Method validation according to USP 1225

Industriels du secteur pharmaceutique, vous souhaitez valider vos méthodes analytiques selon l'USP 1225

Qu'est-ce qu'une validation de méthode ?

The method validation process takes place after the development of the method. This step allows to verify the method and to make sure that it meets the expectations by respecting the targeted standards.

The validation of method evaluates various parameters in particular:

  • linearity
  • accuracy
  • fidelity
  • repeatability
  • detection limits
  • stability…

In addition, USP 1225 is a standard that concerns the validation methods of analytical procedures applied to drugs and biological products. Thus, in order to validate your analytical methods according to the USP 1225 standard, the support of a specialized laboratory is essential. 

FILAB laboratory supports you in method validation according to USP 1225

For more than 30 years, our FILAB laboratory has had the experience and specific analytical equipment to assist companies in the validation of analytical methods according to USP 1225.

In addition, FILAB also performs method validation according to various regulations and standards, including

  • Method validation according to ICH Q2

  • Method validation according to PE 2.4.20

  • Residual solvent analysis ICH Q3C

  • Method validation according to SANCO 30/30

  • Elemental impurity analysis ICH Q3D

  • Method validation according to NF T90-210

  • Method validation according to ANVISA

FILAB can also provide you with remote method validation services according to USP 255, as well as training for your teams in method validation according to USP 255.

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

Benoît PERSIN Sales Manager
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