Pharmaceutical Forensics

Pharmaceutical forensics is the application of forensic testing methods to address such pharmaceutical issues as identifying when and where particulate contamination enters a manufacturing process, pinpointing the root cause of drug contamination or investigating the source of product stains or foreign particulate matter.

Through our pharmaceutical forensic services, Gateway Analytical takes an investigative approach to problem solving based on our extensive experience in leveraging materials analysis, characterization and source determination to provide guidance in the remediation of any issues. Our forensic scientists specialize in materials characterization techniques that can reveal more about product and process deviations, as well as providing consulting support for quality system operations and remediation of contamination sources.

Pharmaceutical forensic services include:

  • Foreign Particulate Matter Identification
  • Non-conformance Investigation
  • OOS Investigation
  • Deviation Investigation
  • Particle Contamination Characterization
  • Source Determination
  • Counterfeit Investigation
  • Failure Analysis

Instruments and Techniques:

  • Sample isolation and preparation lab
  • Fourier Transform Infrared (FTIR) Spectroscopy
  • Scanning Electron Microscopy/Energy Dispersive Spectroscopy (SEM/EDS)
  • Raman spectroscopy and imaging
  • Optical microscopy