위험관리 기법을 이용한 무균의약품 제조소 Contamination Control Strategy 수립 방안 연구

• 영문명: Study of Establishing a Contamination Control Strategy using a Quality Risk Management for Manufacture of Sterile Products
• 발행기관: 대한약학회
• 저자명: 이상재(Sangjae Lee) 정재호(Jaeho Jung) 신민영(Minyeong Shin) 장인택(Intaek Jang) 김태규(Taekyu Kim)
• 간행물 정보: 『약학회지』제65권 6호, 432~440쪽, 전체 9쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2021.12.31

영문 초록

Manufacturers engaging in Good Manufacturing Practice (GMP) for a sterile product are required to establish a Contamination Control Strategy (CCS) to prevent product contamination. Domestic and overseas regulations including the EU GMP Guideline “Annex.1 Manufacture of Sterile Products” mention the importance of establishing a CCS; however, despite mentioning a risk management method, the Annex does not describe a specific implementation method. Sterile product manufacturers should take measures to prevent product contamination by establishing an appropriate CCS. Therefore, this study presents a method for establishing a CCS strategy, as required by various guidelines, using the quality risk management method presented in ICH Guideline Q9. In this study, when establishing a CCS strategy by applying the quality risk management method, it was possible to confirm factors affecting product contamination through Cause and Effect Analysis, and the degree to which each factor influences product contamination through Failure Mode and Effect Analysis. Based on these results, when establishing product contamination countermeasures, manufacturers can identify the items requiring improvement and evaluate the strength of these measures. Finally, the manufacturers can establish a CCS at the level required by the relevant guidelines. This study is meaningful in providing a method for establishing a CCS that can be applied by sterile product manufacturers in the future by presenting a CCS using the quality risk management method.

목차

서 론(Introduction)

방 법(Methods)

결과 및 고찰(Results and Discussion)

결 론(Conclusion)

References

키워드

Contamination control strategy (CCS) Quality risk management (QRM) GMP FMEA Sterile product