并且重新评估必须记录在案.如果您确定与从外国供应商进口食品相关的问题已经改变,您必须立即确定(并记录)继续从外国供应商进口食品是否合适,以及供应商验证活动是否根据§ 1.506进行或§ 1.511(c)需要更改。
Cofthischapter,orinpart1271subpartDofthischapterwithrespectto themanufacture,processing,packingorholdingofadrug,rendersanHCT/P adulteratedundersection501(a)(2)(B)oftheact.SuchHCT/P,aswellasthe personwhoisresponsibleforthefailuretocomply,issubjecttoregulatory ...
[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--...
As servicing is not required of all medical devices, this subpart of the regulations is one of the more commonly excluded regulations from an organization's quality system requirements.
Part 21 CFR 801 Subpart D问题补充:匿名 2013-05-23 12:21:38 部分21 CFR 801子部分D 匿名 2013-05-23 12:23:18 部分21CFR801subpart d 匿名 2013-05-23 12:24:58 第21部分CFR 801子部分D 匿名 2013-05-23 12:26:38 部分21 CFR 801 Subpart D 匿名 2013-05-23 12:28:18 ...
a莫言的《丰乳肥臀》彻底颠覆了“革命历史小说”。 Not said "Abundant Breast Fat Buttocks" to subvert “the revolution historical novel” thoroughly.[translate] aPart 21 CFR 801 Subpart D 第21部分CFR 801子部分D[translate]
license application under section 351 of the Public Health Service Act) are subject to this part and are also subject to the donor-eligibility procedures set forth in part 1271 subpart C of this chapter and applicable current good tissue practice procedures in part 1271 subpart D of this ...
理解21 CFR Part 11 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...
美国FDA-21CFR820法规(详细)英文版.pdf,SUBCHAPTER H--MEDICAL DEVICES PART 820 QUALITY SYSTEM REGULATION Subpart A--General Provisions § 820.1 - Scope. § 820.3 - Definitions. § 820.5 - Quality system. Subpart B--Quality System Requirements § 820.20 - Ma