<국내 제조소>
의약품 제조 및 품질관리기준(GMP)
정기약사감시 주요 보완사례(‘15~’17)(Ⅱ)
2017. 12.
의약품안전국 의약품관리과
목 차
1. 의약품 제조소(GMP) 정기감시 현황 ················· 4
2. 주요 지적사례
Ⅰ. 시설관리 ·············································································· 5
Ⅱ. 환경관리 ············································································ 6
Ⅲ. 조직 ···················································································· 7
Ⅳ. 기준서 ················································································ 8
Ⅴ. 문서 ···················································································· 9
Ⅵ. 밸리데이션 ········································································ 10
Ⅶ. 품질관리 ············································································ 11
Ⅷ. 제조관리 ············································································ 12
Ⅵ. 기타 ···················································································· 13
1 의약품 제조소(GMP) 정기감시 현황
Ⅰ. 감시 개요
식약처는 의약품 제조단계에서의 품질 위해 최소화를 위해 국내 모든
의약품 제조소를 대상으로 정기 현장감시를 실시하고 있습니다.
특히 2014년 7월 의약품실사상호협력기구(PIC/S) 가입으로 3년 유효
기간의 제조 및 품질관리기준(GMP) 적합판정서 발급을 위해 완제 및 원료
의약품 제조소에 대해서는 2015년부터 3년 주기의 정기감시와 GMP 적합
판정 평가를 연계하여 실시하고 있습니다.
www.seoho.biz
㈜서호 전북 전주시 덕진구 혁신로 586 (54851)
Tel. 063-214-9325 / Fax. 063-214-9328
