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 ...
in this part unless the regulations ex- plicitly provide otherwise. In the event it is impossible to comply with applica- ble regulations both in this part and in other parts of this chapter or in parts 600 through 680 of this chapter, the reg- ulation specifically applicable to the drug...
toadrugandinParts600through680ofthis chapterastheymaypertaintoabiological productforhumanuse,shallbeconsideredto supplement,notsupersede,eachother,unless theregulationsexplicitlyprovideotherwise.In theeventthatitisimpossibletocomplywithall applicableregulationsintheseparts,the ...
美国联邦法规(CFR)第21篇“食品与药品”总目录.pdf,美国联邦法规(CFR)第21 篇“食品与药品”总目录 概述:《美国联邦法规》(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
The article reports an increase in offers for imported plate into India by 30 U.S. dollars to 680 U.S. dollars to 690 U.S. dollars per tonne cost and freight (cfr) Mumbai for October-November 2010 shipments.NairSureshEBSCO_bspMetal Bulletin Daily...
In the event of a conflict between applicable regulations in this part and in other parts of this chapter, or in parts 600 through 680 of this chapter, or in part 1271 of this chapter, the regulation specifically applicable to the drug product in question shall supersede the more general. ...
to the regulations in this part and in Parts 211 through 226 and Parts 600 through 680 of this chapter, and not in others, that person need only comply with those regulations applicable to the operations in which he or (b) 如果一个人只参与本处法规和211至226和600至680所要求的某些操，且...
applicabletothedruginquestionshallsupersedethe l (a)本部分及21CFR211—226适用于普通药品,21CFR600 —680适用于人用生物制品,除非另有明确规定,否则上述 两者之间应该是相互补充而不是相互取代。如有上述两部 分的法规不适用的药品,则可用特定的具体法规来替代。
(a) The regulations in this part and in Parts 211 through 226 of this chapter as they may pertain to a drug and in Parts 600 through 680 of this chapter as they may pertain (a) 本部分及21CFR 211—226适用于普通药品,21CFR 600 to a biological product for human use, shall be —680...
is impossible to comply with applicable regulations both in this part and in other parts of this chapter or in parts 600 through 680 of this chapter, the regulation specifically applicable to the drug product in question (c) Pending consideration of a proposed exemption, published in the Federal...