(a) There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no...
1302 对管制物质的标识与包装要求 LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES 1303 定额QUOTAS 1304 登记者的记录与报告 RECORDS AND REPORTS OF REGISTRANTS 1305 令的格式 ORDER FORMS 1306 处方PRESCRIPTIONS 1307 杂项MISCELLANEOUS 1308 管制物质的表 SCHEDULES OF CONTROLLED SUBSTANCES 1309 表I...
(a) There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no...
In your response to this letter, provide your SOP for line clearance and a comprehensive written evaluation of packaging and labeling operation, with emphasis on failure modes, capability, and design sufficiency. Provide an analysis including but not limited to, ...
• A comprehensive, independent written evaluation of packaging and labeling operations, with emphasis on failure modes, capability, and design sufficiency. Provide an analysis including but not limited to the following factors: •对包装和贴标操作进行全面、独立的书面评估,重点是失效模式、功能和设计充...
(a) There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no...
9Intrinsic means the microbial or fungalcontamination origina ted with the manufacture, packaging, shipping, or storage of thedrug, not from extrinsic sources, (e.g., consumer or health care provider useerrors). “内在”是指微生物或真菌污染源于药物的生产、包装、运输或储存,而不是来自外在来源(...
9. PACKAGING AND IDENTIFICATION LABELING OF APIs AND INTERMEDIATES 原料药和中间体的包装和贴签 9.1 General 总则 9.2 Packaging Materials 包装材料 9.3 Label Issuance and Control 标签发放与控制 9.4 Packaging and Labeling Operations 包装和贴签操作 10. STORAGE AND DISTRIBUTION.储存和分发 10.1 Warehousing Pr...
1302 对管制物质的标识与包装要求LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES 1303 定额QUOTAS 1304 登记者的记录与报告RECORDS AND REPORTS OF REGISTRANTS 1305 令的格式ORDER FORMS 1306 处方PRESCRIPTIONS 1307 杂项MISCELLANEOUS 1308 管制物质的表SCHEDULES OF CONTROLLED SUBSTANCES 1309 表I化学品的...
FoodandDrugAdministration 5100PaintBranchParkway CollegePark,MD20740 (Tel)240-402-2373 .fda.gov/FoodLabelingGuide TABLEOFCONTENTS 1.INTRODUCTION4 2.BACKGROUND4 3.GENERALFOODLABELINGREQUIREMENTS5 4.NAMEOFFOOD7 Juices 5.NETQUANTITYOFCONTENTSSTATEMENTS14 ...