Standards/Testing Methods for Cosmetics and Quasi-drugs: Basics and Key Points for Plant Ingredients
S30522
~Tips for creating appropriate standards, testing methods, and application materials for components~
【Keywords】 1. Basic utilization methods of official documents for setting standards for cosmetic ingredients 2. Common issues pointed out during the review process 3. Analytical methods for establishing standards and testing methods for so-called medicated cosmetics 【Lecture Summary】 Quasi-drugs and cosmetics, like pharmaceuticals, are used on humans, and manufacturers are responsible for the overall product. Quasi-drugs consist of various ingredients, many of which are specified in various official documents and notifications regarding standards and verification methods. However, for ingredients classified as Category 1 or Category 3, it is necessary to create new application materials. Therefore, the standards for quasi-drug ingredients and the Japanese Pharmacopoeia serve as references, but in individual cases with diverse types and forms, it is not easy to interpret the content and intent indicated in the official documents and notifications and to establish appropriate standards and testing methods for those ingredients. Thus, this lecture aims to explain the perspective on various official documents and the analytical methods underlying the standards and testing methods for quasi-drug ingredients.
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【Venue】 Tekuno Kawasaki 4F Conference Room 【Kanagawa, Kawasaki】 【Date and Time】 May 22, 2013 (Wednesday) 13:30-16:30 【Instructor】 Professor Naoshi Kojima, Faculty of Medical Sciences, Teikyo University of Science
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If you are adding an application from the same corporation, it will be 18,900 yen (including tax and text costs) per person.
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P2
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P2
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**Program** 1. Understanding of relevant official documents such as standards for quasi-drugs 1) Basics and interpretation of various official documents and guidelines ○ Standards for Quasi-drugs 2006 (GQP) ○ 16th Revision of the Japanese Pharmacopoeia (JP) ○ Various guidelines, etc. 2) Comparison and differences between official documents such as JP and GQP ○ Differences including food additives and pharmaceutical additives 2. Fundamentals and practical aspects of creating standards and testing methods for quasi-drugs 1) Essential items to be set in standards and testing methods 2) Testing items to be set in standards and testing methods 3) Basic considerations for other items Heavy metals, arsenic, principles of confirmation tests and quantitative methods, actual standards for reference materials, etc. 3. Setting standards for approval applications based on test results 1) Scope of standards to be set for quality assurance 2) Considerations for evaluating results to set standards based on raw materials and items, etc. 4. Standards testing and implementation based on analytical validation (Practical support to enhance the reliability of test results) 1) Basics of physicochemical analysis and measurements necessary for setting standards 2) Maintenance of instrumental analysis, traceability of instruments and equipment, etc. **[Q&A and Business Card Exchange]**
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