Advisory Committee on Infused Product Manufacturing Facility Experience
By Brandon Dunn
Monday afternoon the Advisory Committee on Infused Product Manufacturing Facility Experience consisting of Eric Hueste, Chief of Bureau of Environmental Health Services for Department of Health and Senior Services, Dr. Chris Riley President of Riley and Rabel Consulting Services, Ray McCarty President of Associated Industries of Missouri, and General Counsel Richard Moore acting as moderator, met to discuss questions and weigh importance for questions 134-144.
Questions listed as corrected, amended, and approved below.
134 Describe your experience, including the experience of any retained contractor, consultant, or employee, in food, beverage, and nutraceutical manufacturing, including any relevant experience with medical marijuana. Critically Important
135 Will the facility consult with or hire a qualified chemist, pharmacist (with manufacturing or compounding experience), food scientist, or chemical engineer for consultation to establish their processes? If yes and the individual(s) are known, provide the education and relevant experience of each individual. Important
136 Will the facility consult with or hire a qualified chemist, pharmacist (with manufacturing or compounding experience), food scientist, or chemical engineer for consultation after the processes are established? If yes and the individual(s) are known, provide the education and relevant experience of each individual. Important
137 Describe your experience, including the experience of any retained contractor, consultant, or employee, with extraction of chemicals from plant materials. Critically Important
New Question Added Describe in detail the air-handling systems to ensure worker safety. Highly Important
138 In addition to testing, describe the systems you have implemented, or plan to implement, to ensure the consistency of the ingredients in the product, to ensure that a) all the ingredients listed on the label are present, and b) any percentages of ingredients listed on the label are accurate. Critically Important
139 Deleted – Original Text : Describe your experience related to recalls.
140 Describe the system you plan to implement to ensure unacceptable products released into the market are recalled. Highly Important
141 Describe your plans for waste storage and destruction. Highly Important
142 Describe the system you plan to implement for handling flammable materials, explosive materials, and asphyxiates (such as carbon dioxide) to ensure worker safety and protection of the environment. Critically Important
143 Describe your experience, including the experience of any retained contractor, consultant, or employee, and plans for quality control and quality assurance of products. Critically Important
144 Deleted – Original Text : Has the applicant ever been subject to a civil monetary penalty, criminal prosecution, seizure, or injunction by the FDA for practices in food or beverage manufacturing? (If yes, please list)