GMP Compliance Corner – Edition #14

Introduction

We’re back and we’re recommitting to getting more long-form educational videos out to you over the coming weeks.

It’s been a busy spell behind the scenes: while our GMP Shorts have continued, full-length training content has taken a brief pause as Adam’s been overseas auditing and taking part in some exciting industry conversations.

One of those is dropping very soon and well worth a listen.

Adam recently appeared on the AssureBio QP Diaries podcast with Dal Pawar , where he spoke candidly about life as a Qualified Person in the NHS, decision-making under pressure, and the real responsibility with being a QP.

It’s one of the clearest, most human explanations of the QP role we’ve come across and it reflects everything Help Me GMP stands for: clarity, openness, and respect for the people doing the work.

Thanks for sticking with us and yes, the next training drop is on its way

Regulatory Updates

EMA (EU)

1. Ibuprofen Product-Specific Bioequivalence Guidance Updated On 1 July 2025, the EMA updated its guidance for ibuprofen immediate-release formulations (200–800 mg), including detailed recommendations on study design, analyte selection, and acceptance criteria to support generic submissions. Read more: https://www.ema.europa.eu/en/ibuprofen-product-specific-bioequivalence-guidance ema.europa.eu

2. Dolutegravir Product-Specific Bioequivalence Guidance Updated Also on 1 July, finalised guidance for dolutegravir film-coated tablets (10 mg, 25 mg, 50 mg) was published, removing the requirement for a 10 mg study and adding protocols for the 5 mg dispersible formulation. Read more: https://www.ema.europa.eu/en/dolutegravir-product-specific-bioequivalence-guidance ema.europa.eu

3. Levothyroxine Product-Specific Bioequivalence Guidance Released A new Revision 1 of levothyroxine tablets (12.5–200 µg) guidance took effect on 1 July, harmonising expectations for multi-strength bioequivalence studies under ISO IDMP standards. Read more: https://www.ema.europa.eu/en/levothyroxine-product-specific-bioequivalence-guidance ema.europa.eu

4. Synjardy (Empagliflozin/Metformin) EPAR Updated The centralised EPAR for Synjardy was revised on 1 July to reflect new post-authorisation efficacy and safety data. Read more: https://www.ema.europa.eu/en/medicines/human/EPAR/synjardy ema.europa.eu

5. Breyanzi (Lisocabtagene Maraleucel) EPAR Updated Also on 1 July, the EPAR for the CAR-T therapy Breyanzi was updated with expanded manufacturing control data under the PRIME scheme. Read more: https://www.ema.europa.eu/en/medicines/human/EPAR/breyanzi ema.europa.eu

6. NDSG Recommendations on Medicinal Product Master Data The Network Data Steering Group published its recommendations (EMA/135628/2025) on 1 July, outlining a step-wise ISO IDMP-compliant approach to centralise human medicinal product master data for better regulatory interoperability. Read more: https://www.ema.europa.eu/en/documents/other/medicinal-product-master-data-better-regulation-better-health-network-data-steering-group-ndsg-recommendations-human-product-master-data-implementation-data-management_en.pdf ema.europa.eu

FDA (USA)

1. Lynozyfic™ (linvoseltamab-gcpt) Accelerated Approval On 2 July 2025, FDA granted accelerated approval to Lynozyfic™ for adults with relapsed or refractory multiple myeloma after at least four prior lines of therapy, based on a 73 % overall response rate in the LINKER-MM1 trial. Read more: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-linvoseltamab-gcpt-relapsed-or-refractory-multiple-myeloma fda.gov

2. Sunvozertinib (Zegfrovy) Accelerated Approval Also on 2 July, FDA approved Sunvozertinib for adults with metastatic non-small cell lung cancer harbouring EGFR exon 20 insertion mutations, as detected by an FDA-approved test, following progression on platinum-based chemotherapy. Read more: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sunvozertinib-metastatic-non-small-cell-lung-cancer-egfr-exon-20

News from Pharma (30 June – 6 July 2025)

1. Pfizer & Thermo Fisher Scientific Launch Continuous Manufacturing Partnership Pfizer and Thermo Fisher Scientific have announced a multi-year strategic collaboration to co-develop and deploy next-generation continuous manufacturing platforms for small-molecule and biologic medicines. The agreement aims to increase production flexibility, reduce end-to-end lead times by up to 50 percent, and enhance supply-chain resilience for critical therapies. Initial workstreams will focus on modular skid-based units that can be rapidly reconfigured for new products. Read more: https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-strategic-partnership-thermo-fisher

