When out-of-specification (OOS) laboratory results are explained rather than thoroughly investigated, and HPLC methods are not demonstrably fit for purpose, regulatory action may follow. A recent FDA Warning Letter highlights how recurring weaknesses in OOS handling and analytical method validation can result in significant CGMP compliance risks.
Eurachem has published a new Guide titled The Fitness for Intended Use of Analytical Equipment and Systems A Laboratory Guide to the Life Cycle of Analytical Equipment and Systems, their Qualification and Related Topics. The document addresses the entire life cycle and qualification of analytical equipment and systems used in laboratories, ranging from simple apparatus to complex computer-based systems, and promotes an integrated, risk-based approach to ensure fitness for intended use.
At the end of 2025, the Medical Device Coordination Group (MDCG) published the guideline 'MDCG 2025-10 Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices'. What does it contain?
Real-world evidence (RWE) is an approach that has gained importance in both the EU and the US in recent years. Real-world evidence helps when clinical trials cannot take into account the entire patient population with a particular disease. This concept is now to be expanded to include medical devices in the US. What is planned?
The subject line asks whether a change in the ownership of a pharmaceutical manufacturer could affect GMP compliance. According to the FDA, the answer is yes.
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has announced a major change of the European Pharmacopoeia (Ph. Eur.) publication schedule, starting with Issue 13.1.
In October 2025, the Data Integrity Task Force of the APIC Quality Group, which is a sector group of the European Chemical Industry Council (CEFIC), published version 3 of the document 'Data Integrity Frequently Asked Questions (FAQ)' on its website. In the new version, 'Chapter 5. Record life cycle management:' has been updated.
As can be seen from the quotations in FDA warning letters over the past three financial years, violations relating to the testing of raw materials and high-risk components are a recurring theme among GMP deficiencies at manufacturers of topical products and hand sanitisers. This led to the publication of two important FDA guidance documents two years ago.
In Pharmeuropa, the Comments concerning texts published in Issue 12.3 were published. These include explanations of the new, revised, and corrected texts adopted by the European Pharmacopoeia Commission, including Chapters 2.9.42 and 2.9.43 on dissolution testing.
The EMA has published a new Q&A addressing the requirement for Qualified Person (QP) certification of batches that are neither manufactured or physically imported in the EU/EEA market.