Chemex offers fully validated methods to provide clients with superior confidence in reported data

A well defined and documented Chemex method validation process provides Clients and regulatory agencies with evidence that laboratory systems and methods are suitable for their intended use

What is Method Validation?
Method validation is the process of proving and documenting that a given analytical method, when correctly applied, produces results that are fit for purpose. No matter how well a method performs elsewhere, analysts need to confirm that the method is valid when applied in their laboratory.

Why Chemex performs analytical method validation?
Method Validation is required for the following reasons:
» Assuring quality and fitness for purpose of the method
» Achieving acceptance of products by the international agencies.
» Mandatory requirement purposes for accreditation as per ISO 17025 guidelines
» Mandatory requirement for registration of any pharmaceutical product or Pesticide formulation
» Validated methods are only acceptable for undertaking proficiency testing or inter-laboratory comparison studies.
 

What parameters are studied at Chemex for Method Validation?
For validation the developed method is subjected to following studies:
» Precision / Reproducibility
» Accuracy or Bias
» Method Detection Limits
» Quantitation Limits
» Specificity / Selectivity
» Linearity
» Robustness, Ruggedness

General Process of Validation of Methodology
At Chemex, the Method Validation Studies for the developed methods for various parameters are being regularly performed as per the following protocols and guide lines:
» EN 45 000 series of standards
» ISO / IEC Guide 25
» ISO / IEC 17025
»  EA MCERTS for soils and direct toxicity testing
» US EPA
» United States Pharmacopoeia
» Published Literature