FDA-GMP培训全套资料

Qualification and Validationin厚料药生产中的确认与整证Active Pharmaceutical Ingredients Production第1部分Section 1导论IntroductionIntroduction导论Because Its produdts ane ntended for human consumpion,the因为药品是供人使用，制药工业是世界上规范最严的业务，harmaceuical indus当y i among到he most highly re9bedbusinesses lin the word All nations have some fomm of drug regullation所有国家都有药品规范的一些形式和相应的机构来实庙这种and comresponding bodies to erlorce that regulation.规范。.Here,It i the Stte Food and Drug Administration tht ensures-在中国是国际食品药品监管局(SFDA),保证符合中华人compliance with the Dnug Administration Law of the People's Republic民共和国的药品管理法of China.-在美国是食品药品监管著(FDA)n the Unted States,lt the U.S.Food and Drug AdministrarionHn Canada,t is the Tharapeuc Produdts Dredorate of the federal-在加拿大，是承邦卫生部所属的药品监管司(TPD)Vinistry of Healih