FDA CVM GFI #169 Drug Substance Chemistry, Manufacturing, and Controls Information
标准简介
CVM GFI #169 Drug Substance Chemistry, Manufacturing, and Controls Information[附网盘链接]由FDA于过去发布，适用于美国。标准截图
![CVM GFI #169 Drug Substance Chemistry, Manufacturing, and Controls Information[附网盘链接]](/img/20210914103659roniu.jpg)
标准文档说明
标准文档类型为CVM GFI #169 Drug Substance Chemistry, Manufacturing, and Controls Information[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
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Guidance for Industry Drug Substance Chemistry, Manufacturing, and Controls Information This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. I. INTRODUCTION Information on the chemistry, manufacturing, and controls (CMC) for the drug substance must be submitted to support the approval of original new animal drug applications (NADAs) and 3
abbreviated new animal drug applications (ANADAs). This guidance provides recommendations on the CMC information for drug substances that should be submitted to support these applications. The guidance is structured to facilitate the preparation of applications submitted in Common Technical Document (CTD) format. This guidance addresses the information to be submitted for drug substances to ensure continued drug substance and drug product quality (i.e., the identity, strength, quality, purity, and potency). This guidance provides recommendations on the information that should be included for the following topics: • Nomenclature, structure, and general drug substance properties • Manufacture • Characterization • Control of drug substance • Reference standards or materials • Container closure system • Stability The recommendations provided in this guidance apply to the following types of drug substances: 2
This guidance has been prepared by the Office of New Animal Drug Evaluation in the Center for Veterinary Medicine at the Food and Drug Administration. 3
See 21 CFR 514.1(b). 1
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