2. AstraZeneca Commits £500 million to New Cambridge R&D Hub AstraZeneca has unveiled plans for a £500 million investment in a state-of-the-art research and development campus in Cambridge, UK. The facility will house AI-driven drug-discovery teams and bioprocessing laboratories with integrated GMP suites—streamlining the path from bench to pilot production. Scheduled to open in late 2026, the hub will also include collaboration spaces for academic and biotech partners. University of Cambridge Read more: https://www.astrazeneca.com/media-centre/press-releases/2025/astrazeneca-announces-500m-investment-in-cambridge-uk.html

3. Novartis Pilots Carbon-Neutral Utilities at Basel Manufacturing Site Novartis has launched a pilot programme at its Basel, Switzerland, site to test a fully carbon-neutral utility system supporting cleanrooms and laboratory operations. The initiative combines on-site solar power, heat-recovery chillers, low-emission steam generation, and enhanced HVAC controls. If successful, the model will be scaled to other large-scale GMP facilities by 2027. Read more: https://www.novartis.com/news/media-releases

4. GSK to Expand RSV & Influenza Vaccine Capacity in Belgium GlaxoSmithKline will expand its Wavre manufacturing site—the largest vaccine facility in Europe—adding two new filling lines dedicated to RSV (Arexvy/Afrezza) and seasonal influenza vaccines. Backed by €120 million in EU funding, the expansion will increase annual dose capacity by 30 million and support rapid scale-up in response to outbreak scenarios. Completion is targeted for Q1 2027. Read more: https://www.gsk.com/en-gb/media/press-releases/gsk-expands-vaccine-manufacturing-in-belgium/

5. Vetter Breaks Ground on $285 million Illinois Clinical-Manufacturing Site CDMO Vetter has commenced construction of a new US $285 million, 160,000 ft² clinical-manufacturing facility in Des Plaines, Illinois. The site will add 12 aseptic filling lines, advanced isolator technology, and automated inspection systems designed for early-phase and small-volume biologics programmes. The facility is expected to be media-fill ready by end-2029 and create 250 new jobs. Read more: https://www.biospace.com/press-releases/vetter-marks-the-start-of-new-clinical-site-construction-with-groundbreaking-ceremony

Recalls in Pharma – since 30 June 2025

MHRA (UK)

No new Class 1 or Class 2 medicines recalls were issued by the MHRA in this period.

EU (Centralised / National Agencies)

No new EU-wide or national drug recalls have been announced since 30 June 2025.

FDA (USA)

Sandoz, Inc. – Cefazolin for Injection, USP, 1 g vials

• Recall date: 27 June 2025

• Issue: One lot (PG4360) of cefazolin vials was found to contain four vials of Penicillin G Potassium for Injection, USP (20 million Units) packaged inside carton boxes labelled as cefazolin.

• Risk: Patients expecting cefazolin could receive penicillin instead, risking treatment failure, unexpected potassium load, or life-threatening anaphylaxis in penicillin-allergic individuals.

• Action: Health-care providers must immediately halt use, segregate any remaining stock, and return product via Sedgwick. Clinicians should verify any doses already administered from this lot. Read more: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sandoz-inc-issues-voluntary-nationwide-recall-one-lot-cefazolin-injection-due-product-mispackaging

NHS Aseptics & SPS Updates (from 6 July 2025)

New SPS Resource – Supporting Medicines Use in Rare Disease The Specialist Pharmacy Service (SPS) published a new page outlining how hospital and clinical pharmacists can support medicines optimisation for rare disease patients. Although not aseptic-specific, it touches on specialist supply chains, non-licensed medicine pathways, and the use of named patient and compassionate-use programmes. This resource may help QA teams and aseptic services understand supply challenges for ATMPs and orphan products. Read more: https://www.sps.nhs.uk/articles/supporting-medicines-use-in-rare-disease/

Training & Learning Opportunities

1. QP Hot Topic Webtorial

Date: 4 July 2025 (Online) A problem-solving session for QPs and trainees, led by Rebecca Rutter. July’s focus: Annex 1 hands‑on guidance through current release scenarios to sharpen decision-making and interpretation. 🔗 Register now: https://www.rssl.com/life-science-training-consultancy/life-science-courses/qp-hot-topic-webtorial/ RSSL

