veeprho marketing's articles What is Out of-Specification Investigation and How to Proceed for it? Background: FDA issued warning letter to the most of the drug substance and drug product manufacturer. During the inspection, FDA find out the fault, the way investigation of OOS had been carried out by the manufacturer. There is no proper investigation of OOS outcome. FDA warning letters often found that the procedure for handling of […] March 15, 2021March 15, 2021 Saving Bookmark this article Bookmarked
What is Out of-Specification Investigation and How to Proceed for it? Background: FDA issued warning letter to the most of the drug substance and drug product manufacturer. During the inspection, FDA find out the fault, the way investigation of OOS had been carried out by the manufacturer. There is no proper investigation of OOS outcome. FDA warning letters often found that the procedure for handling of […] March 15, 2021March 15, 2021 Saving Bookmark this article Bookmarked