의료 기기 Gmp 종합 해설서 | [아고라스쿨] 의료기기의 Gmp 적합인정 프로세스 15229 명이 이 답변을 좋아했습니다

당신은 주제를 찾고 있습니까 “의료 기기 gmp 종합 해설서 – [아고라스쿨] 의료기기의 GMP 적합인정 프로세스“? 다음 카테고리의 웹사이트 you.maxfit.vn 에서 귀하의 모든 질문에 답변해 드립니다: you.maxfit.vn/blog. 바로 아래에서 답을 찾을 수 있습니다. 작성자 보건산업혁신창업센터 KBIC 이(가) 작성한 기사에는 조회수 1,294회 및 좋아요 28개 개의 좋아요가 있습니다.

의료 기기 gmp 종합 해설서 주제에 대한 동영상 보기

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우리나라에서 진행하고 있는 GMP 적합인정 프로세스에 대해서
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#의료기기 #GMP #적합인정

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[식품의약품안전처] 의료기기 GMP 종합 해설서(민원인 안내서 …

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의료기기 GMP 제도는 의료기기의 설계·개발, 생산, 시판 후 관리 등 전 과정에 대한 품질경영시스템의 확보를 통해 안전(safe)하고, 유효(effective) …

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주제와 관련된 이미지 의료 기기 gmp 종합 해설서

주제와 관련된 더 많은 사진을 참조하십시오 [아고라스쿨] 의료기기의 GMP 적합인정 프로세스. 댓글에서 더 많은 관련 이미지를 보거나 필요한 경우 더 많은 관련 기사를 볼 수 있습니다.

주제에 대한 기사 평가 의료 기기 gmp 종합 해설서

Author: 보건산업혁신창업센터 KBIC
Views: 조회수 1,294회
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Date Published: 2022. 2. 23.
Video Url link: https://www.youtube.com/watch?v=btfA0M5rR2I

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의료기기 GMP 종합 해설서 (민원인 안내서)
[목 차]
의료기기 제조 및 품질관리 기준

용어의 정의

의료기기 적합성인정등 기준

의료기기 제조 및 품질관리 기준

제1조(목적)

기준

이 기준은 「의료기기법」 제6조제4항, 제6조의2제4항, 제10조제2항, 제12조제4항, 제13조제1항, 제15조제6항, 제28조, 제45조 및 「의료기기법 시행규칙」제8조 제1항, 제14조제1항제1호, 제24조제1항제10호, 제26조제1항 및 제3항, 제27조 제1항제10호·제11호, 제31조제1항, 제33조제1항제15호, 제48조, 별표 2, 별표 4 와 「의료기기산업 육성 및 혁신의료기기 지원법」제24조제9항 및 「혁신의료기기 지원 등에 관한 규칙」제15조에 따라 의료기기(임상시험용 의료기기 포함한다)를 제조 또는 수입함에 있어 준수하여야 하는 세부사항과 품질관리심사기관 및 품질책임자 교육실시기관에 대한 지정절차 및 관리방법 등에 관하여 필요한 사항을 정함을 목적으로 한다.

