1 一般强制执行规章 GENERAL ENFORCEMENT REGULATIONS 2 一般行政规则与决定 GENERAL ADMINISTRATIVE RULINGS AND DECISIONS 3 产品管辖权 PRODUCT JURISDICTION 5 组织ORGANIZATION 7 强制执行政策 ENFORCEMENT POLICY 10 行政规范与程序 ADMINISTRATIVE PRACTICES AND PROCEDURES 11 电子化记录;电子化签名 ELECTRONIC RECORDS; ...
内容提示: TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION PART 111--CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Subpart A--...
Health Association Petitions FDA to Amend Dietary Supplements cGMP RegulationsAsebey, Edgar
4.要点4.1cGMP的目的2008年Preamble第I部分Background的第一句:“SincethedevelopmentoftheCGMPregulationsfordrugproductsin1962,FDAhasbalancedtheneedforeasilyunderstoodminimumstandardswiththeneedtoencourageinnovationandthedevelopmentofimprovedmanufacturingtechnologies.”。我在文献10也指出:“GMP是法律化的药品生产企业基本...
§111.5-Dootherstatutoryprovisionsandregulationsapply?SubpartB--Personnel§111.8-WhataretherequirementsunderthissubpartBforwrittenprocedures?§111.10-Whatrequirementsapplyforpreventingmicrobialcontaminationfromsickorinfectedpersonnelandforhygienicpractices?§111.12-Whatpersonnelqualificationrequirementsapply?§111.13-What...
文献5：Dietary Supplement Health and Education Act of 1994，美国国会颁布的管理膳食 补充剂的法律，下文简称DSHEA 文献6：Guidance for Industry, Quality System Approach to Pharmaceutical cGMP Regulation ，FDA 关于质量系统的指南。文献7：Guidance for Industry, Part 11, Electronic Records; Electronic Signatures...
The cGMP audit is based on chapter 8 of the NSF/ANSI 173 standard, which is the only national standard for the dietary supplement industry in the United States. This standard meets the requirements of FDA GMP and FSMA regulations. The NSF-cGMP audit of dietary supplements (health food) has...
概述:美国《联邦规章典集》(Code of Federal Regulations,CFR)第21篇“食品与药品”(Title 21―Food and Drugs)共有9卷(Volume)、3章(Chapter)、1499部(Parts)。其中:第1―8卷第1章第1―1299部,为健康与人类服务部食品与药品管理局(Food and Drug Administration,Department of Health and Human Services)的...
This paper aims to study five of the major GMP regulations for herbal products adopted in different countries and regions and determine the differences in terms of principles, contents, supervision, and industrial influence. The GMP standard selected for this study include the WHO-GMP, GMP in ...
§ 111.5 - Do other statutory provisions and regulations apply? Subpart B--Personnel § 111.8 - What are the requirements under this subpart B for written procedures? § 111.10 - What requirements apply for preventing microbial contamination from sick or infected personnel and for hygienic practice...