1 / 4

What Are The Fundamental Rules For Validating A Method

The bioanalytical method validation of an analytical procedure is a technical process established by laboratory sciences. It is necessary to confirm through the analytical method transfer that the product displays verifiable accuracy, is sensitive, specific, is easily reproduced, and is suitable for human use.

Download Presentation

What Are The Fundamental Rules For Validating A Method

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript


  1. WHAT ARE THE FUNDAMENTAL RULES FOR VALIDATING A METHOD?

  2. The bioanalytical method validation of an analytical procedure is a technical process established by laboratory sciences. It gauges whether the performance characteristics of the product meet the requirements of its intended use. There are various reasons for carrying out method validation, for example, regulatory requirements, quality control, and compliance. It is required to confirm that the product has verifiable accuracy, is sensitive and specific, is easily reproducible, and is acceptable for human use through the analytical technique

  3. The most common procedure followed in method validation is the following: • Planning and agreeing on method validation experiments • Writing and approving the method validation protocol • Performing the method validation protocol • Analyzing the method validation data • Reporting the analytical method validation After the method validation process is complete, all of the data should be analyzed to provide a comprehensive report that includes a definite assertion of success or failure. To maintain a consistent and steady process, the data collected during the technique must be evaluated as quickly as feasible. Read more Reference link visit here: https://www.fuzia.com/article_detail/160749/what-are-the-basic-principles-of- method-validation

  4. Company: NorthEast BioLab Contact us: +1 203-361-3780 Email_Id: info@nebiolab.com Address: 925 Sherman Avenue, Hamden, CT, USA 06514 Website: https://www.nebiolab.com/

More Related