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In March 2026, the Croatian medicines agency HALMED inspected two manufacturing sites of an Indian sterile products manufacturer on behalf of the EU and identified serious GMP deficiencies, which are now available in the EudraGMDP database.

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What is a 'Contamination Control Strategy', where is it required, who does it affect, and how can a CCS be established within a company? This brief summary provides information on requirements, content, regulatory background and practical approaches.

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The FDA inspected the Indian manufacturer of sterile OTC products in December 2025. Serious deficiencies included the absence of a protective barrier in Area A, the inadequate aseptic design of the production line and violations of data integrity. A Warning Letter has now been issued.

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The U.S. Food and Drug Administration (FDA) has recently published several Warning Letters and Untitled Letters to OTC drug manufacturers, highlighting deficiencies in asbestos risk control for talc-containing products. FDA cites insufficient testing programs and inadequate monitoring to ensure talc is appropriately verified for quality and the absence of asbestos.

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A Contamination Control Strategy (CCS) in a company covers many areas. Some aspects, such as the classical topics from Annex 1, are quickly recognized as part of a CCS. However, other areas are also affected that do not immediately stand out when one looks only at the chapter headings of Annex 1. One such topic that we would like to briefly touch on today is the outsourcing of activities related to cleaning and disinfection.

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The FDA is currently revising its guidance on pre-approval inspections (PAI). The amendments mainly concern the introduction of a risk-based approach to inspection planning and the use of alternative methods.

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Contamination control measures also play an important role in the case of non-sterile medicines. A new Q&A from the EMA answers questions on this topic.

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The European QP Association (EQPA) is committed to providing practical tools for Qualified Persons (QPs) to support them in their day-to-day responsibilities. One such tool is QPSHARE, which all members can access free of charge to foster audit collaboration.

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The FDA inspected the site of a Japanese pharmaceutical manufacturer in Tokyo in November 2025 and found, amongst other things, fundamental deficiencies in the aseptic manufacturing processes. Due to the severity of the violations, a Warning Letter has now been issued.

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Almost every week, the US FDA publishes Warning Letters in which it criticises companies for inadequate CAPA measures and insufficient Quality Oversight. Now two sites in the EU have been affected

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