Pharmaceuticals/Stability

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QUESTION: Hi,

The guidelines say that if you want to claim 12 month stability, you should test passed this date eg. 13 months. Does this mean that you need to test at 12month timepoint and again at the 13 month timepoint or is it ok to just test at 13months and if the results are acceptable, then claim 12months stability?

Thanks

ANSWER: Michelle:

I am not familiar with the requirement for a 13th month repeat test. Please advise which  guideline requires this - then I can respond.

---------- FOLLOW-UP ----------

QUESTION: For example the CLSI guidelines say to test passed the required stability period. Also I have heard QA reps say to test passed the required stability period.

Thanks for helping

Answer
Michelle:

Until your question I had never heard of CLSI, but I have now checked them out. All I can say is that they are not guidelines of standards put out by any national regulatory agency, and so I am not certain what their official standing is.

I tried to read the stability standard, but at US$ 130 to try to download, I have been unable to do so. Any chance you can send e a copy of the standard?

All regulatory agencies, especially US, EU, Canada, follow the ICH-Q1 stability guidelines which does not have the requirement you mentioned.

Sorry that I cannot assist further.
Best Regards,
Michael Anisfeld  

Pharmaceuticals

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Michael Anisfeld

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Disclaimer: SORRY BUT I DO NOT ANSWER QUESTIONS RELATED TO: DRUG ACTIONS/INTERACTIONS, INTERNET DRUG PURCHASES, RESULTS OF DRUG TESTS, IDENTIFYING DRUGS (FOR WHICH YOUR LOCAL PHARMACIST IS THE BEST PERSON TO CONSULT). My expertise is answering questions relating to pharmaceutical manufacturing and quality technologies, drug regulations and specifically GMP requirements

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