-myocarditis-and (fda.gov)

News From Pharma

AstraZeneca expands Bengaluru operations with 400 new jobs Global biopharma AstraZeneca is investing Rs 166 crore (about £15.5 million) to enlarge its Bengaluru hub, adding AI-driven R&D, digital-health capability and 400 new positions. Read more: https://timesofindia.indiatimes.com/city/bengaluru/astrazeneca-invests-rs-166-crore-to-expand-bengaluru-operations/articleshow/122097862.cms (timesofindia.indiatimes.com)

Torrent Pharma to acquire controlling stake in JB Chemicals Torrent Pharmaceuticals will purchase 46.39 % of JB Chemicals from KKR in a deal valuing JB at $3 billion, followed by a planned merger to bolster Torrent’s Indian footprint. Read more: https://www.reuters.com/business/healthcare-pharmaceuticals/indias-torrent-pharma-acquire-controlling-stake-jb-chem-pharma-2025-06-29/ (reuters.com)

Pfizer reports Phase 3 success for HYMPAVZI in haemophilia with inhibitors Once-weekly marstacimab cut annualised bleeding rates by 93 % versus on-demand care and met all key endpoints in the BASIS trial for haemophilia A and B patients with inhibitors. Read more: https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-positive-topline-phase-3-results (pfizer.com)

Sanofi’s riliprubart gains FDA orphan-drug designation The C1s-inhibiting antibody received orphan status for treating antibody-mediated rejection in solid-organ transplantation, supporting an ongoing Phase 2 kidney-transplant study. Read more: https://www.sanofi.com/en/media-room/press-releases/2025/2025-06-25-05-00-00-3104793 (sanofi.com)

Bharat Biotech and GSK to halve Mosquirix malaria-vaccine price The partners will reduce the dose price to below $5 by 2028 via technology transfer and expanded capacity, aiming to accelerate roll-out across Africa. Read more: https://www.reuters.com/business/healthcare-pharmaceuticals/bharat-gsk-halve-price-malaria-vaccine-by-2028-2025-06-25/ (reuters.com)

Vetter breaks ground on US$285 million clinical-manufacturing site in Illinois The CDMO’s new 160,000-sq-ft Des Plaines facility will add early-phase aseptic-filling capacity and is expected to be media-fill ready by the end of 2029. Read more: https://www.biospace.com/press-releases/vetter-marks-the-start-of-new-clinical-site-construction-with-groundbreaking-ceremony (biospace.com)

Recalls in Pharma

MHRA (United Kingdom)

1. Depo-Medrone 80 mg/2 mL suspension for injection – label strength mismatch (Class 2)

2. Kimmtrak 200 micrograms/mL concentrate for infusion – potency drift (Class 3)

EU (Market notice – France, ANSM)

Cefpodoxime Teva Children 40 mg/5 mL powder for suspension – potential loss of bottle integrity

FDA (United States)

Cefazolin for Injection 1 g vials – mis-packaging with Penicillin G vials

NHS Aseptics & SPS Updates

SPS QA Services Newsletter & Quality‑Share Updates

SPS QA continues to collaborate with NHS England, MHRA, DHSC, and CQC to share learnings from aseptic audit and inspection activities.

  • Findings from the recent Quality Assurance & Technical Services Symposium (QATS) were shared among NHS hospital pharmacy teams and Trust technical services, covering key inspection trends and sector-wide improvement actions sps.nhs.uk

  • Pre‑recorded videos covering contamination control, worksheet design, deviation management, and internal audit remain available through SPS and support ongoing team training sps.nhs.uk

Stability Tools & Aseptic Service Support

SPS has refreshed its Stability Information tool—offering updated data on shelf life and environmental conditions for various aseptic preparations, aiding batch expiry management in Section 10 units sps.nhs.uk Additional guidance is maintained on the SPS site, including Yellow Cover documents, ATMP preparation, cytotoxic stability, and aseptic service governance via iQAAPS sps.nhs.uk

Training & Learning

1. Safer Use of Time‑Critical Medicines

Date: 1 July 2025 (Time TBC) Overview: An SPS learning event exploring how to safely manage and improve use of time-sensitive medicines across the NHS. Event listing: https://www.sps.nhs.uk/articles/spotlight-june-2025/

2. Time‑Critical Medicines Quality Improvement Collaborative

EOI deadline: 30 June 2025 (tomorrow) Intro webinar: 8 July 2025, 14:00–15:00 Overview: National QI initiative to improve delivery and risk management of time‑critical medicines via projects in NHS Trusts. More info & EOI form: https://www.sps.nhs.uk/articles/time-critical-medicines-quality-improvement-collaborative/

3. Biosimilar & Key Generic Medicines Update

Date: 9 July 2025, 13:00–14:00 (WebEx) Overview: National webinar discussing new biosimilars (e.g., aflibercept, denosumab) and their implementation for 2025/26. Register here: https://www.sps.nhs.uk/events/biosimilar-and-key-generic-medicines-update-9-july-2025/

4. Temperature‑Controlled Storage of Medicines Session

Date: 25 July 2025, 13:00–14:00 (WebEx) Overview: Covers best practice for storing medicines under controlled temperature conditions in line with GDP and GMP—ideal for aseptic units and pharmacy teams. Register here: https://www.sps.nhs.uk/events/qa-bite-size-temperature-controlled-storage-of-medicines-25-july-2025/

Upcoming Conferences & Meetings

1. NHS QA Symposium 2025 (Annual Event)

  • Date: September 2025 (exact dates TBC)

  • Location: Likely Midlands-based (past events in Birmingham/Leicester)

  • Overview: National event for QA professionals in NHS Technical Services. Includes sessions on GMP, MHRA inspections, validation, aseptic strategy, and technical governance.

