Analytical method verification according to USP 1226
As a pharmaceutical manufacturer, you want to check your 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 audit ?
The aim of USP 1226 method verification for the pharmaceutical industry 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 the USP 1226 standard 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 required for 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 according to various regulations and standards, including :
VALIDATION STANDARDS / METHOD VERIFICATION at FILAB
Method validation according to SANCO 30/30
Furthermore, FILAB also supports you in remote method validation management services according to USP 1226, and in training your teams in method validation according to USP 1226.
FAQ
Method verification is necessary in several circumstances:
- When the method is adopted for the first time in a laboratory
- When the sample matrix differs from that described in the pharmacopoeia
- When the equipment used for analysis differs from that recommended by the USP
The objective is to confirm that the compendial method works correctly under the specific laboratory conditions, with the product to be analyzed. This ensures the reliability of the results without having to completely revalidate the method.
Yes, any pharmacopoeial method used for quality control must be verified beforehand as part of routine use. However, the scope of the verification depends on the associated risk and any deviations from the original method (e.g., changes in matrix, equipment, etc.).
All compendial methods: analysis of raw materials, finished products, impurities, dissolution, identification, dosage
