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.
