- Author(s):
- Organization(s):
Gateway Analytical
The FDA’s actions indicate identification and source determination—not merely detection—of contaminants is necessary.
Utilizing a forensic approach to foreign particulates in drug products can play a unique and important role in quality control. In order to source contamination and thereby design a controlled environment to avoid contamination in the future, one must begin with an identification of the material, not just the detection of it.