Method validation according to ANVISA

You wish to validate your analytical methods according to ANVISA?

To begin with, what is a method validation?

Analytical method validation is the process that takes place after the development of a method. This step verifies the method and ensures that it meets expectations by respecting the targeted standards.

The validation of method puts to the test various parameters of analyses in particular:

  • accuracy
  • linearity
  • limit of detection
  • fidelity
  • repeatability
  • the stability…

What is ANVISA?

First of all, ANVISA stands for “Agência Nacional de Vigilância Sanitária”. It is the Brazilian health regulatory agency. As such, it is part of the Brazilian national health network and coordinates the different health-related regulations.

Thus, it executes the control of processes, ingredients, production and commercialization of any product that has an impact on health.

Therefore, the validation of your analytical methods according to ANVISA allows you to sell your products in Latin America and to ensure the quality of your products to the competent authorities.

FILAB supports you in the validation of your analytical methods according to ANVISA

For more than 20 years, our laboratory FILAB has had the experience and the specific analytical equipment to assist companies in the validation of analytical methods according to ANVISA.

FILAB also provides method validation services according to various regulations and standards such as

  • Method validation according to ICH Q2

  • Method validation according to USP 1225

  • Method validation according to SANCO 30/30

  • Method validation according to EP 2.4.20

  • Method validation according to NF T 90-210

FILAB also provides ANVISA remote method validation management services and ANVISA method validation training for your teams.

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

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