GMP관련자료

Atachment
첨부 '1'	화장품 중 미생물한도 가이드라인민원인 안내서.pdf,

< 차 례 >
I. 서론 ······················································ 1
II. 미생물시험 ·············································· 1
1. 용어정의 ························································ 1
2. 미생물시험에 사용되는 기구 및 기기 ······················ 2
3. 미생물성장에 영향을 주는 요인 ······························2
4. 화장품의 미생물한도 시험시 검체 채취방법 ················5
5. 멸균법 ·····························································5
III. 화장품의 미생물한도 기준 및 시험방법 ·················6
IV. 참고문헌 ·················································15

www.seoho.biz

㈜서호 전북 전주시 덕진구 혁신로 586 (54851)

Tel. 063-214-9325 / Fax. 063-214-9328

seoho@seoho.biz

List of Articles
번호	제목	최근 수정일	조회 수
공지	'의약품 제조업체 데이터 완전성 평가지침' 관련 행정지시 2022-03-23	2022.03.31	1024
공지	'의약품 제조업체 데이터 완전성(Data Integrity) 평가지침' 관련 행정지시 (2020.10.29)식품의약품안전처 1	2021.04.30	4270
공지	US FDA Office of Regulatory Affairs (ORA 품질 정책 사무국 (ORA) 품질 정책 연구소) Laboratory Manual of Quality Policies	2021.04.08	1286
공지	PIC/S GUIDE PE 011-1 1 June 2014 CHAPTER 3 3.4 EQUIPMENT Calibration / alarm systems	2022.02.09	686
73	20170531_완제의약품 제조 및 품질관리기준(GMP) 가이던스(민원인 안내서)(제2개정)	2018.09.21	1313
72	2020년도 GMP 정책설명회 및 QbD 워크숍 발표 자료 총리령 및 고시 주요 개정 사항 안내	2021.06.29	38786
71	2021년도 GMP 정책설명회 및 QbD 워크숍 발표자료	2022.07.06	100
70	21 Cfr Part 11에 대한 NewFDA 지침- »타임 스탬프«	2021.03.16	2131
69	CFR - Code of Federal Regulations Title 21CFR211	2018.08.07	2305
68	Data Integrity and Compliance with cGMP –Guidance for Industry FDA–April 2016	2018.08.07	4301
67	Data-Integrity-in-Pharmaceutical	2018.08.07	4885
66	EN285 온도 허용오차 제시 LOOP CALIBRATION 50 °C to 150 °C, 1% (6.2.1.3 d)	2021.07.02	2869
65	Food and Drug Administration (Table 2. Equipment Calibration or Verification Requirements )	2020.05.08	314
64	GAMP 5 Guide: Compliant GxP Computerized Systems 1	2021.09.01	36481
63	GAMP® Good Practice Guide: Supplier Selection	2023.03.31	138

공지

'의약품 제조업체 데이터 완전성 평가지침' 관련 행정지시 2022-03-23 file