Earticle

초록

영어

Packaging process is a special process under the definition of GMP. That is, it shall be managed specially since the state of sterilization and product cannot be checked completely in the following inspection or test after packaging. The special management like this shall be started from the validation. Recently in case of the sterile product, the importance of packaging work process which maintains sterility and protects products together with the sterilization process is being highlighted. However, it is urgent to conduct a study on the guideline which can evaluate the safety and validity of packaging process since it is the actual situation in Korea not only that there is no guideline possible to evaluate the safety and validity of packaging process, but also that there is no practice case which is known widely. Therefore, we would like to develop the guideline which can be utilized at the site by reinterpreting current status on standards and studies in relation to the packaging at home and abroad through this study. Packaging validation may be referred to as the work checking the feasibility for the packed final product whether the process, facility or system functions properly as it was intended to with the objective evidence. This report would like to present practice cases such as various data analyses to perform the IQ (installation qualification), OQ (operation qualification), PQ (performance qualification) and packaging validation. The final objective of this research task is to build the guideline to packaging validation of medical devices which coincides with international standards and to reflect it to the screening and evaluation, etc. for the advancement in GMP operation of the medical device manufacturer. It is expected that the technological level of medical device manufacturer on GMP operation will be enhanced by preparing the guideline to packaging validation and practice standards through this study, and that it will contribute not only to the development of medical device industry, but also to the securement of health and safety of our people.

목차

초록
 I. 서론
 II. 본론
  1. 포장 시스템에 대한 설계 및 개발 요구사항
  2. 포장의 핵심요건
  3. 포장재의 선택
  4. 포장방법
  5. 포장 밸리데이션
  6. 포장 밸리데이션 Flow Chart
 III. 결론
 감사의 말
 참고문헌
 Abstract

키워드

저자

• 황원구 [ Won Koo Hwang | 한국건설생활환경시험연구원 바이오융합연구소 의료기기센터 ]
• 강규일 [ Gyoo Il Kang | 한국건설생활환경시험연구원 바이오융합연구소 의료기기센터 ]
• 송문용 [ Moon Yong Song | 한국건설생활환경시험연구원 바이오융합연구소 의료기기센터 ]
• 홍수연 [ Soo Youn Hong | 한국건설생활환경시험연구원 바이오융합연구소 의료기기센터 ]
• 허수길 [ Su Gil Hur | 한국건설생활환경시험연구원 바이오융합연구소 의료기기센터 ] 교신저자
• 이원회 [ Won Hoi Lee | 한국건설생활환경시험연구원 바이오융합연구소 의료기기센터 ]
• 황선진 [ Sun Jin Hwang | 식품의약품안전평가원 의료기기연구과 ]
• 염태경 [ Tai Kyung Ryeom | 식품의약품안전평가원 의료기기연구과 ]

참고문헌

발행기관

간행물

표지보기 관심저널 등록

• 간행물명

  KFDC규제과학회지(구 FDC법제연구) [Regulatory Research on Food, Drug and Cosmetic]

• 간기

  반년간

• pISSN

  2799-8940

• 수록기간

  2006~2025

• 십진분류

  KDC 518 DDC 615