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국내 화장품 GMP와 ISO 22716 간 비교 분석 및 국제 조화 방안 연구

원문정보

Comparative Analysis of Domestic Cosmetic GMP and ISO 22716 and Strategies for International Harmonization

설주은, 한신웅, 이현정

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초록

영어

The global cosmetics industry is expanding rapidly, and compliance with internationally recognized Good Manufacturing Practices (GMP) has become essential for market competitiveness. Korea’s cosmetic manufacturers must adhere to both Korea’s GMP (KGMP) and international standards such as ISO 22716, as required by major export markets like the United States, the European Union (EU), China, and ASEAN countries. This dual compliance places a significant burden on businesses, highlighting the need for regulatory harmonization. To address this, the Ministry of Food and Drug Safety (MFDS) revised Korea’s GMP in August 2024, aligning key elements—such as terminology, facility standards, and reprocessing criteria—with ISO 22716 and global GMP frameworks. While this revision strengthens Korea’s global competitiveness, challenges remain in regulatory effectiveness, integration with existing certification systems, and reducing compliance burdens on businesses. This study analyzes the key differences between Korea’s GMP and international standards (ISO 22716, EU, U.S., Japan, China, and ASEAN countries) to propose policy improvements for enhanced compliance. By aligning Korea’s GMP framework with global standards, this research seeks to reduce regulatory redundancy, alleviate compliance burdens on manufacturers, and improve market accessibility. These findings contribute to the longterm competitiveness and sustainable growth of Korea’s cosmetic industry.

목차

Abstract
I. 서론
II. 연구방법
III. 연구결과
1. 국내외 화장품 GMP 규정 개요
2. 국내 화장품 GMP 규정과 ISO 22716 간의 비교 분석
IV. 고찰
V. 결론
감사의 말씀
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저자정보

  • 설주은 Ju Eun Seol. 인제대학교 글로컬대학30 바이오메디컬센터, 심혈관 및 대사질환 핵심연구지원센터
  • 한신웅 Shinwoong Han. 아주대학교 분자과학기술학과
  • 이현정 hyeon jeong Lee. 아주대학교 응용화학생명공학과

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자료제공 : 네이버학술정보

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