GMP Compliance Corner Edition 17

This week, we’re excited to introduce you to the newest member of the Help Me GMP team. To help us bring you even more engaging content and to free up time behind the scenes for editing, writing, and building new ideas we’re welcoming Charlie, who will take on the role of on-camera presenter across our Shorts, long-form videos, and platform updates.

WinnPharma

7/28/20255 min read

Edition 17

This week, we’re excited to introduce you to the newest member of the Help Me GMP team.

To help us bring you even more engaging content and to free up time behind the scenes for editing, writing, and building new ideas we’re welcoming Charlie, who will take on the role of on-camera presenter across our Shorts, long-form videos, and platform updates.

Charlie will help bring our scripts to life, so Adam Walker and Kyle Winn can focus on the newsletter, content planning, eBook development, and a few other exciting projects we’re cooking up in the background.

It’s been a big few weeks, and we’re grateful for your continued support across YouTube, TikTok, and our growing LinkedIn community.

Let’s dive into what’s new this week…What’s New: Community Growth & Our First eBook

It’s been a huge week for the Help Me GMP community and we couldn’t be more grateful.

In just 7 days, over 300 professionals have joined our brand-new LinkedIn community group, a dedicated space to ask questions, share insights, and build confidence in all things GMP, QA, QC, and production. The discussions so far have been incredibly thoughtful and supportive, if you haven’t joined yet, we’d love to see you there: ➡️ https://www.linkedin.com/groups/10173020/

We’ve also quietly released our first-ever Help Me GMP eBook: “What is GMP?” a free, downloadable resource based on one of our most popular videos, now available in accessible format for teams and learners at every level. If you haven’t grabbed your copy yet, check the pinned post on our company page to get it first.

We’re just getting started and we’re already working on the next titles in the series.

Regulatory Updates (13 – 20 July 2025)

MHRA (UK)

  • Mirvetuximab soravtansine (Elahere) approved for platinum-resistant ovarian cancer – 24 July 2025. First UK authorisation for a folate-receptor-α–targeted ADC, indicated after one to three prior lines of therapy. Prescribers must enrol patients in a post-authorisation safety study to monitor ocular events. https://firstwordpharma.com/story/5983687

  • Class 2 medicines recall – Flutiform 250 µg/10 µg pressurised inhaler – Drug-alert EL(25)A/35 issued 24 July 2025. Carton over-states delivered dose, risking under-treatment. Pharmacies/wholesalers must quarantine and return affected lots. https://firstwordpharma.com/story/5983768

EMA (EU)

FDA (USA)

News from Pharma (13 – 20 July 2025)

These developments underline an active week of M&A, manufacturing expansion, regulatory setbacks, and novel patient-access models — all worth flagging in your competitive-intelligence dashboard.

Recalls in Pharma (15 – 22 July 2025)

MHRA – United Kingdom

Flutiform 250 µg / 10 µg pressurised inhaler – Batch GF2303 Class 2 Medicines Recall • Drug Alert EL (25)A/35 – issued 24 July 2025

FDA – United States

No new prescription-drug recalls were posted by FDA between 15 and 22 July 2025.

EMA / EU

No centrally issued medicine recalls were published in the same period.

NHS Aseptics & SPS Updates (15 – 22 July 2025)

Temperature-Controlled Storage of Medicines – FINAL REMINDER Live WebEx • 25 July 2025, 13:00–14:00 BST Register ⇒ https://www.sps.nhs.uk/articles/temperature-controlled-storage-of-medicines/

Call for Contributors – Next QAAP Standards (closes 31 July 2025) Shape the future national standard for QA of Aseptic Preparation Services. Apply ⇒ https://www.rpharms.com/about-us/news/details/call-for-expressions-of-interest-to-develop-the-next-qaaps-guidance

New SPS Guidance – “Why Temperature Management Matters for Medicines Storage” Updated 25 July 2025; provides practical steps to prevent excursions in ward, pharmacy and transport settings. Read ⇒ https://www.sps.nhs.uk/articles/understanding-why-temperature-management-is-important-for-medicines-storage/

Detailed Audit Readiness Tip

Focus Area: Batch Record Review, From Completion to QA Sign-Off

Batch records are one of the first documents reviewed by regulators and the root cause of many critical findings during MHRA and FDA inspections. Yet even well-run sites can fall short when it comes to timeliness, traceability, and completeness.

This week’s focus is on ensuring your batch record process stands up to scrutiny, from the moment of completion on the floor to final QA sign-off.

Readiness Checklist:

  • Clear Documentation of All Stages Ensure each processing step, in-process check, and cleaning entry is initialled, dated, and completed in real time. No “catch-up” entries.

  • Error Handling Is Legible and Justified Crossed-out entries must be clearly corrected with signature, date, and reason. If data has been rewritten, both the original and corrected values should be traceable.

  • Reconciliation Sections Fully Completed Check that product/component reconciliation includes actual usage, wastage reason, and final yield, with supervisor and QA sign-off. Missing yield calculations are a common weakness.

  • QC Sample Handling Is Documented Include exact details of what was sampled, where samples were taken, how they were labelled, and where they were stored. This should match the sampling SOP exactly.

  • Batch Record Review Logs Are Up to Date Review logs showing QA review dates and reviewer names for each batch should be maintained. Delays in review must be justified and tracked.

Why This Matters:

Regulators expect to see a living, accurate reflection of manufacturing activity, not paperwork recreated at the desk. Any mismatch between what happened on the floor and what’s recorded in the batch file risks serious data integrity findings especially if records look “too perfect.”

Fun Pharma Fact

The First GMP Guidelines Were Only 3 Pages Long

When the very first version of Good Manufacturing Practice was introduced by the U.S. FDA in 1963, it was just three pages long. At the time, the guidance focused almost entirely on cleanliness and the prevention of cross-contamination in penicillin manufacturing a major issue following fatal allergic reactions caused by poorly cleaned equipment.

Today, GMP expectations span hundreds of pages across the FDA, EU, MHRA, WHO, and PIC/S frameworks but the core principles haven’t changed: put the patient first, follow your process, and document what you do.

Summary & Close

In this edition, we welcomed Charlie, the newest member of the Help Me GMP team, who’ll be fronting our videos and content to help bring GMP topics to life so Adam and I can keep focusing on editing, writing, and building new resources behind the scenes.

We also celebrated the launch of our first free eBook, continued growing our GMP LinkedIn community (now over 300 members in just a week!), and delivered another packed issue full of the latest recalls, inspections, training resources, and audit tips.

If you haven’t already, subscribe to the newsletter and check out our newest content on YouTube and TikTok. We’re just getting started.

Stay sharp, stay compliant and thank you for being part of the journey.

Kyle Winn WinnPharma

Adam Walker @PharmaQP