  • Host: NHS Pharmaceutical QA Committee

  • Registration: Details to be posted via https://www.sps.nhs.uk and Trust QA contacts.

2. PharmSci 2025 (UKICRS + Academy of Pharmaceutical Sciences)

  • Date: 11–13 September 2025

  • Location: University of Strathclyde, Glasgow

  • Overview: Covers pharmaceutical science, manufacturing, regulatory science, and novel delivery technologies.

  • Details: https://www.apsgb.co.uk/pharmsci/

3. ISPE Annual Meeting & Expo 2025

  • Date: 26–29 October 2025

  • Location: Orlando, Florida, USA

  • Overview: Focuses on pharmaceutical manufacturing, digital transformation, GMP, and aseptic processing. International attendance, with strong EU and UK GMP relevance.

  • Details: https://ispe.org/conferences/2025-annual-meeting

4. PDA Universe of Pre-Filled Syringes & Injection Devices

  • Date: 21–22 October 2025

  • Location: Palm Springs, California, USA

  • Overview: Industry-leading event for injectable device technology, combination products, aseptic filling, and container-closure integrity.

  • Details: https://www.pda.org/global-event-calendar

5. Clinical Pharmacy Congress 2025 (UK NHS-focused)

  • Date: 2–3 October 2025

  • Location: ExCeL London

  • Overview: Covers NHS pharmacy strategy, education, prescribing, clinical trials, and aseptic services. Large UK attendance.

  • Details: https://www.pharmacycongress.co.uk/

Detailed Audit Readiness Tip

Focus Area: Change Control Effectiveness

Change control is a cornerstone of your Quality Management System and one of the first things regulators look at to assess whether you're running a reactive or proactive operation. Both MHRA and FDA expect more than just paperwork; they want to see critical thinking, traceability, and real-world impact assessment.

Here’s a practical readiness checklist to focus on this week:

Change Categorisation and Risk Assessment

  • Review the last 10 closed change controls. Were they correctly categorised as minor, major, or critical?

  • Check if the risk assessments clearly justify the category — or if it's just assumed based on past examples.

  • Bonus points: Make sure the rationale links back to the QRM process or FMEA if applicable.

Impact Across Functions

  • Pull one complex change e.g. a formulation tweak, new equipment, or layout change and map who was involved.

  • QA, Production, QC, Validation, and Procurement should all be looped in when relevant.

  • Inspectors often flag incomplete assessments where departments weren’t consulted or notified in time.

Linkage to Supporting Documents

  • For each change, check that the linked SOPs, specs, protocols, and training records are listed, updated, and version-controlled.

  • A common weakness: change control says "SOP updated" but the actual SOP version still reflects the old process.

  • Use a traceability matrix or checklist to close this gap.

Training and Communication Evidence

  • Randomly select a few changes and verify that affected staff were trained before go-live, not after.

  • Look for gaps between “Effective Date” and when training was logged auditors notice this.

  • Cross-reference change controls with LMS or training logs.

Effectiveness Checks and Close-Out

  • Are you doing post-implementation reviews for medium and high-risk changes?

  • Examples: batch record review, deviation tracking, informal interviews with users.

  • If not, build this into your process. Effectiveness checks show inspectors that your change control is alive and working not just a document signed off.

Why this matters:

A weak change control system suggests your QMS is reactive and siloed. Inspectors want to see a controlled, risk-based, and collaborative approach to every change — whether it's a minor edit to a SOP or a major facility upgrade. Strong change control isn't about saying yes or no… it's about knowing why.

GMP in Food: Lessons for Pharma

FDA Issues New Guidance on Allergen Control in Ready-to-Eat Foods The FDA has released updated draft guidance on preventing cross-contact with allergens in ready-to-eat (RTE) food production — now the leading cause of food recalls in the US. The guidance emphasises:

  • Validated cleaning protocols between product changeovers

  • Clear allergen labelling aligned to finished product specs

  • Operator training on cross-contact risks and visual inspection

It aligns closely with 21 CFR Part 117 and will influence future inspections for dual-allergen or allergen-free lines. Pharma teams can draw parallels with GMP principles around line clearance, cleaning validation, risk communication, and traceability. Read more: https://www.fda.gov/food/cfsan-constituent-updates/fda-releases-draft-guidance-allergen-control

Fun Pharma Fact of the Week

The first recorded GMP guidelines didn’t come from a regulator they came from a military manual.

In 1941, the U.S. Army published strict quality requirements for penicillin production to ensure safe supplies for troops during WWII. These wartime controls eventually evolved into the FDA’s formal GMP rules in the 1960s.

So yes you can thank penicillin and the army for kickstarting the modern GMP movement.

Summary

This edition of GMP Compliance Corner covered essential updates across the GMP landscape:

  • An honest reflection on our progress with GMP Shorts and Interview Model Answer videos

  • Regulatory alerts from MHRA, EMA, and FDA, including enforcement and new guidances

  • Major industry headlines across pharma manufacturing and supply

  • High-risk product recalls in the UK, EU, and US — with practical learning points

  • NHS Aseptic Services and SPS updates, with upcoming events and new tools

  • This week’s Audit Readiness Tip on Cleaning Validation

  • And even a reminder from the food sector about why routine, validated cleaning matters

We’re grateful for every reader, and we’re incredibly close to 1,000 subscribers. If this newsletter has helped you, please consider sharing it with a colleague or tagging us on LinkedIn.

Stay sharp. Stay compliant. See you next week.

Kyle Winn

Help Me GMP | GMP, GDP, Pharma and Aseptic Training | HelpMeGMP

WinnPharma

Subscribe here: https://www.linkedin.com/newsletters/gmp-compliance-corner-7152873361323208704

YouTube: https://www.youtube.com/@HelpMeGMP