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Pharmaceutical Blend and Content Uniformity (BUCU) Analysis using ASTM E2709 / E2810

Status: Not Planned For Now Submitted by on ‎02-06-2023 12:45 PM
3 Comments (3 New)

What inspired this wish list request? The FDA is putting increased emphasis on BUCU evaluation using ASTM E2709 / E2810.  See FDA "."

 

What is the improvement you would like to see?  The International Society of Pharmaceutical Engineers (ISPE) published the CuDAL program that can analyze data to determine if it meets the ASTM requirements.  This program runs on SAS.  The improvement being requested is for JMP to have the ability to run the CuDAL program.

 

Why is this idea important? The ease of use and availability of JMP for laboratory analysts when compared to SAS.

 

 

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3 Comments
Gus_GrayHair
Level II
‎02-06-2023 12:50 PM
‎02-06-2023 12:50 PM

Sorry.  Lost in translation for "what inspired this request" was the link to the FDA Questions and Answers on Current Good Manufacturing Practice Regulations, Production and Process Controls, Questions/Answers for 15-18."

Sarah-Sylvestre
Staff
Staff
‎02-08-2023 04:25 PM
‎02-08-2023 04:25 PM
Status changed to: Acknowledged

Hi @Gus_GrayHair, thank you for taking the time to submit this idea! We will review your request and keep you updated on its status. 

SamGardner
Staff
Staff
‎03-31-2023 04:49 PM
‎03-31-2023 04:49 PM
Status changed to: Not Planned For Now

@Gus_GrayHair thanks for the idea!  I am a member of the USP Statistics Expert Committee and there has been a lot of discussion about this procedure and USP <905>.  

This seems to be a good candidate for a JMP Addin, as opposed to a direct feature in JMP.  Anyone in the community that would like to collaborate on an addin to implement the CUDAL algorithms, let me know.