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Pharmaceuticals/What is the acceptable time period for withdrawal of stability sample


Good morming Mr. Michael,

please provide answer for the following question

1)I incubated X product in stability chamber, its 6 month withdrawal period was 10/9/2013 as per stability withdrawal schedule. But due to some reason I withdrew on 19/09/2013. Is it possible (or) valid to withdraw sample after 10days later. Are there any time limits for the stability sample withdrawal acceptable time limits?
2)What is the acceptable time period for withdrawal of stability sample?
3)Is there any time limit for incubation of samples after manufacturing of the batches i.e. if the batch was manufactured on January is it possible to incubate the samples after 3 or 6 months from the manufacturing date?



Dear Mr. Reddy:

FDA used to have a guideline on this (OGD 1983) since withdrawn, that stated:

a. samples 3-months or under: pull -0/+3 days from target
b. samples 6, 9 or 12 months: pull -0/+7 days from target
c. samples 18 months or over: pull -0/+14 days from target

You obviously have a deviation which needs to be investigated, and preventive action implemented; as for the data point, report it as is (not faked to be 6 months), and determine any impact on the study. If this was a room temperature study there is probably no impact; if this was an accelerated study there might be impact.

Stability study incubation typically starts within one week of the date of manufacture (which is the date that the constituent ingredients come together (powder blending or liquid mixing).

I hope this helps.


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Michael Anisfeld


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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