DP Method transfer and verification

[Alaaelkazak]

Dear forum members,
I am asking about the teast that should be perfomed for a validated NDSRI method transfer from one lab to another for the drug product. What should be the test and acceptance [aramters in htis case.
The same applies for publushed methods either by authirites or in scineitfic journals, what should be the method verfication tests and paramaters?
@Yosukemino @lucas10mauriz @Naiffer_Host any help?

[Naiffer_Host]

I believe you will find this post handy. Publications and recent FDA presentations mentioned this…

Nitrosamines: Mass Spectrometry-Based Analytical Procedures

Are you facing significant challenges in your analytical methodology for quantifying nitrosamines? A collaborative effort involving various regulatory bodies occurred, including: US FDA, Health Canada, ANSM (France), Swissmedic (Switzerland), LGL (Germany), and TGA Laboratories (Australia). This partnership aimed to investigate the consistency of nitrosamine measurements. Each lab contributed its unique analytical methods to assess nitrosamine levels in standardized samples. In the paper title…

[lucas10mauriz]

@Alaaelkazak, as mentioned by @Naiffer_Host the article provides an exploration of:

• Calculations of Metrics for Precision and Accuracy Evaluation,

• Calculation of Reproducibility and Repeatability %RSD from the Horwitz Function.

This piece not sheds light on aspects but also highlights important concerns that have captured the attention of regulators and stakeholders. Specifically it addresses the performance attributes inherent in these methodologies based on MS. The discussion around nitrosamines is constantly. This article reflects that.

[Alaaelkazak]

thanks alot for your reply.

[Alaaelkazak]

Thanks dear for your reply

[MarkS]

Finally the Horwitz equation/function is getting the limelight it deserves!!

Been trying to get people to adopt it for years. (ANVISA were ahead of the game including it in their method transfer guidance)

[Naiffer_Host]

For those interested in diving deeper…

The Horwitz Ratio -HorRat- A Useful Index of Method Performance.pdf (250.0 KB)

[Alaaelkazak]

Do we have here in the forum a list (or a post) to collect the validated methods either published by authorities or in literature esp. for NDSRI. I think this could help all the community esp. If we managed to collect the real experience and the specific challenges of colleagues worldwide implementing these methods, this will be of great value.

[Naiffer_Host]

@Alaaelkazak we do have couple resources:

• Category “Confirmatory Testing” where all analytical discussion are contain
• Analytical Hub - You can see the access at the header of the home page, The concept is to build a repository of analytical methods that have been curated by USP and make them available there.