For a particular product we have 24 months stability study so we assign self life as a 36 months. After 36 months the batch tested if material is approved then how much retest period can extend maximum for that batch
First we have to perform stability study of product for accelerated and long term study of drug on 40/75 and 25/60 respectively. if the product is stable on 40/75 for 6 months than we can give 24 months directly.
Hi Gouth,
your question is not clear about the nature of product, is it for new drug substance and product or its for new dosage form?, taking your question in general form, as per ICH stability guidelines Q1E, if there is no significant change is observed in accelerated condition then long term and accelerated data to be reviewed for assigning the retest period. as per section 2.4.1.1 if not significant change is there in long term (which is 36 months in your case) then proposed retest period or shelf life can be up to twice, but should not be more than 12 months beyond the period covered by long term data.
for more details on if significant change is there and for significant change observed in accelerated condition please refer following guidelines (section 2.4.1)
Hope I answered your query.
What is Stability study requirement after cap opening in syrups and reconstituted syrups
@jehangir Please repost this question in new question section, as this will start a new discussion altogether.
What is Stability study requirement after cap opening in syrups and reconstituted syrups