Technical Guidelines for the Standardization of the Process of Establishing Quality Standards for Chemical Pharmaceuticals
Request Technical Guidelines for the Standardization of the Process of Establishing Quality Standards for Chemical Pharmaceuticals
  • Local Title:化学药物质量标准建立的规范化过程技术指导原则
  • Country/Region:Chinese Mainland
  • Competent Authority: Former China Food and Drug Administration (CFDA)
  • Type:Guideline
  • Status:In force
  • Release Date:2005-03-18
  • Implementation Date:2005-03-18
Document
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ZH Official 化学药物质量标准建立的规范化过程技术指导原则 Download
Summary

The Technical Guidelines for the Standardization of the Process of Establishing Quality Standards for Chemical Pharmaceuticals was issued on Mar. 18, 2005. It gives technical guidelines for the standardization of the process of establishing quality standards for chemical pharmaceuticals in China, which includes:

1. Overview

2. Basic Process of Establishing Quality Standards

3. Pharmaceutical Quality Research

4. Establishment of Quality Standards

5. Revision of Quality Standards

6. References