자외선차단제의 글로벌 진출을 위한 국가별 제조 및 품질관리 방안 고찰

다국어 초록 (Multilingual Abstract)

Abstract

The sales of cosmetics in Korea have grown steadily even in the difficult circumstances of the global economic recession and COVID pandemic, but now become the world’s third largest export of cosmetics. Although the activity of marketing to promote export and sale for various countries are important, the steps to confirm the law or rule for cosmetic products by countries are also essential.
Among cosmetics, sunscreen has been classified as a cosmetic in China, Japan, Europe, and Korea, there is no restriction on exporting the products manufactured in Korea to these countries. However, only the United States classified sunscreen as an OTC drug, so it is not possible for the product in Korea to directly export to the United States. For this reason, this study is designed to provide a guideline for domestic cosmetic manufacturers to produce and export sunscreen that can meet the rules according to the countries by investigating the raw and rules and confirming the classification guideline of the sunscreen in the major importing countries.
By finding out the active ingredients of sunscreens with different classification standards by countries, effectiveness evaluation (SPF testing and labeling), expiration date setting and marking method, labeling regulations, and factory registration method, and by examining items such as test method validation, facility, and equipment qualification evaluation, cleaning and process validation, stability test, and annual product evaluation that must be performed on sunscreens exported to the United States, it is possible to suggest the guideline for those companies have a plan of production to export of sunscreen, and the chances to find out any items whether missed or not.

목차 (Table of Contents)

• Ⅰ. 서론 1
• 1.1 연구배경 1
• 1.2 연구 목적 5
• 1.3 연구 항목 및 방법 6
• 1.3.1 연구항목 6
• 1.3.2 연구 방법 7
• Ⅱ. 연구에 관한 이론적 배경 8
• 2.1 자외선차단제의 정의 및 종류 8
• 2.2 자외선차단제의 국가별 품목 분류 9
• 2.3 적용 법령 12
• Ⅲ. 연구 결과 14
• 3.1 제품 개발 단계 14
• 3.1.1. 활성성분(Active ingredients) 14
• 3.1.2 유효성 평가(SPF Testing) 21
• 3.1.3 시험방법 밸리데이션 (Analytical Method Validation) 25
• 3.1.4 사용기한 설정 27
• 3.1.5 라벨링 (Labeling) 31
• 3.2 제품 생산 단계 33
• 3.2.1. 공장등록 (Establishment Registration) 33
• 3.2.2. 시설, 설비 적격성평가 (Qualification) 35
• 3.2.3 세척 밸리데이션 (Cleaning Validation) 38
• 3.2.4 공정 밸리데이션(Process Validation) 50
• 3.2.5. 안정성 시험 (시판 후 안정성 확인) 55
• 3.2.6. 연간 제품 평가 (Annual Product Review) 56
• Ⅳ. 결론 및 고찰 58
• 4.1 연구에 관한 이론적 배경 요약 58
• 4.2 연구 결과의 요약 59