ANALYTICAL METHOD DEVELOPMENT

What are the capabilities of ITL Labs in method development ? ITL Labs has the trained expertise and all the state-of-the-art-facilities required for developing new methods of analysis for all kinds of components in different complex matrices. The methods developed by ITL Labs can be used by other laboratories. The capability of ITL Labs in this area has been acknowledged by the international bodies concerned with the quality standards and systems.

Method Validation / Evaluation

Method validation is the process of documenting or proving that : Analytical Method provides analytical data for the intended use

Method Validation / Evaluation

Method validation is the process of documenting or proving that Analytical Method provides analytical data for the intended use

Why is analytical method validation required ?

Method Validation is required for the following reasons:

Assuring quality and achieving 3 a levels
Achieving acceptance of products by the international agencies.
Mandatory requirement purposes for accreditation as per FDA , ISO 9001 & 17025 guidelines
Mandatory requirement for registration of any pharmaceutical product or Pesticide formulation
Validated methods are only acceptable for undertaking proficiency testing.

What are the various parameters studied for Method Validation ?

For validation the developed method is subjected to following studies :

Precision / Reproducibility
Accuracy
Linearity
Specificity / Selectivity
Limit of detection
Limit of quantitation
Robustness / Ruggedness