Electronic PDA Technical Reports

PDA Technical Report No. 55 (TR 55) Detection and Mitigation of 2,4,6-Tribromoanisole and 2,4,6-Trichloroanisole Taints and Odors in the Pharmaceutical and Consumer Healthcare Industries (single user digital version)

This PDA technical report provides guidance on how to detect and mitigate TBA and TCA odors and taints. Well recognized in the food and beverage industries, the literature features knowledge from these industries regarding the origin of these odors and taints, analytical methods developed, and risk management strategies employed. In 2009, this became an issue for the pharmaceutical and consumer healthcare industries with product recalls from four companies due to the risk of product exposure to the TBA taint from tribromophenol-treated wood pallets. Recalls from additional firms continued through 2011.

The TBA/TCA Task Force worked very rapidly in response to the pressing need within industry for guidance on this topic. Formed at the end of 2010, the group drafted one of the most comprehensive technical reports in PDA's library in record time.

This report provides background on issues with TBA and TCA taints, highlighting:

  • Uses of 2,4,6-tribromophenol (TBP) and 2,4,6-trichlorophenol (TCP) in industry
  • Role of fungal halophenol methylation that generates TBA and TCA haloanisole taints
  • Sensory and physiochemical properties of TBP, TCP, TBA and TCA
  • Case examples from food and beverage industries with root causes and remedial actions
  • Recent examples of TBA taint recalls from the pharmaceutical and consumer healthcare industries

    Additionally, this report offers guidance on signal detection from adverse event and/or product quality complaints and resulting recalls, toxicology and safety, analytical method development and use, supply chain controls, risk analysis and mitigation. Definitions of technical terms used in this report can be found in the glossary. The principles and tools used to manage these taints are also defined in this report.

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    Format: PDF (1 file 2.30 MB)

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  • Table of Contents:

    Click here to download >>> Table of Contents

    1. Introduction
    2. Glossary of Terms
    3. Principles and Tools
    4. Industry Benchmarking
    5. Distribution Flow
    6. Analytical
    7. Product Quality Complaints, Adverse Events, Notification to Regulatory Agency, and Recall Procedures
    8. Toxicology and Safety
    9. Quality Risk Management
    10. Conclusion
    11. Appendix
    12. Acronyms
    13. Additional Reading Material
    14. References
    15. Figures and Tables Index

    Date of Publication: March 2012
    ISBN Number: 9780939459391
    Format: PDF
    Number of Pages: 91