Validation of laboratory analysis methods according to the ICH Q2 standard
Your needs: analyse the composition of your products using a validated analysis method based on the international ICH Q2 standard
Why validate an analysis method according to the ICH Q2 standard?
The ICH Q2 international guideline concerns the procedures to be followed for the validation of methods of analysis. It has been developed by an ICH Expert Group and has been subject to consultation by regulatory bodies in accordance with the ICH process.
The revision of ICH Q2 (R1) includes principles for the validation of methods of analysis covering the analytical use of spectroscopic or spectrometric data (e.g. analytical techniques such as FTIR, Raman, NMR or MS), some of which often require multivariate statistical analysis.
Our solutions: provide you with our expertise in validating analytical methods in accordance with the ICH Q2 guideline.
Our laboratory analysis services
For more than 30 years, our FILAB laboratory has had the experience and specific analytical equipment to support companies in the medical and pharmaceutical sectors in validating analytical methods in accordance with ICH Q2, in particular for the following parameters:
Whatever the analytical method, here are the main criteria to consider when validating an analytical method:
- specificity (or selectivity)
- precision: repeatability, intermediate precision, reproducibility
- accuracy
- linearity
- sensitivity (Limit of Detection (LoD) and Limit of Quantification (LoQ))
- stability
- robustness
- measurement uncertainty
From the development of the analytical method to routine analysis, the FILAB laboratory offers a complete range of analytical services in compliance with the ICH Q2 guideline:
- Validation of analytical methods
- ICH Q3C residual solvent analysis
- Analysis of elemental impurities ICH Q3D
- Analysis of HCT/COT cleaning residues
- Ethylene oxide analysis
- Custom chemical analysis
- Analytical development
Why FILAB ?
As an independent laboratory with a team of experienced doctors and engineers, FILAB guarantees the reliability of its results, rapid response to requests and personalised support for its customers.
How can you contact us?
If you would like to call on our experts for a thermal analysis, request your free quote online here.
For more information about our analysis services, contact us at contact@filab.fr or call +33 (0)3 80 52 32 05.
The positive aspects of FILAB
A highly qualified team
Responsiveness in responding to and processing requests
A complete analytical park of 2100m²
Tailor-made support
