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