21CFRPart210-211,orCurrentGoodManufacturingPractices(CGMP)inManufacturing,Process- ing,PackingorHoldingofDrugs(210);CGMPforFinishedPharmaceuticals(211),requirethatall drugsarecompliantwiththelatestGMPs.Theregulationsensurethatdrugproductsmeetregulatory requirementsastosafety,strength,qualityandpurity. ...
内容提示: 21 CFR PARTS 210 & 211; Revised as of April 1st 1997 Page 1 of 24 RECORDS_SIGS GMP.doc PART 210-CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL ...3 §210.1 Status of current good manufacturing practice regulations......
PART210CURRENTGOODMANUFACTURINGPRACTICEIN MANUFACTURING,PROCESSING,PACKING,OR HOLDINGOFDRUGS;GENERAL Sec.210.1Statusofcurrentgoodmanufacturingpracticeregulations. (a)Theregulationssetforthinthispartandinparts211through226ofthischaptercontaintheminimumcurrentgoodmanufacturingpracticeformethodstobeusedin,andthefacilitiesorco...
(a) The regulations in this part and in Parts 211 through 226 of this chapter as 210210 部分部分——人用及兽用药品的生产、加人用及兽用药品的生产、加工、包装或贮存的工、包装或贮存的 cGMPcGMP 210.1 cGMP 法规的地位 210.2 cGMP 法规的适用性 210.3 定义 210.1 cGMP210.1 cGMP 法规的地位法规的...
21CFR Part 210&211 中英文对照版_2020.4 PART210 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING,PROCESSING,PACKING, OR HOLDING OF DRUGS;GENERAL 210部分 人用及兽用药品的生产、包装或储存的现行药品生产质量管理规范 （通则）第1页共72页
21 Code of Federal Regulations Parts 210 and 211 Part 210 - CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL PART 211 ? - CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS 210部分—人用及兽用药品的生产、加工、包装或贮存的CGMP(概...
and control principles to drug manufacturing. The word "current" was later added to make it "CGMP" (or cGMP) to imply that the regulation allows for changing technology in attaining GMP. Learn howMasterControl's Quality Excellencecan help your compliance efforts to FDA 21 CFR Part 210-211. ...
21CFR210中英文对照版(SMART).pdf,Part 210 - CURRENT GOOD MANUFACTURING 210 部分— 人用及兽用药 品的生产 、加工、包装或贮存 的 PRACTICE IN MANUFACTURING, PROCESSING, CGMP PACKING, OR HOLDING OF DRUGS; GENERAL 210.1 Status of current good manufacturing prac
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21CFR PART210&211 中英文对照版 网络上找到的，我对格式做了修改 阅读起来更流畅