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.
Available to download
Format: PDF (1 file 1.85 MB)
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Table of Contents:
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Introduction
- Complaints Handling System (Questions 1-7)
- Supply Chain Controls (Questions 8-26)
- Analytical Methods (Questions 27-30)
- Regulatory Focus (Questions 31-32)
- Conclusions