EMA publishes ICH Q14 Guideline on Analytical Procedure Development - Step 5

As already reported, the ICH Q2(R2) Revised Guideline on "Validation of Analytical Procedures” and the new ICH Q14 Guideline on “Analytical Procedure Development” were made available for download on the ICH website shortly before Christmas 2023.

On 26 January 2024, the European Medicines Agency (EMA) has now published the new ICH Q14 as Step 5. The date for coming into effect is 14 June 2024.

The "guideline describes science and risk-based approaches for developing and maintaining analytical procedures suitable for the assessment of the quality of drug substances and drug products. It applies to new or revised analytical procedures used for release and stability testing of commercial drug substances and products (chemical and biological/biotechnological). The guideline can also be applied to other analytical procedures used as part of the control strategy following a risk-based approach."

To download the document and to see the document history, please visit the EMA website.

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