Successfully reported this slideshow.
Gateway Analytical<br />Pharmaceutical Forensic Services<br />
Pharmaceutical Forensic Services<br />© Gateway Analytical, LLC, 2011<br />- Non-Conformance Issues<br />- OOS Investigati...
Pharmaceutical Forensic Services<br />- Foreign Particulate<br />  Matter Identification<br />© Gateway Analytical, LLC, 2...
Foreign ParticulateWhat is it?  Where did it come from?<br />© Gateway Analytical, LLC, 2011<br />100<br />100<br />80<br ...
Pharmaceutical Forensic Services<br />© Gateway Analytical, LLC, 2011<br />- Product Return Analysis<br />- Source Determi...
Parenteral Drug Visible Inspection Support<br />© Gateway Analytical, LLC, 2011<br /><ul><li>Vial selection should include...
Microscopic analysis
Rinse studies on multiple vial lots
Foreign particulate studies on multiple vial lots
Upcoming SlideShare
Loading in …5
×

Pharmaceutical Forensics: Advanced Problem Solving Techniques for Pharma Deviations

1,378 views

Published on

Pharmaceutical forensics applies forensic expertise, analysis and problem solving principles to pinpoint when and where foreign particulate matter entered a manufacturing process, the root cause of product failures or the source of product stains or discoloration.

  • Be the first to comment

  • Be the first to like this

Pharmaceutical Forensics: Advanced Problem Solving Techniques for Pharma Deviations

  1. 1. Gateway Analytical<br />Pharmaceutical Forensic Services<br />
  2. 2. Pharmaceutical Forensic Services<br />© Gateway Analytical, LLC, 2011<br />- Non-Conformance Issues<br />- OOS Investigations<br />- Particle Contamination<br />Characterization<br />
  3. 3. Pharmaceutical Forensic Services<br />- Foreign Particulate<br /> Matter Identification<br />© Gateway Analytical, LLC, 2011<br />- Glass Defect Analysis<br />- Product/Process Contamination Consultation<br />
  4. 4. Foreign ParticulateWhat is it? Where did it come from?<br />© Gateway Analytical, LLC, 2011<br />100<br />100<br />80<br />80<br />60<br />60<br />40<br />40<br />20<br />20<br /> 4000 <br /> 3500 <br /> 3000 <br /> 2500 <br /> 2000 <br /> 1500 <br /> 1000 <br /> 4000 <br /> 3500 <br /> 3000 <br /> 2500 <br /> 2000 <br /> 1500 <br /> 1000 <br />SEM / EDS Spectra<br />Optical Image<br />Infrared Spectra<br />Absorbance<br />Wavenumber cm-1<br />Silicone<br />
  5. 5. Pharmaceutical Forensic Services<br />© Gateway Analytical, LLC, 2011<br />- Product Return Analysis<br />- Source Determination<br />- 100% Particle Inspection <br />- AutomatedParticleSizing and Identification<br />
  6. 6. Parenteral Drug Visible Inspection Support<br />© Gateway Analytical, LLC, 2011<br /><ul><li>Vial selection should include extensive evaluation
  7. 7. Microscopic analysis
  8. 8. Rinse studies on multiple vial lots
  9. 9. Foreign particulate studies on multiple vial lots
  10. 10. Sterile does not mean particle free!
  11. 11. Foreign particulate accounts for hundreds of 483’s each year
  12. 12. 100% Inspection Testing and Consulting Support
  13. 13. Characterization and source determination are critical to resolution of visible particulate non-conformance investigations</li></li></ul><li>Detailed Analysis of Defects<br />© Gateway Analytical, LLC, 2011<br /><ul><li>How was the glass broke?
  14. 14. Mechanical or Thermal?
  15. 15. Was glass exposed to product?</li></li></ul><li>Why Choose Gateway Analytical?<br />- Experienced scientists who specialize in applying forensic methods to pharmaceutical-related issues<br />© Gateway Analytical, LLC, 2011<br />- Regulated laboratory environment complying with cGMP and conforming to ISO guidelines<br />
  16. 16. Why Choose Gateway Analytical?<br />- Trusted quality system rooted in Quality by Design (QbD) principles<br />© Gateway Analytical, LLC, 2011<br />- Proven history of excellent customer satisfaction<br />- State-of-the-art analytical instrumentation and methods<br />

×