□ 관련법령

○ 의료기기법 – 제6조(제조업의 허가 등) ④ 제1항에 따라 제조업허가를 받으려는 자 및 제2항에 따라 제조허가 또는 제조인증을 받거나 제조신고를 하려는 자는 총리령으로 정하는 바에 따라 필요한 시설과 제조 및 품질관리체계를 미리 갖추어 허가 또는 인증을 신청하거나 신고 하여야 한다. 다만, 품질관리를 위한 시험이나 제조공정을 위탁하는 등 총리령으로 정 하는 경우에는 그러하지 아니하다. – 제6조의2(품질책임자 준수사항 등) ① 제6조제7항에 따른 품질책임자(이하 “품질책임자”라 한다)는 의료기기의 제조업무에 종사하는 종업원에 대한 지도·감독, 제조관리·품질관리· 안전관리(시판 후 부작용 등에 대한 안전관리를 포함한다. 이하 이 조에서 같다) 업무를 수행한다. ② 품질책임자는 의료기기의 최신 기준규격, 품질관리 및 안전관리에 관한 교육을 매년 1회 이상 정기적으로 받아야 한다. ③ 식품의약품안전처장은 국민건강의 위해를 방지하기 위하여 필요한 경우 품질책임자에게 제2항에 따른 교육을 매년 1회 이상 정기적으로 받는 것 외에 추가로 받을 것을 명할 수 있다. ④ 제1항부터 제3항까지에서 규정한 사항 외에 직무범위, 교육내용·시간·방법과 절차, 교육비, 교육실시기관의 지정 등에 필요한 사항은 총리령으로 정한다. – 제10조(임상시험계획의 승인 등) ② 제1항에 따라 승인을 받은 임상시험용 의료기기를 제조· 수입하려는 자는 총리령으로 정하는 기준을 갖춘 제조시설에서 제조하거나 제조된 의료기기를 수입하여야 한다. 이 경우 제6조제2항 및 제15조제2항에도 불구하고 허가 또는 인증을 받지 아니하거나 신고를 하지 아니하고 이를 제조하거나 수입할 수 있다. – 제12조(변경허가 등) ④ 제1항에 따른 변경허가, 변경인증 또는 변경신고의 절차 및 기준 등에 관하여 필요한 사항은 총리령으로 정한다. – 제13조(제조업자의 의무) ① 제조업자는 시설 및 품질관리체계를 유지하여야 하며, 그 밖에 제조 및 품질관리(자가시험을 포함한다) 또는 생산관리에 관하여 총리령으로 정하는 사항을 지켜야 한다. – 제15조(수입업 허가 등) ⑥ 수입 의료기기 또는 그 수입업자에 대하여는 제조 관련 조항을 준용한다. – 제28조(품질관리심사기관의 지정 등) : 식품의약품안전처장은 품질심사를 수행할 기관인 품질관리심사기관을 지정할 수 있으며, 지정요건과 그 절차 방법 등에 관하여 필요한 사항은 총리령으로 정한다. – 제45조(자료제출의 보호) : ① 식품의약품안전처장은 제6조부터 제10조까지, 제11조, 제12조 또는 제15조에 따라 자료를 제출한 자가 자료의 보호를 문서로 요청하면 그 제출된 자료를 공개하여서는 아니 된다. 다만, 공익상 자료를 공개할 필요가 있다고 인정한 경우에는 자료를 공개할 수 있다. ② 제1항에 따라 보호를 요청한 제출 자료를 열람·검토한 자는 그 내용을 외부에 공개하여서는 아니 된다.

의료기기 GMP 종합해설서 2021 – 교보문고

상품상세정보 ISBN 9791129025319 ( 1129025314 ) 쪽수 370쪽 크기 182 * 257 mm 판형알림

책소개

이 책이 속한 분야

의료기기 GMP 제도는 의료기기의 설계·개발, 생산, 시판 후 관리 등 전 과정에 대한 품질경영시스템의 확보를 통해 안전(safe)하고, 유효(effective)하며, 의도된 용도(intended use)에 적합한 품질의 제품을 일관성 있게(consistently) 제조·판매됨을 보장할 수 있는 최소한의 요구조건이다.

의료기기는 사람의 생명 또는 건강에 직·간접적으로 영향을 미치는 제품으로 그 특성 때문에 높은 수준의 품질관리가 필요하다. 따라서 다음의 사항들을 종합적으로 고려하여야 한다.

– 작업자나 관리자가 일으키는 착오, 혼동 등 실수 최소화

– 세균이나 이물질에 의해 의료기기 오염방지

– 검증되지 않은 원자재 사용 방지 및 공정변수로 인한 품질변화 최소화

– 일정수준 이상의 품질을 보증할 수 있는 체계 유지

목차

의료기기 제조 및 품질관리기준

제1조 목적

제2조 정의

제3조 적용범위

제4조 적합성인정 등 심사 구분

제5조 적합성인정 등 심사 기준

제6조 적합성인정 등 심사 방법

제7조 적합성인정 등 심사 신청

제8조 적합성인정 등 심사 절차

제9조 적합인정서 유효기간

제10조 적합성인정서 재발급 등

제10조의2 적합인정서 반납

제11조 적합성인정 등 심사 표시

제12조 품질관리심사기관 업무

제13조 품질관리심사기관 지정 평가

제14조 품질관리심사기관 관리운영기준 등

제15조 보고

제16조 품질관리심사기관에 대한 지도·점검 등

제17조 품질책임자 교육실시기관 지정 신청

제18조 품질책임자 교육실시기관 지정 평가

제19조 품질책임자 교육실시기관 지정 공고

제20조 교육내용

제21조 품질책임자 교육실시기관장의 준수사항 등

제22조 품질책임자 교육실시기관에 대한 지도·점검 등

제23조 규제의 재검토
[별표 1] 용어의 정의
[별표 2] 의료기기 적합성인정 등 기준

1. 목 적

2. 적용범위

3. 용어의 정의

4. 품질경영시스템

5. 경영책임

6. 자원관리

7. 제품실현

8. 측정, 분석 및 개선

9. 의료기기 적합성인정 등 심사표
[별표 3] 의료기기 GMP 품목군
[별표 4] 적합성인정 등 심사 주체
[별표 5] 적합인정서 발급 및 관리
[별표 6] 적합성인정 등 표시
[별표 7] 의료기기 품질관리심사기관 평가기준
[별표 8] 의료기기 품질관리심사기관 관리운영기준
[별표 9] 품질책임자 교육실시기관의 지정 기준

