Chinese Pharmacopoeia 9099 Guidelines for Analytical Method Verification
Request Chinese Pharmacopoeia 9099 Guidelines for Analytical Method Verification
  • Local Title:9099 分析方法确认指导原则
  • 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 verification means that when the legal analysis method is used for the first time, the existing analysts or laboratories conduct selective investigation on the key verification indicators in the analysis method to prove the applicability of the method to the analyzed samples and prove that the analysts are capable of using the legal analysis method. Guideline 9101 "Guidelines for Validation of Analytical Methods" provides the indicators that need to be validated for the establishment of analytical methods. The validation of analytical methods is not a repeated validation process. This Guidelines does not involve the validation of microbiological analysis methods.