FDA-无菌药品生产指南(中英文版)介绍
Smoking, eating, drinking, chewing and the storage of food should be restricted to certain designated areas separate from the manufacturing areas. 吸烟、吃、喝、咀嚼及存放食品仅限于与生产区隔开的指定区域。 Personnel suffering from an infectious disease or having open lesions on the exposed surface ...
3.23Smoking,eating,drinking,chewingandthestorageoffoodshouldberestrictedtocertaindesignatedareasseparatefromthemanufacturingareas. 3.23吸烟、吃、喝、咀嚼及存放食品仅限于与生产区隔开的指定区域。3.24Personnelsufferingfromaninfectiousdiseaseorhavingopenlesionsontheexposedsurfaceofthebodyshouldnotengageinactivitiesthatcould...
1、copyright sci version 1 translated from / 译自: guidance for industry sterile drug products produced by aseptic processing current good manufacturing practice 行业指南 无菌加工生产的无菌药品 现行的生产质量管理规范(cgmp) u.s. department of health and human services food and drug administration ...
FDA无菌加工生产的无菌药品指南中英文对照版
contexts as live microorganisms which, when consumed in adequate amounts of food, confer a health benefit on the host (see Joint Food and Agriculture Organization and World Health Organization Working Group Report, “Guidelines for the Evaluation of Probiotics in Food” (April 30 and May 1, ...
110 在制造、包装或者保存人类食品中的现行良好制造规范 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD 113 装在密封容器中的热加工低酸食品 THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS 114 酸化食品 ACIDIFIED FOODS 115 带壳蛋 SHELL EGGS...
A manufacturer who intends to market a device of this generic type should (1) conform to the general controls of the Federal Food, Drug, and Cosmetic Act (the Act), including the premarket notification requirements described in? 21 CFR 807?Subpart E, (2) address the specific risks to ...
Food and Drug Administration Center for Drug Evaluation and Research (CDER) February 2019 Pharmaceutical Quality/CMC Pharmaceutical Quality/Manufacturing Standards (CGMP) 说明:本指导文件仅供建议说明之用。 本指导文件草案定稿后,将代表食品药品监督管理局(FDA或机构)对这一主题的当前想法。它不为任何人确立任何...
This article focuses on laws contained in Title 21 of the CFR, and the related FDA guidelines for GMP.Keywords:drug-related laws;Food and Drug Administration (FDA);Title 21;Code for Federal Regulations (CFR);goods manufacturing practices (GMP)...