21CFR211中英文对照版(SMART)PART 211 211部分 - CURRENT GOOD MANUFACTURING PRACTICE FOR —制剂药品的CGMP FINISHED PHARMACEUTICALS Subpart A--General Provisions A.总 则 §211.1 - Scope.211∙1范围 §211.3 - Definitions.211∙3定义 Subpart B--Organization and Personnel B．组织与人员 ...
PART 211 211部分 - CURRENT GOOD MANUFACTURING PRACTICE FOR —制剂药品的CGMP FINISHED PHARMACEUTICALS Subpart A--General Provisions § - Scope. 211∙1范围 § - Definitions. 211∙3定义 Subpart B--Organization and Personnel § - Responsibilities of quality control unit. 211∙22质量控制部门的职...
21CFR211中英文对照版(SMART) PART 211 211部分 - CURRENT GOOD MANUFACTURING PRACTICE FOR —制剂药品的CGMP FINISHED PHARMACEUTICALS Subpart A--General Provisions A.总 则 §211.1 - Scope. 211 ∙1范围 §211.3 - Definitions. 211 ∙3定义 Subpart B--Organization and Personnel B.组织与人员 §...
实验室控制系统(CGMP21CFR211分录I和K) 63 物料系统(CGMP21CFR211分录E和H) 72 说明:文件中绿色突出显示的内容是FDA2008年12月8日修订执行的新要求. 六大体系通用的法规分录B&J SubpartB--OrganizationandPersonnelB.组织与人员 Sec.211.22Responsibilitiesofqualitycontrolunit. 211∙22质量控制部门的职责 (a)Th...
[Title 21, Volume 4] [Revised as of April 1, 2010] [CITE: 21CFR211] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER C--DRUGS: GENERAL PART 211 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Subpart A--...
21-CFR-210&211-cGMP中英对照版(6532) 热度: TITLE21--FOODANDDRUGS CHAPTERI--FOODANDDRUGADMINISTRATION DEPARTMENTOFHEALTHANDHUMANSERVICES SUBCHAPTERB--FOODFORHUMANCONSUMPTION PART111--CURRENTGOODMANUFACTURINGPRACTICEIN MANUFACTURING,PACKAGING,LABELING,ORHOLDINGOPERATIONS ...
HYPERLINK /scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211showFR=1subpartNode=21:.10.2 Subpart B--Organization and Personnel HYPERLINK /scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=211.22 §211.22 - Responsibilities of quality control unit. HYPERLINK /scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm...
21CFR211中英文对照版(SMART) PART 211 211部分 - CURRENT GOOD MANUFACTURING PRACTICE FOR —制剂药品的CGMP FINISHED PHARMACEUTICALS Subpart A--General Provisions A.总 则 §211.1 - Scope. 211 ∙1范围 §211.3 - Definitions. 211 ∙3定义 Subpart B--Organization and Personnel B.组织与人员 §...
21 CFR Part 11法规是美国政府食品及药物管理局(FDA)制定的法规,它要求与产品生产有关的所有电子记录和签名、无纸记录以及报告程序必须在其控制下为商业目的而获取和存储,例如生物制药、食品和饮料工业等。这项法规要求能够受保护地、精确和快速地获取所有记录。安全的、由计算机生成的、带有时间标记的审计跟踪必须能够...
21 CFR Parts 210 and 211 Regulations Document Control Subpart F, Section 211.100 – There shall be written procedures for production and process control, assuring that drug products have the intended identity, strength, quality, and purity. Written procedures, including any changes, shall be drafted...