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Risk Mitigation of Tribromoanisole (TBA)/Trichloroanisole (TCA) Taints and Odors: A Pharmaceutical Industry Benchmarking Survey (single user digital version)

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The issue of Tribromoanisole (TBA) or Trichloroanisole (TCA) tainting is relatively new to the consumer healthcare and pharmaceutical industries. Since early 2010, there have been multiple drug and consumer healthcare product recalls for musty/moldy odors and lack of experience with taints in our industry led to the formation of a PDA-sponsored task force to define the issue and develop risk mitigation strategies. This benchmarking survey was distributed by the task force in 2011 and led to the publication of 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, which was published in 2012.

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Table of Contents:

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Introduction

  1. Complaints Handling System (Questions 1-7)
  2. Supply Chain Controls (Questions 8-26)
  3. Analytical Methods (Questions 27-30)
  4. Regulatory Focus (Questions 31-32)
  5. Conclusions

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