TSRC, Tob. Sci. Res. Conf., 2018, 72, abstr. 002 (Symposium)

A risk-based approach to tobacco product development & control

ITG Brands LLC, Greensboro, NC, USA

The Tobacco Industry does not appear to have a model that identifies those attributes of a product’s characteristics and manufacturing processes having the greatest impact on a finished tobacco product’s quality and compliance. As a result, regulators seem to consider all attributes of a tobacco product with the same criticality. This presentation proposes that a flexible regulatory framework for tobacco products could be achieved by utilizing a risk-based end-to-end control strategy similar to that established in the pharmaceutical industry. A control strategy is the description of the product, manufacturing process, facilities and equipment, and assurance elements that provides confidence in the consistency and quality of a product. The first step of this approach is to clearly define the adult consumer’s expectations of quality for a product’s intended use. Only after that is defined, can a risk-based approach to tobacco product development and delivery enable a fit-for-purpose control strategy commensurate to expected quality, complexity and required compliance. An effective control strategy identifies product characteristics that are critical to meeting these predefined expectations. These critical characteristics are then evaluated by assessing the extent to which their variation can have negative impact on the finished tobacco product. Proportional controls are then designed in order to achieve the quality as defined in the first step. Once controls are identified and established, those critical attributes, or the process controls, should then be monitored to ensure that the product is consistently meeting quality and compliance expectations. Using a risk-based approach ensures that the quality for intended use, product characteristics and manufacturing and supply chain complexity is considered in order to differentiate between simple products that may only require end-product testing and complex products that may require in-process controls and more release testing. It should be noted that a control strategy, for any tobacco product, should reflect of the level of maturity and effectiveness of the quality management system in place. As in the pharmaceutical industry, it should also be recognized that the quality of knowledge gained and provided to a regulatory agency, and not the quantity of data, should be the basis for regulatory evaluation. Ultimately, a well-articulated and executed control strategy can consistently deliver the intended quality and compliance of a tobacco product. This approach should be considered as part of a reasonable regulatory framework that provides value for the adult consumers by ensuring consistent quality while providing options and access to new harm reduction products by reducing regulatory burden and cycle times. This proposal is based on International Standards on Harmonization (ICH) Quality Guidelines (Q8, Q9 & Q10). References: • PHARMACEUTICAL DEVELOPMENT Q8(R2) Current Step 4 version dated August 2009 • QUALITY RISK MANAGEMENT Q9 Current Step 4 version dated 9 November 2005 • PHARMACEUTICAL QUALITY SYSTEM Q10 Current Step 4 version dated 4 June 2008