GMP News

FDA Blockchain Pilot

The US FDA has selected four companies to participate in a pilot evaluating blockchain technology to enhance supply chain security.


Hard Brexit: MHRA Preparations

The Biritsh Medicines and Healthcare products Regulatory Agency (MHRA) has published several guidelines for a possible no-deal scenario.


Warning Letter due to GMP Deficiencies in Tableting

An Indian manufacturer of solid dosage forms recently received a Warning Letter from the US FDA after the authority had revealed serious deficiencies in the tablet production.


Ongoing severe Quality Deficiencies lead to regulatory Action - Part 1

The second Warning Letter within six months reveals fundamental issues in quality management. Learn more about the new FDA warning letter to US company Akorn.


Comprehensive FDA Warning Letter Analysis - Stability Testing on the Rise

Over and over again, FDA inspectors discover violations of long-established GMP requirements. Read more about which trends in the areas of quality control and production can be identified from the analysis of the Warning Letters issued in the last 21 months.


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