참고문헌

의료기기 GMP 종합 해설서(5개정) 개정

의료기기 제조 및 품질관리기준 ····························································· 1 제 1조 목적 ····································································································· 3 제 2조 정의 ··································································································· 11 제 3조 적용범위 ··························································································· 12 제 4조 적합성인정등 심사 구분 ······························································· 15 제 5조 적합성인정등 심사 기준 ······························································· 17 제 6조 적합성인정등 심사 방법 ······························································· 19 제 7조 적합성인정등 심사 신청 ······························································· 30 제 8조 적합성인정등 심사 절차 ······························································· 76 제 9조 적합인정서 유효기간 ····································································· 88 제10조 적합성인정서 재발급 등 ······························································· 89 제10조의2 적합인정서 반납 ······································································ 92 제11조 적합성인정등 심사 표시 ······························································· 94 제12조 품질관리심사기관 업무 ································································· 95 제13조 품질관리심사기관 지정 평가 ······················································· 96 제14조 품질관리심사기관 관리운영기준 등 ··········································· 97 제15조 보고 ··································································································· 99 제16조 품질관리심사기관에 대한 지도․점검 등 ·································· 100 제17조 품질책임자 교육실시기관 지정 신청 ······································ 101 제18조 품질책임자 교육실시기관 지정 평가 ······································ 102 제19조 품질책임자 교육실시기관 지정 공고 ······································ 103 제20조 교육내용 ························································································ 103

제21조 품질책임자 교육실시기관장의 준수사항 등 ·························· 104 제22조 품질책임자 교육실시기관에 대한 지도․점검 등 ·················· 105 제23조 규제의 재검토 ············································································ 106 [별표 1] 용어의 정의 ··············································································· 107 [별표 2] 의료기기 적합성인정등 기준 ················································· 115 1. 목 적 ································································································· 117 2. 적용범위 ····························································································· 118 3. 용어의 정의 ······················································································· 119 4. 품질경영시스템 ··················································································· 119 4.1 일반 요구사항 ················································································· 119 4.2 문서화 요구사항 ············································································· 133 5. 경영책임 ······························································································· 149 5.1 경영의지 ··························································································· 149 5.2 고객중심 ··························································································· 151 5.3 품질방침 ··························································································· 152 5.4 기획 ··································································································· 154 5.5 책임, 권한 및 의사소통 ································································ 157 5.6 경영검토 ··························································································· 161

6. 자원관리 ······························································································· 166 6.1 자원의 확보 ····················································································· 166 6.2 인적자원 ··························································································· 167 6.3 기반시설 ··························································································· 170 6.4 작업환경과 오염관리 ····································································· 172 7. 제품실현 ······························································································· 178 7.1 제품실현의 기획 ············································································· 178 7.2 고객 관련 프로세스 ······································································· 181 7.3 설계 및 개발 ··················································································· 185 7.4 구매 ··································································································· 212 7.5 생산 및 서비스 제공 ······································································ 222 7.6 모니터링 및 측정 장비의 관리 ···················································· 248 8. 측정, 분석 및 개선 ············································································ 251 8.1 일반 요구사항 ················································································· 251 8.2 모니터링 및 측정 ··········································································· 255 8.3 부적합 제품의 관리 ······································································· 269 8.4 데이터의 분석 ················································································· 277 8.5 개선 ··································································································· 282 9. 의료기기 적합성인정등 심사표 ······················································· 293
[별표 3] 의료기기 GMP 품목군 ···························································· 313 [별표 4] 적합성인정등 심사 주체 ························································· 321 [별표 5] 적합인정서 발급 및 관리 ······················································· 325 [별표 6] 적합성인정등 표시 ··································································· 329 [별표 7] 의료기기 품질관리심사기관 평가기준 ································· 333 [별표 8] 의료기기 품질관리심사기관 관리운영기준 ························· 341 [별표 9] 품질책임자 교육실시기관의 지정 기준 ······························· 351 ≪참고문헌≫ ································································································· 367