Regulatory Updates & Compliance
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GDP 2025: The Overlooked Warehouse Rule That’s Causing 80% of Audit Failures
read more >>: GDP 2025: The Overlooked Warehouse Rule That’s Causing 80% of Audit FailuresA silent crisis is unfolding in pharma logistics: 80% of recent Good Distribution Practice (GDP) audit failures trace back to one overlooked 2025 update—and most warehouses are dangerously unprepared. The culprit? EU GDP 2025’s new Chapter 9.2, which mandates:🔴 Real-time temperature monitoring (no more data loggers alone)🔴 Blockchain-based custody trails for high-risk shipments🔴 Automated deviation…
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Global Serialization Countdown: Which Countries Are Enforcing Laws in 2025?
read more >>: Global Serialization Countdown: Which Countries Are Enforcing Laws in 2025?The world is entering the most aggressive phase of pharmaceutical serialization enforcement yet. By December 2025, 87% of global drug markets will have active serialization laws—and non-compliant companies face product seizures, steep fines, and even criminal penalties. This isn’t just about barcodes anymore. 2025 marks the tipping point where serialization becomes the universal language of…
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FDA’s 2025 Crackdown: 5 New Rules That Could Shut Down Non-Compliant Distributors
read more >>: FDA’s 2025 Crackdown: 5 New Rules That Could Shut Down Non-Compliant DistributorsThe Coming Storm in Pharma Distribution The FDA is preparing its most aggressive regulatory overhaul in a decade, with five new rules set to take effect in 2025 that could put non-compliant distributors out of business. These changes represent a fundamental shift from voluntary guidance to mandatory enforcement – and the clock is ticking for…