Analytical Methods - USP's Future Expectations

Recommendation

26-28 October 2021

Bioassays and Bioanalytics + Stability Testing for Biological/Biotechnological Drug Substances and Drug Products - Live Online

The Pharmacopoeial Forum 39(5) contains an interesting article from the USP Validation and Verification experts group about USP's future requirements on the development and validation of analytical methods.

The article is entitled "Lifecycle Management of Analytical Procedures: Method Development, Procedure Performance Qualification, and Procedure Performance Verification".

In this article, the USP experts group discusses how the modern concept of a lifecycle model (according to the ICH guidelines Q8, Q9, and Q10) can be transferred to analytical procedures. The experts group suggests that the traditional approach to validation, transfer and verification should be integrated into the new "lifecycle process" for the analytical procedure.

Concretely, they propose that the requirements for the measurement of critical quality attributes should be established in the "Analytical Target Profile".

In alignment with the process validation approach, three stages are proposed:

• Procedure Design (development and understanding)
• Procedure Performance Qualification
• Continued Procedure Performance Qualification

The article also describes possible approaches for changes and the related activities. At the end of the article, a summary table presents the new "Lifecycle Approach" against the current approach and lists all the advantages of the new approach.

 You can find all information on the USP website of the Pharmacopeial Forum (PF).

PS: Dr Joachim Ermer - member of the USP experts group - will present USP's new approaches at the ECA Education Course HPLC in Analytical GMP Laboratories.

Source: USP