december 5, 2024
Published by Joachim Nuyttens at december 5, 2024
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Deviations: Understanding OOS, OOT, and OOE in Pharmaceutical QC Laboratories

In the pharmaceutical and life sciences industries, product quality and patient safety are paramount. But what happens when processes don’t go according to plan? Managing deviations—unexpected events that diverge from approved standard operating procedures (SOPs), guidelines, or specifications—is crucial for maintaining compliance, quality, and safety throughout manufacturing, distribution, storage, and testing.  A deviation can occur when a parameter, measurement or analytical result exceeds a defined threshold, signalling a potential risk. Addressing these issues promptly and effectively is essential to prevent […]
december 2, 2024
Lab Technician evaluation environmental monitoring data
Published by Joachim Nuyttens at december 2, 2024
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Real-Time Environmental Monitoring: a Recent Innovation in Sterile Manufacturing

The pharmaceutical industry is undergoing a transformation, driven by the latest updates to GMP regulations like Eudralex Annex 1. This evolution demands more robust and efficient environmental monitoring solutions, particularly in the manufacturing of sterile medicinal products. One of the most promising advancements in this field is Real-Time Environmental Monitoring (RTEM), which provides continuous insights into air quality and contamination risks, ultimately enhancing compliance and operational efficiency.  The Need for Real-Time Monitoring  Traditionally, environmental monitoring (EM) has relied on growth-based methods, […]
augustus 31, 2021
richtlijnen
Published by Joachim Nuyttens at augustus 31, 2021
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Audit trail vereisten voor GxP computersystemen

Wikipedia definieert een audit trail als volgt: a chronological record providing documentary evidence of the sequence of activities that have affected at any time a specific operation, procedure, event, or device. Het eerste gebruik van audit trails dateert van de grote beschavingen uit de oudheid, wanneer eenvoudige methodes ontstonden om goederen, soldaten en financiële transacties op te volgen. Audit trails om data integriteit te borgen kregen in de farmaceutische industrie pas echt aandacht wanneer de US / FDA richtlijn 21CFR […]