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: info@asphalion.com

Search News & Events

  • Filter by category

Share

Related news and events

HORIZON | siNPAIN meeting in Reykjavík

The objective of this project is to create a siRNA-combined advanced therapy, which will allow a more personalised treatment for different stages of osteoarthritis.  All siNPAIN partners are working hard to develop efficient therapy to improve the quality of life of those affected by osteoarthritis, a chronic joint condition that affects more and more people every year.

For further information

If you are interested in our services, or wish to get in touch for a general enquiry, please contact us for more information.

Fill the form and we will contact you as soon as possible.

You can also follow us on:

Schedule a Free Meeting

Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts. 

We will be happy to assist you!

Schedule a meeting