The Tobacco Control Act (TCA) was enacted on June 22, 2009. One aspect of this new regulation requires tobacco manufacturers (> 350 employees) and importers to adhere to Good Manufacturing Practices (GMP) and/or Hazard Analysis and Critical Control Point Methodologies to ensure the safety of their products. Additionally, data and information on ingredients, levels of ingredients and packaging testing data would need to be maintained. Lastly, TCA empowered the FDA to audit the tobacco manufacturers and importers every two (2) years.
A large Tobacco Manufacturer was concerned that their in-house developed LIMS-like system which was supporting its manufacturing and R&D organizations was not going to be able to support the data and information needs nor the new, more stringent regulatory requirements that the TCA mandates…
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