Ensuring Product Safety and Reliability in the Health Science Domain
Our Quality Assurance Practices in the Health Science Domain
In the Health Science domain, our Research and Development Department, Quality Compliance Section, the academic division, and Kirin Group companies that manufacture and market health science products all work together in promoting quality assurance that starts from fundamental research into materials and ingredients and extends to product development and post-launch follow-ups.
We leverage technologies accumulated in our Food & Beverages and Pharmaceuticals domains as well as our wealth of advanced fermentation and bio technologies to conduct a wide range of fundamental research into materials and ingredients. When developing new health science products, each Group company utilizes the developed materials and conducts quality assessments in a manner tailored to each product type. During this process, the Quality Compliance Section evaluates the safety and effectiveness of materials and products across the value chain as part of its efforts to implement upgraded quality assurance practices in the Health Science business.
Initiatives in Foods with Function Claims
Here we introduce our initiatives for safety and reliability in the Health Science domain, using foods with function claims as an example.
Initiatives in Reliability Assurance
Japanese regulations require that manufacturers of foods with function claims submit a notification to the authorities before starting to market them that the claims are supported by scientific evidence and meet regulatory requirements. This procedure is different from the one applied to foods for specified health use, which requires manufacturers to submit samples to regulatory authorities for test and approval.
To ensure that our function claims are scientifically valid, in 2014, before the system of "Foods with Function Claims" was launched, we have established the Quality Compliance Section, responsible for validating supporting data and function claims—independently of Kirin Group companies and the departments responsible for conducting fundamental research, developing food and beverage products, submitting the Consumer Affairs Agency, and manufacturing and marketing them.
The Quality Compliance Section, while an in-house organization, strictly checks the validity of scientific evidence and labeling from a third-party standpoint throughout the entire process, from material research to product launch and post-launch follow-ups.
Roles Kirin Group Companies and Departments Play for Foods with Function Claims
Flow from Fundamental Research for Materials to Post-Launch Follow-Ups
Confirmation of safety and effectiveness
A high level of expertise is required to obtain, investigate, and evaluate scientific evidence regarding the safety and effectiveness of foods with function claims. Therefore, in each process from fundamental research into materials to product development and post-launch follow-ups, each department confirms the safety and effectiveness of the product while demonstrating its expertise.
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*Press the words Fundamental Research into Materials, Product Development, or Post-Launch Follow-Ups to toggle the display.
Role of the R&D Department
The safety of functional materials and functional substances is evaluated from the fundamental research into materials stage by the R&D Department. Specifically, to evaluate safety, we conduct surveys of history of consumption and clinical trials (human studies) in accordance with our own safety evaluation standards that conform to the system of "Foods with Function Claims". For effectiveness, we identify the functional substances in the functional material to clarify the mechanism of action, and evaluate the scientific basis for the function to be claimed through clinical trials (human studies) or systematic literature reviews.
Role of the Quality Compliance Section
Confirmation of safety and effectiveness does not end with the R&D Department alone. The Quality Compliance Section, a third-party organization within the company, evaluates from a scientific perspective whether the information on the basis of safety and effectiveness of functional materials and functional substances evaluated by the R&D Department are appropriate. If the rationale is deemed insufficient, the R&D Department will be requested to reevaluate.
Role of the Academic Division (Institute of Health Sciences)
A number of documents related to safety, effectiveness, manufacturing, quality control, and so forth are required to submit a notification to the Consumer Affairs Agency for a product that has been developed. Among them, the academic division prepares materials related to scientific evidence of safety and effectiveness, which are important for foods with function claims, based on safety information from history of consumption surveys and clinical trials (human studies) , and effectiveness information from clinical trials (human studies) and systematic literature reviews. The academic division also plays a role in compiling the notification plans of each business company.
Role of Group Companies
Under the system of "Foods with Function Claims", the amount of functional substances in the product must be maintained during the sales period (or the expiration date or best-by date, if indicated). We therefore verify the stability of the functional substances through storage tests and determine the formulation to ensure that the indicated amount is maintained during the relevant period.
Role of the Quality Compliance Section
The Quality Compliance Section confirms the conformity to the system of "Foods with Function Claims" and the scientific validity of all prepared notification materials (notification forms and related attached materials concerning safety, effectiveness, manufacturing, quality control, etc., including packages).
Role of the Academic Division (Institute of Health Sciences)
Even after a product is launched as a food with function claims, we regularly collect and investigate new literature. In addition, we collect and investigate reports from domestic and international research institutions, as well as information from physicians, academic groups, government agencies, and consumer groups.
Role of Group Companies
Each Group company that manufactures and sells products conducts post-launch follow-ups in cooperation with each relevant department to ensure the scientific validity of safety and effectiveness of products on the market continuously.In addition to periodically analyzing and confirming that the content of functional substances in products is maintained, we collect health information from consumers and reflect it in future product design.
Role of the Quality Compliance Section
The Quality Compliance Section scrutinizes information on safety and effectiveness, results of content analysis of functional substances, and adverse health events information collected within the Group companies and evaluates whether or not there is any impact on the existing scientific evidence.