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| 발행년 : | 2014 |
|---|---|
| 구분 : | 학위논문 |
| 학술지명 : | |
| 관련링크 : | http://www.riss.kr/link?id=T13556071 |
- 기타서명
Application of Quality by Design in pharmaceutical quality assurance system
- 저자
이혜민
- 형태사항
vii, 56 p. ; 26 cm.
- 일반주기
충북대학교 논문은 저작권에 의해 보호됩니다
지도교수 :홍진태
참고문헌 (53-54 p.) 수록 - 학위논문사항
학위논문(석사)-- 충북대학교 일반대학원 : 약학과(원) 2014. 8
- KDC
518.44 5
- 발행국
충청북도
- 언어
한국어
- 출판년
2014
- 소장기관
- 충북대학교 도서관
- 충북대학교 도서관
- 초록 (Abstract)
- In this study, “Quality by Design (QbD)”system was investigated as a current GMP upgrade trend in the Korean pharmaceutical industry. Furthermore, it was included on the fundamentals based on the introduction of QbD, implementation process, current status in foreign pharmaceutical advanced countries, and comparative study of pharmaceutical quality assurance system between conventional approach and QbD based approach. Guidelines, implementation process and current status in foreign pharmaceutical advanced countries were investigated on the FDA, ICH (ICH Q8 R2), and EMA. In manufacturing process of solid oral dosage forms, the qualitative and financial differences between conventional approach and QbD based approach were studied by predictive modeling method. Investigating the precedential QbD implementation in the pharmaceutical advanced countries, for the advance in pharmaceutical quality assurance system, the QbD would improve the efficiency and flexibility of the manufacturing process while maintaining the high quality of pharmaceuticals products. As the results of predictive case study in the solid oral dosage forms, the conventional approach had a tendency to guarantee quality of pharmaceutical products by restricting various process parameters through the manufacturing process validation. It was just to focus on the optimization and reproducibility of the manufacturing process. Meanwhile, the QbD based approach could guarantee the quality by the flexible and efficient methods centered at robustness, based on understanding of pharmaceutical products and processes. In detail, QbD based approaches could enhance productivity through shortening of process time related to the conventional approach and could manage the risk assessments through a design space into the correlation between content uniformity and processing time in the mixing unit process, and the correlation between moisture content and processing time in the drying unit process. The study presents QbD based approach could make the essential benefits in terms of pharmaceutical regulatory affair, drug development, manufacturing process, quality control and assurance system. Therefore it suggests the implementation of QbD should be acted in the Korean pharmaceutical industry through the social consultation with the Korean regulatory authorities and pharmaceutical companies.
- 목차 (Table of Contents)
- Ⅰ. 서 론 1
- 1. GMP제도 도입배경 1
- 2. QbD제도 도입의 국내 및 국외현황 6
- 3. 연구 목적 11
- Ⅱ. 방 법 12
- 1. FDA, ICH, EMA 품질지침 자료조사 12
- 2. 국내외 기존 연구결과 문헌조사 12
- 3. 위험평가 및 실험설계 분석 12
- 4. 공정능력지수 및 공정능력 분석 13
- Ⅲ. 결 과 14
- 1. FDA, ICH, EMA 품질지침 분석 14
- 2. QbD방식의 일반적인 단계 및 현행방식과 QbD방식 비교 25
- 3. 고형제 제조공정에서 현행방식과 QbD방식 비교 32
- 4. 현행방식과 QbD방식 Benefit 비교 43
- Ⅳ. 고 찰 49
- Ⅴ. 결 론 52
- Ⅵ. 참고문헌 53
- Ⅶ. 영문요약(초록) 55
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