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UK’s MHRA Enhances Risk-Based Inspection Process

 
• By Bowman Cox

MHRA has begun sifting data with powerful software to help the British inspectorate set GMP inspection priorities – and even to alert companies to emerging issues so they can take steps to stay out of trouble. Other agencies show interest in using the system, which would enable data sharing that could make it even more sensitive and confident in its risk analysis.

Using sophisticated software algorithms, the United Kingdom’s regulatory authority looks to become increasingly prescient when planning inspections of pharmaceutical manufacturing plants.

The more risk data it’s fed, the more predictive the software becomes, which has led the UK’s Medicines Healthcare products...

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More from Europe

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