FDA CVM GFI #255 Elemental Impurities in Animal Drug Products Questions and Answers
标准简介
CVM GFI #255 Elemental Impurities in Animal Drug Products Questions and Answers[附网盘链接]是Food&Drug Administration发布的FDA标准，适用于United States。标准截图
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标准文档说明
标准文档类型为CVM GFI #255 Elemental Impurities in Animal Drug Products Questions and Answers[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
Elemental Impurities in Animal Drug Products Questions and Answers Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page. I. INTRODUCTION This guidance is intended to assist sponsors of animal drug products in addressing changes in the 1
United States Pharmacopeia (USP) requirements for the control of elemental impurities in drug products marketed in the United States. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency’s guidances means that something is suggested or recommended, but not required. II. BACKGROUND AND SCOPE USP General Chapter <231>, Heavy Metals, was deleted with the implementation of General Chapters <232>, Elemental Impurities – Limits, and <233>, Elemental Impurities – Procedures. While USP <232> does not apply to animal drug products, the Center for Veterinary Medicine (CVM) expects sponsors of animal drug products to continue to apply a risk-based control strategy for elemental impurities and establish appropriate acceptance criteria and test methods for elemental impurities where necessary. Ensuring that elemental impurities in the final drug product are controlled within safe limits remains the responsibility of the sponsor of the animal drug product. This document provides recommendations to sponsors regarding the control of elemental impurities in animal drug products, including pending and approved applications for all dosage forms and routes of administration. The information to be maintained on-site and information to be submitted to CVM is also clarified. The submission of information regarding components and composition, as well as manufacturing methods, facilities, and controls is required under 21 CFR 514.1(b)(4) and (5) for new animal drug applications and under section 512(n)(1)(G) of the Federal Food, Drug, and Cosmetic Act for abbreviated new animal drug applications. The 1
http://www.usp.org/
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