Sir, my self Rajib As u told 12 times need to be kept. I m also preparing the dossier part and we are mentioning the exhibit batch no is already available at the site in the warehouse with control room temperature and that samples are more then sufficient considering 12 times. And in commercial mfg we use to keep 2 times.
The requirement is is for Drug substances as well as drug products. The explanation you are giving is for drug product. But the requirement is for drug substances also. So, API retention sample also 12 times analysis.
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Sir, my self Rajib
As u told 12 times need to be kept. I m also preparing the dossier part and we are mentioning the exhibit batch no is already available at the site in the warehouse with control room temperature and that samples are more then sufficient considering 12 times. And in commercial mfg we use to keep 2 times.
The requirement is is for Drug substances as well as drug products. The explanation you are giving is for drug product. But the requirement is for drug substances also. So, API retention sample also 12 times analysis.