FDA Annex 13 Bulk Density and Tapped Density of Powders General Chapter

标准简介

标准截图

标准文档说明

标准部分原文

1

Guidance for Industry Q4B Evaluation and Recommendation of Pharmacopoeial Texts

for Use in the ICH Regions

Annex 13

Bulk Density and Tapped Density of Powders General Chapter

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. 2 1. INTRODUCTION (1) This annex is one in a series of guidance documents that describe the evaluations and recommendations by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions. Implementation of the Q4B annexes is intended to avoid redundant testing by industry. For general information on the Q4B process, the reader is referred to the core guidance Q4B 3 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions. This annex is the result of the Q4B process for the Bulk Density and Tapped Density of Powders Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG). FDA's guidance documents, including this guidance, 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 1 This guidance was developed within the Expert Working Group (Quality) of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and has been subject to consultation by the regulatory parties, in accordance with the ICH process. This document has been endorsed by the ICH Steering Committee at Step 4 of the ICH process, June 2012. At Step 4 of the process, the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan, and the United States. 2

Arabic numbers reflect the organizational breakdown of the document endorsed by the ICH Steering Committee at Step 4 of the ICH process, Ju ne 2012. 3

We update guidance documents periodically. To make sure you have the most recent version of a guidance, check the FDA Drugs guidance page at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/default.htm or the FDA Biologics guidance page at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. 1

网盘链接

百度网盘：https://pan.baidu.com/s/1CWQsAZ3ltyGoOIJgG5GXyw
提取码：b4jp