2. QP Expert Consultation 1-to-1

Date: 17 July 2025 (Online) A one-on-one mentoring session with experienced QPs, ideal for those preparing for viva, dealing with complex QP decisions, or needing bespoke support. 🔗 Book your session: https://www.rssl.com/life-science-training-consultancy/life-science-courses/qp-expert-consultation-1-to-1/ RSSL Training & Consultancy

3. QP Forum 2025 (Qualified Person Forum)

Dates: 27–28 November 2025 Location: Barcelona Celebrating the 50th anniversary of the QP role, this biennial forum covers EU legal updates, root cause analysis, decentralised manufacturing, remote QP oversight, and more. A key event for senior QA and QP professionals. Learn more and view programme: https://www.qp-forum.org/conferences.html

Detailed Audit Readiness Tip

Focus Area: Material Receipt & Goods-In Inspection

Your incoming materials are the very foundation of every batch you produce. MHRA, FDA and EMA inspectors often start their facility tour in the Goods-In area because uncontrolled materials can lead directly to failed batches, contamination events or API mix-ups. It’s not enough to have a procedure, you must demonstrate that it’s followed consistently and that any deviations are caught and corrected in real time.

Here is a practical readiness checklist to focus on this week:

1. Master‐List Accuracy - Pull your current Approved Supplier List (ASL) and compare it against the red-letter vendor names on each receiving work order. Look for silent mismatches: e.g. “Acme API Co.” vs “Acme Active Ingredients Ltd.” Confirm that each received lot number, expiry date and certificate of analysis (CoA) matches the purchase order and CoA on file.

2. Physical Inspection Protocol – Observe a live receiving event. Are packages opened in a dedicated quarantine area? Check that visual inspections for damage, seal integrity, and correct labelling are performed and recorded on the goods-in log. Verify that any abnormal findings trigger an immediate quarantine tag and an electronic deviation entry.

3. CoA & Specification Verification – Select three recently received batches and review their CoAs end-to-end: supplier header, test results, revision date and signature. Ensure that CoAs are approved by QA before release and that any out-of-specification result has a documented investigation and CAPA.

4. Quarantine to Release Workflow – Trace one batch from receipt to final release: confirm that quarantine labels were removed only after full document and sample checks. Verify that held samples (e.g. retention, stability) are clearly identified, labelled with storage conditions, and accessible for future testing.

5. Communication & Escalation – Check the log of goods-in deviations for the last six weeks. Were suppliers, production planners and QA immediately notified of any holds or rejections? Confirm that follow-up actions (e.g. supplier corrective actions, expedited replacement orders) are documented, tracked and closed in your CAPA system.

Why this matters

Inspectors view the goods-in area as a barometer of your entire QMS or eQMS: inconsistent checks here often correlate with failures downstream in production or lab. Demonstrating a robust, end-to-end materials workflow not just a written procedure builds confidence that your site controls product integrity from the very first delivery.

Fun Pharma Fact

Did you know...? The world’s first pharmaceutical factory was built in Darmstadt, Germany, in 1827 by Emanuel Merck—founder of what is now Merck Group. This site marked the transition from traditional apothecary practices to industrial-scale medicine production.

The factory’s early products included morphine and codeine, both extracted from opium poppies using novel purification techniques for the time. It laid the groundwork for the standardisation and mass production of medicines we rely on today.

Modern pharma GMP facilities may use isolators, robotics, and AI-driven analytics—but they all trace back to that pioneering 19th-century site where Merck’s team made quality control part of the process long before regulations existed.

Closing Summary

That wraps up Edition #14 of GMP Compliance Corner.

This week, we spotlighted Adam’s guest appearance on the AssureBio QP Diaries podcast, recommitted to bringing back our long-form video content, and shared key global updates including new EMA guidelines, FDA drug approvals, and an in-depth recall case involving cefazolin mispackaging.

We also explored a critical audit readiness topic material receipt and goods-in inspection—plus flagged the newest NHS and QP training opportunities.

As always, thank you for reading, sharing, and building this community with us. If you’ve found something useful, pass it on to a colleague or team member.

See you next time and don’t forget to subscribe if you haven’t already:

Kyle Winn / Adam Walker

WinnPharma / @PharmaQP

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