ICH Q3E, Recalls & NHS Aseptic Services | Edition 28

Introduction

Over the last few weeks, we have been shifting how we share content across Help Me GMP. Alongside the newsletter and long-form YouTube videos, we have restarted our GMP Shorts series and are expanding our presence across short-form platforms, including TikTok (https://www.tiktok.com/@helpmegmp) and Instagram (https://www.instagram.com/helpmegmp/) .

This is not about chasing trends. It is about meeting people where they are already consuming information, and delivering clear, accurate GMP messages in formats that fit into busy working days. Short-form content allows us to reinforce fundamentals, highlight common inspection pitfalls, and prompt better questions, without replacing the depth needed for proper understanding.

The newsletter remains the anchor. It is where we slow things down, provide context, link back to regulators and standards, and connect individual topics into a wider GMP system. The different formats are designed to work together, not compete.

From the Help Me GMP Shorts Series

Over the past week, the following GMP Shorts have gone live:

What Inspectors Assess First | GMP Inspection Basics This short focuses on the immediate visual and behavioural indicators inspectors use to form early confidence in a site, including housekeeping, gowning discipline, material status control, and documentation behaviour before formal record review begins.

Internal Audits Are Not Optional | GMP Basics This short reinforces that internal audits are a regulatory requirement under GMP, not a discretionary activity. It highlights the expectation for risk-based planning, objective execution, documentation, and effective follow-up through investigation and CAPA.

Inspection Ready Explained | GMP Basics This short clarifies what “inspection readiness” actually means in practice, emphasising that it is a continuous operating state supported by current SOPs, accurate documentation, trained personnel, and ongoing oversight, rather than a last-minute preparation exercise.

News in Pharma (Last 14 Days)

MHRA consultation open on ICH Q3E Extractables and Leachables

The MHRA has opened a UK consultation on the adoption of ICH Q3E, covering extractables and leachables. This guidance has direct implications for container closure systems, single-use systems, filters, tubing, and medical device combination products. Quality and manufacturing teams should be considering how material selection, supplier qualification, and change control processes will need to adapt. https://www.gov.uk/government/consultations/consultation-on-the-international-council-for-harmonisation-guideline-q3e-for-extractables-and-leachables

EMA revised variations framework now live

The revised EU variations framework has now gone live, changing how marketing authorisation variations are categorised and submitted. This has knock-on effects for quality change management, regulatory strategy, and timelines for implementation of manufacturing and control changes. https://www.hma.eu/human-medicines/cmdh/procedural-guidance/variation.html

Continued regulatory focus on contamination control strategies

Regulatory agencies continue to reinforce expectations around holistic contamination control strategies, particularly for aseptic and sterile operations. While not a single new publication, recent inspections and guidance updates consistently reference the need for documented, site-specific CCSs that are actively used and reviewed, not static documents. This remains a key inspection risk area for 2026.

Recalls and Quality Defects

Licensed medicines only | UK, EU, USA | Regulator-anchored

EU (Ireland – HPRA)

Palmeux prolonged-release suspension for injection (multiple strengths) Action: Recall of all batches Authority: HPRA

The HPRA issued a recall of all batches following GMP deficiencies identified at the manufacturing site. The recall was precautionary and highlights how upstream GMP failures can rapidly translate into market action, even in the absence of confirmed patient harm. https://www.hpra.ie/safety-information/safety-notices

USA (FDA)

Certain drug products distributed by Gold Star Distribution, Inc. Action: Recall due to insanitary distribution conditions Authority: FDA

This recall followed FDA inspection findings at a distribution facility, including pest contamination. It reinforces that GMP responsibility extends beyond manufacturing, and that GDP failures can render otherwise compliant products unsuitable for use. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/gold-star-distribution-inc-issues-recall-certain-fda-regulated-products-three-states-including-drugs

UK (MHRA)

Prednisolone 5 mg Soluble Tablets Action: Class 3 Medicines Recall

The MHRA issued a Class 3 recall due to swollen blister pockets, which may affect product integrity over time. Although patient harm is considered unlikely, the product does not meet full quality specifications. https://www.gov.uk/drug-device-alerts

UK (MHRA)

Clarithromycin 500 mg powder for concentrate for solution for infusion Action: Class 2 Medicines Recall

This Class 2 recall was issued following GMP concerns linked to supplier certification, requiring quarantine and return of affected batches. https://www.gov.uk/drug-device-alerts

Upcoming Conferences and Training

Making Pharmaceuticals and Distributing Pharmaceuticals 2026

Date: 21–22 April 2026 Location: Coventry, UK

A UK-focused event covering pharmaceutical manufacturing, quality, supply chain, and regulatory topics. https://www.makingpharma.com/

Making Pharmaceuticals

NHS Aseptic Services Update

iQAAPS submissions remain a live assurance requirement

All NHS aseptic preparation services must continue submitting monthly Quality Indicator data via iQAAPS. SPS QA teams actively review submissions to inform risk-based audit planning and escalation. Missing, late, or unexplained data remains a common trigger for increased scrutiny. https://www.sps.nhs.uk/articles/submitting-iqaaps-quality-indicators-qis/

QAAPS Edition 5 remains the applicable standard

QAAPS Edition 5 continues to underpin NHS aseptic audits alongside EU GMP Annex 1. Services should not assume new requirements until a formally published update is issued and adopted. https://www.rpharms.com/recognition/setting-professional-standards/quality-assurance-of-aseptic-preparation-services

Audit Readiness Tip

Short-Form Content, Long-Form Evidence

As more GMP education moves into short-form formats, inspectors are increasingly alert to a mismatch between what staff can say and what systems can evidence.

A common inspection weakness is staff confidently describing expectations, but being unable to show how those expectations are embedded in procedures, training records, and quality oversight.

Before your next inspection, ask yourself:

Can staff explain why a control exists, not just what it is?

Can you show how short-form training or awareness content links back to controlled SOPs and training records?

Is there evidence that learning is assessed, not just consumed?

Short-form learning is powerful, but it must always sit within a documented, controlled quality system.

Fun GMP Fact

The term “objectionable microorganism” has no fixed list in GMP. Whether an organism is objectionable depends on product type, route of administration, patient population, and manufacturing controls, not just its name.

Call to Action

If this newsletter is useful, please share it with a colleague. You can also subscribe to the Help Me GMP YouTube channel for free, practical GMP education across long-form and short-form formats.

Our aim remains the same: clear, inspection-ready GMP education that helps you do your job with confidence.

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