Friday 14 December 2012

Help on: How Many Times can System Suitability Tests be Repeated?

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“How many times can a system suitability test for an HPLC method be repeated?”
“If your question refers to repeating the system suitability test after a failure without making any changes to the system then the number of times this can be done is zero. The reasoning for this statement is as follows: The purpose of the test is to check that the method is performing as expected, if it fails then it indicates that there is a problem and then the source of that problem needs to be identified and corrected before the system suitability can be performed again. Admittedly, on many occasions only a probable cause can be identified and an investigation will involve making a change and then using the system suitability test to see it the problem has been corrected. Therefore, provided that there is a justifiable reason (some type of hypothesis about what has caused the failure) each time the test is carried out, I can see no reason why there should be a limit of the number of times the system suitability test is performed. The aim is to ensure that the method is completely controlled by the analyst.”

Thursday 6 December 2012

MTS Recommends... Forced Degradation Studies in ANDA Submissions

The author outlines the scientific aspects of forced degradation studies that should be considered in relation to ANDA submissions.