industrial 4 job

 1.What is Out of specification (OOS)? Defined as those results of in process or finished product testing that does not comply with the pre-determined acceptance established in drug applications, drug master files (DMFs), official compendia, or by the manufacturer. 2.What is Out of trend (OOT)? result that does not follow the expected trend, either in comparison with previous results with other stability batches or with respect to previous results collected during a stability study. 3.What is Bioassay? is an analytical method to determine the concentration or potency of a substance by its effect on living cells or tissues. 4.What is Biomarker? is defined as a measurable indicator that can be used to a particular disease state or some other biological state of an organism. 5.What is Precision? The precision of an analytical procedure refers to the closeness of agreement between a series of measurements obtained from multiple sampling of the same homogeneous sample under the prescrib...