NEWS | ICH Q14 Guideline on analytical procedure development

This guideline describes science and risk-based approaches for developing and maintaining analytical procedures suitable for the evaluation of the quality of drug substances and drug products. It complements ICH Q2 Validation of Analytical Procedures.

This guideline describes science and risk-based approaches for developing and maintaining analytical procedures suitable for the evaluation of the quality of drug substances and drug products. It complements ICH Q2 Validation of Analytical Procedures.
March 22, 2024

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

For further information regarding regulatory procedures, you can send us an email at: [email protected]

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