Validation services for analytical methods in a laboratory

Why is it important to have an analytical method validated ?

Whatever your field, validation of an analytical method allows you to ensure the reliability and the tractility of results from a lab analysis on any given matrix.  

What are the factors to take into account during the validation process ? 

These are the main criteria to consider while validating an analytical method :

  1. Specificity (or selectivity)
  2. Reliability
    1. Repeatability
    2. Intermediate reliability
    3. Reproducibility
  3. Accuracy
  4. Linearity
  5. Sensitivity
  6. Detection limit (LoD) quantification limit (LoQ)
  7. Stability
  8. Robustness
  9. Uncertainty of the measurement

 

What are the preexisting regulations surrounding the validation of analytical methods ?   

Many available standards cover the validation of analytical methods and approval criteria, such as:

  • ISO 17025:2005 : General requirements for the competence of testing and calibration laboratories
  • ISO 5725-1:1994 : Accuracy (trueness and precision) of measurement methods and results
    • Part 1: General principles and definitions
    • Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method
  • FDA Guidance for Industry (July 2015): Analytical Procedures and Methods Validation for Drugs and Biologics
  • ICH Q2 (R1) : Validation of analytical methods : text and methodology
  • NF T90-210 May 2009 : water quality - protocol for the initial method performance assessment in a laboratory
  • NF V03-110 May 2010 : Analysis of foodstuffs - Protocol of characterization for the validation of a quantitative method of analysis by construction of an accuracy profile
  • Citac / Eurachem Guide: Quality control in Analytical Chemistry
  • Analytical validation guide : SFSTP commission report  – I methodology

FILAB can assist you in validating your analytical methods

For over ten years, FILAB has been building up extensive experience in validating new analytical methods, whatever the techniques involved : GC-MS, HPLC-MSMS, ICP-MS, ICP-AES…

Today we can provide custom validation services or we can assist you in setting up a validation study or help with processing statistics.

The FILAB laboratory also provides other similar analytical services, all with high added value :

  • Analytical development
  • Custom chemical analyses
  • Elemental analysis
  • Impurity analysis
  • Material characterization
  • Heavy metal analysis 

 

For more information, feel free to contact us via email at contact@filab.fr or over the phone by calling +33 (0)3 80 52 32 05

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