On March 8, 2023, the US Food and Drug Administration announced proposed Tobacco Product Manufacturing Practice (TPMP) requirements for manufacturers of finished and bulk tobacco products. The agency is not unaccustomed to requiring FDA regulated product manufacturers to comply with manufacturing standards as other commodities regulated by FDA have done so for decades. These proposed requirements will help protect public health by minimizing or preventing contamination, incorporating traceability down to the ingredients, reducing additional risks to the users and non-users and ensure product conformity and consistency. The tobacco product category is very diverse ranging from cigarette, smokeless and ENDs, to dissolvable, heated tobacco products, cigars and many more products all with distinct design parameters and manufacturing processes. According to the agency, tobacco manufacturers over the years have incorporated some elements of quality management systems to support their manufacturing processes (based on previous inspections of the establishments). As the proposed TPMP rule undergoes the rulemaking process, it provides ample time for tobacco manufacturers to either establish and implement a Quality Management System (QMS) that will comply with all requirements in the proposed TPMPs or conduct a robust assessment of the current QMS in place with a gap analysis to ensure compliance with future TPMPs. The poster will provide an overview of the proposed TPMP requirements highlighting the differences between existing GMPs, identify the keys to successfully conducting a gap analysis of manufacturing processes and the proposed TPMP and discuss best practices for implementing changes to manufacturing processes to comply with the TPMP rule.