美国cGMP-中英文对照VIP专享

PART 210 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL210 部分 有关于生产、加工、包装和药品的储存的现行 GMP；一般准则Sec 。 210.1 Status of current good manufacturing practice regulations.210.1 cGMP 的法规地位。（a) The regulations set forth in this part and in parts 211 through 226 of this chapter contain the minimum current good manufacturing practice for methods to be used in， and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug to assure that such drug meets the requirements of the act as to safety ， and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess.(a)在本部分及本章第 211－226 部分中所陈述的法规,为现行 GMP 最低要求，适用于药品制造、加工、包装或贮存中所采纳的方法及所使用的设施或控制手段,以保证该药品符合《联邦食品、药品及化妆品法案》（以下简称法案）对安全性的要求，具有均一性和效价（或含量)并符合或代表其生产过程的质量及纯度等特征。（b) The failure to comply with any regulation set forth in this part and in parts 211 through 226 of this chapter in the manufacture ， processing, packing ， or holding of a drug shall render such drug to be adulterated under section 501（a） (2）（B) of the act and such drug， as well as the person who is responsible for the failure to comply ， shall be subject to regulatory action。（b)凡是在药品生产、加工、包装或贮存过程中存在任何不符合本部分及 21CFR 211-226部分中陈述的法规的药品，依据联邦食品、药品及化妆品法 501 (a）(2）—（B），该药应被视为劣药，同时导致该事故发生的负责人应受相应的法规的制裁。（c） Owners and operators of establishments engaged in the recovery, donor screening ， testing (including donor testing), processing, storage ...