Technical Guidelines for the Validation of Analytical Methods for Quality Control of Chemical Pharmaceuticals
Request Technical Guidelines for the Validation of Analytical Methods for Quality Control of Chemical Pharmaceuticals
  • Local Title:化学药物质量控制分析方法验证技术指导原则
  • 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 化学药物质量控制分析方法验证技术指导原则 Download
Summary

The Technical Guidelines for the Validation of Analytical Methods for Quality Control of Chemical Pharmaceuticals was issued on Mar. 18, 2005. It gives technical guidelines for the validation of analytical methods for quality control of chemical pharmaceuticals in China, which includes:

1. Overview

2. General Principles for Method Validation

3. Three Main Aspects Involved in Method Validation

4. Specific Content of Method Verification

5. Method Revalidation

6. Evaluation of Method Validation

7. References