• Publication Date: 08/01/2013
  • Author(s):
    Byrne, Rebekah L. Exline, David
  • Organization(s):
    Gateway Analytical
  • Article Type: Technical Articles
  • Subjects: Device Design, Particle Characterization, Product Development/Formulation
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.

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