CURRENT AFFAIRS

2018

Question [CLICK ON ANY CHOICE TO KNOW THE RIGHT ANSWER]
Which of the following Active Pharmaceutical Ingredient got its Establishment Inspection Report from USFDA?
A
Dr.Agarwal’s
B
Dr.Vasan’s
C
Dr.Reddy’s
D
Dr.Aravind’s
Explanation: 

Detailed explanation-1: -An active ingredient is any component that provides pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or animals.

Detailed explanation-2: -The Establishment Inspection Report article provides you information about the inspection visit report preparation after goods inspection or preshipment inspection. When the third party or second party inspector did inspection on the equipment must supply the report to his customer.

Detailed explanation-3: -An API process is a related series of operations which result in the preparation of an active pharmaceutical ingredient. Major operations or steps in an API process may include multi-step chemical synthesis and fermentation, purification, crystallization, drying, milling, packing, labeling, and testing.

Detailed explanation-4: -EIR is the name given by the US Food and Drug Administration (US FDA) for an entire narration of what the FDA investigator / inspector did during the time spent at the establishment (facility), from the stage of introductions till the handover of the inspectional observations (termed as Form FDA 483).

There is 1 question to complete.