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Regulators hit Italian drugmaker with warning over manufacturing issues

Pills in blisters

Regulators hit ICI International Chemical Industry for failing to comply with good manufacturing practices at its Cellole, Italy plant. (Shutterstock)

Italian regulators slapped a warning letter on ICI International Chemical Industry for failing to comply with good manufacturing practices at its Cellole, Italy plant.

The Italian Medicines Agency found in a March 22 inspection of the facility that there were 19 major and nine other deficiencies related to “inadequate pharmaceutical quality systems that resulted in a number of issues.”

Those issues included poor deviations management and investigation, lack of documentation handling, lack of cleaning validation, lack of process validation, as well as a lack of analytical review and method validation and poor computer system validation.

Italian regulators slapped a warning letter on ICI International Chemical Industry for failing to comply with good manufacturing practices at its Cellole, Italy plant.

The Italian Medicines Agency found in a March 22 inspection of the facility that there were 19 major and nine other deficiencies related to “inadequate pharmaceutical quality systems that resulted in a number of issues.”

Those issues included poor deviations management and investigation, lack of documentation handling, lack of cleaning validation, lack of process validation, as well as a lack of analytical review and method validation and poor computer system validation.

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