Warning Letter of the Week: naughty sonicator edition

Warning Letter of the Week: naughty sonicator edition Hello friend AMERICAN WORKERS LOOKING FOR JOBS, In the article you read this time with the title Warning Letter of the Week: naughty sonicator edition, we have prepared this article well for you to read and take information in it. hopefully the contents of the post Article bank, Article contracting, Article health, Article lecturer, Article manufacturing, Article marketing, Article property, Article public, Article teachers, Article telecommunications,what we write can you understand. okay, happy reading.

Judul : Warning Letter of the Week: naughty sonicator edition
link : Warning Letter of the Week: naughty sonicator edition

Baca juga


Warning Letter of the Week: naughty sonicator edition

From a letter to the Director of CTX Lifesciences Private Ltd. from the Center for Drug Evaluation and Research: 
2.    Failure to adequately investigate out-of-specification results and implement appropriate corrective actions. 
You invalidated an out-of-specification (OOS) related substances test result for API [redacted] batch [redacted], listed in a pending drug application, without scientific justification. 
In your response, you stated that you performed an investigational hypothesis study to evaluate the effect of sonication on API [redacted] batch [redacted]. You concluded that [redacted] generated an unknown impurity at the same relative retention time (RRT) and similar percentage peak area as the OOS result. 
Your response is inadequate because you did not adequately investigate all potential causes of the unknown impurity. You attributed the OOS result to degradation caused by [redacted], a sample preparation step performed during your test procedure. You also did not provide adequate scientific justification for your OOS result root cause. We note that three other batches of API [redacted] followed this [redacted] preparation and analysis procedure during the same sequence with no OOS results for these [redacted] batches.
Blaming the sonicator is a new one on me! 


Such is the article Warning Letter of the Week: naughty sonicator edition

That's an article Warning Letter of the Week: naughty sonicator edition this time, hopefully it can benefit you all. well, see you in other article postings.

You are now reading the article Warning Letter of the Week: naughty sonicator edition with the link address https://americanworkerslooking.blogspot.com/2019/08/warning-letter-of-week-naughty.html

Subscribe to receive free email updates:

Related Posts :

0 Response to "Warning Letter of the Week: naughty sonicator edition"

Post a Comment