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2022.11.24

의약품 제조업체 데이터 완전성(DI) 평가 지침 관련 행정 지시 안내

- 의약품 제조업체 데이터 완전성(DI) 평가 지침 관련 행정 지시 안내

2023년 1월 1일부터 모든 의약품 및 원료의약품 제조업체에 데이터완전성(Data Integrity, DI) 평가 지침의 모든 내용을 적용됩니다.
첨부드린 공문 및 붙임1,2 파일 참조 부탁드립니다.

- 첨부 -
1) [공문] '의약품 제조업체 데이터 완전성 평가 지침' 관련 행정 지시
2) [붙임1] 품목별 사전 GMP 평가 시 데이터완전성 평가 제출자료
3) [붙임2] 의약품 제조업체 데이터 완전성 평가지침

- 영인크롬텍에서 공급하는 DI 평가 지침 충족 제품

SARTORIUS 정밀저울 CubisⅡ

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