The European Medicines Agency recently published a Guideline that applies to analytical procedures used for release and stability testing of commercial drug substances and products.
The Guideline also describes the principles to support change management of analytical procedures based on risk management, comprehensive understanding of the analytical procedure and adherence to predefined criteria for performance characteristics. Knowledge gained from application of an enhanced approach to analytical procedure development can provide better assurance of the performance of the procedure, can serve as a basis for the analytical procedure control strategy and can provide an opportunity for more efficient regulatory approaches to related post approval changes.
The Guideline will come into effect on 14 June 2024.
Have a look at the complete document here: ICH Q14 Guideline on analytical procedure development
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