ICH Guidelines on particle properties
WHITE PAPER | Particle Analytical ApS
JANUARY 31, 2017
This White Paper from Particle Analytical explores how International Conference on Harmonization (ICH) Guidelines apply to control of particle properties and how they should be interpreted.
This short paper provides an overview of the relevant ICH guidelines, including requirements in relations to product stability (ICH Q1A-Q1F) and for analytical validations (ICH Q2) used to control the product. Furthermore, ICH Q8(R2) on Pharmaceutical Development is mentioned, where requirement for testing of physical properties, such as solubility, water content, particle size, crystal properties, biological activity and permeability.
The paper further discusses how to interpret ICH Q6A (Specifications), covering, for instance particle size, which has a “significant effect on dissolution rates, bioavailability, and/or stability”. Here the paper outlines a risk analysis ad testing methodology that ensures the developer remains in control of the process.
Finally, discussing ICH Q9 (Quality Risk Management), the paper sums up a focused approach to risk evaluation that will make it more straightforward and cost-effective to define which parameters should be under evaluation and control.
The paper also guides readers to specific aspects where Particle Analytical can provide specific solutions for navigating ICH requirements.