Analytical method verification according to USP 1226
Pharmaceutical companies wishing to verify their analytical methods in accordance with USP 1226
What is method verification?
Analytical method verification is a crucial process in laboratories and regulated industries, such as pharmaceuticals, biotechnology and chemistry. In these fields it is essential to ensure that the methods used to analyze samples are reliable, accurate and appropriate for the specific use. Method verification is particularly important when a laboratory adopts an analytical method already validated elsewhere, or when there are changes in test conditions.
What is the purpose of a method verification ?
The aim of USP 1226 method verification for pharmaceutical manufacturers is to confirm that methods are well adapted to the specific laboratory environment, comply with strict regulatory standards and deliver high-quality results.
What does USP 1226 say?
USP 1226 guides laboratories on how to demonstrate that the performance of an established and validated analytical method can be reproduced in their specific environment. The main objectives are to ensure that the method is: 1/ Fit for purpose, 2/ Reliable, 3/ Conforms to the original validation criteria.
What are the steps involved in USP1226 method verification ?
The method verification process follows methodical steps, starting with a review of the original documentation to understand the method’s capabilities and limitations. Secondly, a detailed plan is drawn up to define the parameters to be tested and how the tests will be carried out. Thirdly, a series of experiments is carried out for each parameter. Finally, the data collected is analyzed to evaluate the method’s performance.
FILAB can help you validate your methods in accordance with USP 1226
Why call on FILAB for USP 1226 method validation ?
For over 30 years, our FILAB laboratory has had the experience and specific analytical equipment to support companies in validating analytical methods in accordance with USP 1226.
FILAB also performs method validations in accordance with various regulations and standards, in particular :
VALIDATION STANDARDS / METHOD VERIFICATION at FILAB
FILAB can also support you in piloting remote method validation according to USP 1226, and in training your teams in method validation according to USP 1226.
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
