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European GDP Association Developments May through August 2026

Find out what the European GDP Association was working on and accomplished in the second four months of 2026 - in the latest report.

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Warehouse Temperature Excursions: What Does the FDA Expect?

A recently published FDA Warning Letter makes clear that recurring excursions beyond specified storage conditions cannot be addressed simply by revising procedures and providing training. The FDA expects immediate corrective actions, a batch-specific assessment of potential quality impacts, and a systematic retrospective review of all available temperature data.

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Version 4.0 of the Swissmedic Document on Notifications of Changes Published

Swissmedic has published a new version of the document I-SMI.TI.22e, “Notifications according to Article 41, MPLO”, which addresses the major changes to facilities, equipment, systems and procedures that are subject to notification under Article 41 MPLO in the context of the manufacture, import and export, wholesale and distribution of medicinal products. The main practical change concerns the notification procedure.

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USA: Court Stops Warehouse Activities Following Persistent Insanitary Warehouse Conditions

The U.S. Food and Drug Administration (FDA) reports on a consent decree of permanent injunction against a warehouse operator and its owner. Under the court order, the company is prohibited from receiving, holding for sale, storing or distributing FDA-regulated products until further notice. The order was based on persistent insanitary conditions at a warehouse in Minneapolis.

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GDP Non-Compliance Report: CAPA Measures must not only be Promised but also Implemented

CAPA measures promised to the competent authority should be implemented effectively and within the specified timeframe. A recent GDP Non-Compliance Report from Latvia demonstrates the consequences of failing to do so: the wholesale distribution authorisation for veterinary medicinal products was suspended.

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FDA Warning Letter: Inadequate Warehouse Controls and Lot Traceability

A recent Warning Letter issued by the U.S. Food and Drug Administration (FDA) highlights how inadequate quality unit oversight, warehouse segregation and lot-level traceability can undermine the control of OTC drug products.

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Reminder: Submit your Presentation Proposal for the GDP Forum 2027 by 30 September

Last month, we published our call for presentations for the GDP programme of the GMP & GDP Forum 2027 in Berlin. Experts from industry, regulatory authorities and consultancy, as well as other professionals involved in GDP, can still submit a proposal on practical projects, lessons learnt and current topics such as artificial intelligence, modern quality systems and digitalisation. The deadline for submissions is 30 September 2026.

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GDP in the US: FDA Launches DSCSA Assessment for Small Dispensers and Issues Exemptions

The U.S. Food and Drug Administration (FDA) is encouraging small dispensers, defined as pharmacies with 25 or fewer full time employees, to complete a survey by 22 September 2026. In addition, the FDA is issuing exemptions from certain requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act for small dispensers and, where applicable, their trading partners until 27 November 2027.

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Q&A Version 22 on Safety Features for Medicinal Products

Version 22 of the Q&A on Safety features contains important clarifications regarding regulatory authorities’ access to Audit Trail data.

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GDP for APIs: APIC Publishes Updated "How to Do" Document

An updated version of the document “GDP for APIs: How to do” has been published on the APIC website. In addition to other revisions, the guide now also includes practical guidance on the good distribution practice of active substances used as starting materials in veterinary medicinal products.

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