Technical Guidelines on Microbial Limit Researches for Non-sterile Chemical Drugs, Active Pharmaceutical Ingredients, and Excipients (Trial)
Request Technical Guidelines on Microbial Limit Researches for Non-sterile Chemical Drugs, Active Pharmaceutical Ingredients, and Excipients (Trial)
  • Local Title:非无菌化学药品及原辅料微生物限度研究技术指导原则(试行)
  • Country/Region:Chinese Mainland
  • Competent Authority: Center for Drug Evaluation (CDE)
  • Type:Guideline
  • Status:In force
  • Release Date:2023-02-21
  • Implementation Date:2023-02-21
Document
Language Source Title Access
ZH Official 非无菌化学药品及原辅料微生物限度研究技术指导原则(试行) Download
Summary

The guidelines systemically expound on the following aspects in microbial limit researches for the non-sterile chemical drugs, active pharmaceutical ingredients, and excipients:

1) control strategy;

2) testing method and the formulation of limits;

3) manufacturing process control;

4) points for attention in the researches.

The guidelines also specify the dossier requirements for microbial limit applications.