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Technical Guidelines for Quality Comparability Studies of Vaccine Production Site Changes
Request Technical Guidelines for Quality Comparability Studies of Vaccine Production Site Changes
  • Local Title:疫苗生产场地变更质量可比性研究技术指导原则
  • Country/Region:Chinese Mainland
  • Competent Authority: Former China Food and Drug Administration (CFDA)
  • Type:Guideline
  • Status:In force
  • Release Date:2014-01-08
  • Implementation Date:2014-01-08
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ZH Official 疫苗生产场地变更质量可比性研究技术指导原则 Download
Summary

The Technical Guidelines for Quality Comparability Studies of Vaccine Production Site Changes was issued on Jan.08, 2014. It aims to further strengthen the registration management of vaccine production site changes, which includes:

1. Basic Principles

2. Project Design

3. Production Process and Product Quality

4. Characteristic Analysis of Different Vaccines

5. Notes

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