임상시험용의약품 보관조건
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2018 FAQ(의약품분야)
Q 34
저희 기관에는 임상약 보관실(실온) 안에 실온 보관장 3개, 냉장고 2개를 보유하고
있으며 임상약 보관실은 항상 열쇠로 잠그고 관리약사가 열쇠를 관리하고 있습니다.
① 보관실을 열쇠로 잠그면 보관장, 냉장고에 별도의 잠금장치를 하지 않아도 되는지요?
② 실온 보관장의 경우 보관장마다 별도로 온도를 측정해야 하는지, 보관실 내 온도만 측정하면 되는지요?
A: 2015년 임상시험 관련 자주 묻는 질의·응답집’에서 안내하는 바와 같이 임상시험용 의약품은 관리약사에 의해 관리되어야 하며, 관리약사만이 출입 가능한 임상
약국의 경우, 출입문에 잠금장치가 설치되어 있고 열쇠관리를 관리약사만이 하고 있다면, 냉장고, 냉동고 등 보관시설에 추가적인 잠금장치를 설치하지 않아도 될 것으로
사료됩니다.
임상시험용의약품 보관실 내부에 설치한 온도계의 위치가 전체 보관구역(보관장 포함)에 대표성을 가지는 경우라면, 보관장별로 별도로 온도를 관리할 필요는 없을 것으로
사료됩니다.
- 참고로 임상시험용의약품의 보관은「의약품 등의 안전에 관한 규칙」[별표 4]제7호바목5)에 “의뢰자가 지정한 조건과 관계 법령에 따라 보관하여야 한다.”고
규정되어 있음을 알려드립니다.
- 이전글원자재 공급업체에 대한 실사 20.05.20
- 다음글컴퓨터화시스템밸리데이션의 적용범위는 PICS규정 내 에서 회사마다 다르게 정할 수 있다 20.05.20
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