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March-April-2015

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his is the fourth and final article meant to further the conversation and cooperative efforts between the pharmaceutical industry and wood packaging suppliers. Specifically, this fourth article will give an overview of the issue (general pallet control specific to the issue of 2,4,6 TBA and 2,4,6 TCA taints) by summarizing the first three articles and giving an update on recent events that have occurred regarding wood pallets and anisole taints. This effort was initiated due to the numerous prescription pharmaceutical and OTC (over the counter) products that were being recalled, starting in 2009, to determine if these recalls were truly a wood pallet issue (i.e. inherent to wood pallets) or a supply chain pallet management issue (i.e. would appropriate controls mitigate this issue). The goal of these initial discussions was to determine the root cause of the taints. The first three articles published by NWPCA focus on the following: 1. The first article gave background on the recalls and what is 2,4,6 TBA or 2,4,6 TCA, where do they come from and why wood pallets were originally thought to be the culprit of the taints and therefore the recalls. It also gave a non-pharma history of these taints related to the food and beverage industry, established from the Australian Food and Grocery Association booklet on taints. a. The conclusion was that (1) taints have been identified in the food and beverage industry (milk, beer, wines, etc.) for decades, and that (2) controls were needed by pharmaceutical manufacturers regarding pallet source, moisture control and storage. The term for these controls is GDP (Good Distribution Practices) 2. The second article focused heavily on controls needed at the sawmill and the pallet manufacturing site to eliminate the risk of taints in their products. It also focused on types of wood species, cleaning, and how pallet manufacturers can be proactive in mitigating the risk of these taints in their supply chain and manufacturing process, and how the pallet industry can partner with the pharma industries to educate on wood pallets. a. The conclusion was that pallet manufacturers and other industries that are susceptible to taints (food, beverage, pharma) need to work together with their suppliers so that consistent levels of controls are implemented and sustained. 3. The third article focused on controls needed by pharma manufacturers, and recommended that the "pallet management controls" that were in article #2 be integrated into their GDPs and part of their Supply Chain Integrity (SCI) plan. a. The conclusion was that these GDP controls are an extension of the pharma manufacturer's GMP (Good Manufacturing practices) and that (1) knowing the pallet manufacturer (and the source of their wood) and their controls, (2) implementing controls for storage and inspection (e.g. household clean) are adequate controls to mitigate this issue. 14 PalletCentral • March-April 2015 palletcentral.com T INDUSTRY Pharmaceutical Pallets By David Ulrich, Jorgelina González and Dr. Brad Gething

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