Chinese Pharmacopoeia 9100 Guidelines for Analytical Method Transfer
Request Chinese Pharmacopoeia 9100 Guidelines for Analytical Method Transfer
  • Local Title:9100 分析方法转移指导原则
  • Country/Region:Chinese Mainland
  • Competent Authority: Chinese Pharmacopoeia Commission
  • Type:Guideline
  • Status:In force
  • Release Date:2020-07-02
  • Implementation Date:2020-12-30
Summary

Analytical method transfer is a process of document recording and experimental confirmation. The purpose is to demonstrate that when one laboratory (method receiving laboratory) uses a non-statutory analytical method established and verified by another laboratory, the method receiving laboratory has the ability to successfully operate the method and achieve the test results that are consistent with the those of the method establishment laboratory. The transfer of analytical methods is an important link to ensure that consistent, reliable, and accurate test results are obtained between different laboratories; it is also an important assessment of the laboratory's test ability.

This Guidelines summarizes the possible analysis methods, types of transfer and contents of transfer schemes. The Guidelines does not provide information on statistical methods, nor does it include the transfer of microbiological and biological testing methods.