theproduct, production process, quality controls, equipment, facilities, orlabeling) established in an approved application beyond the variations alreadyprovided for in the application. The reporting category for such changesdepends on the potential to...
102 非标准化食品的普通的或者通常的名称 COMMON OR USUAL NAME FOR NONSTANDARDIZED FOODS 104 食品的营养质量指南 NUTRITIONAL QUALITY GUIDELINES FOR FOODS 105 特殊膳食用途的食品 FOODS FOR SPECIAL DIETARY USE 106 婴儿配方母乳替代食品质量控制程序 INFANT FORMULA QUALITY CONTROL PROCEDURES 107 婴儿配方母乳替代...
PACKAGING COMPONENTS包装组件的合格要求以及质量控制 Introduction介绍 GeneralConsiderations通常要求 InformationThatShouldBeSubmittedinSupportofanOriginalApplicationforAnyDrugProduct为支持任何药品的原始申请所必须提供的信息 InhalationDrugProducts吸入性药品 DrugProductsforInjectionandOphthalmicDrugProducts注射剂和眼科用药 Liquid...
FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES 第 B 分章一用于人类消费的食品(SUBCHAPTER—:00D FOR HUMAN CONSUMPTION ) 总则 GENERAL 食品标识 FOOD LABELING 非标准化食品的普通的或者通常的名称 COMMON OR USUAL NAME FOR NONSTANDARDIZED FOODS 食品的营养质量指南 NUTRITIONAL QUALITY GUIDELINES FOR FOODS 特殊...
Dosage form: A pharmaceutical product type (e.g., tablet, capsule, solution, cream) thatcontains a drug substance generally, but not necessarily, in association with excipients.Drug product: The dosage form in the final immediate packaging intended for marketing.Drug substance: The unformulated ...
美国FDA《联邦规章典集》(CFR)第21篇目录中文版-推荐下载
第B分章―用于人类消费的食品(SUBCHAPTER B―FOOD FOR HUMAN CONSUMPTION) 100 总则 GENERAL 101 食品标识 FOOD LABELING 102 非标准化食品的普通的或者通常的名称 COMMON OR USUAL NAME FOR NONSTANDARDIZED FOODS 104 食品的营养质量指南 NUTRITIONAL QUALITY GUIDELINES FOR FOODS ...
Unless otherwise justified, process water should, at a minimum, meet World Health 除非有其它理由,工艺用水最低限度应当符合世界卫生组织(WHO)的饮用水质量 Organization (WHO) guidelines for drinking (portable) water quality. 指南。 If drinking (portable) water is insufficient to ensure API quality and...
for aNDA •Key considerations of aNDAstability •Impact to the Generic Industry 2.pharmalytik(all rights reserved) 12/1/2014 2 •ACTIVEPHARMACEUTICAL INGREDIENT(API) –ToestablisharetestdateforAPI –Datatosupportsubmissionofdrugproduct •DRUGPRODUCT –Toestablishashelflifeforthecommercial product ...
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