Quality Assurance

Quality assurance in GCLP

As an independent team dedicated to GCLP compliance, we review the planning, execution, and results of sample analysis in clinical trials to ensure reliability. Our commitment to continuous quality improvement and strict regulatory adherence guarantees trustworthy analyses.

신뢰성보증

Procedure for sample analytical audit

  • • Analytical Procedure
  • • Validation Procedure
Analysis preparation
  • Designation of analytical personnel
  • Receipt of standard materials and reagents
Review of analytical methods
  • Technology transfer or development of analytical methods
Validation of analytical methods
  • Review of analytical plan
  • Audit of analytical process
  • Audit report
Sample analysis
  • Review of analytical plan
  • Audit of sample receipt
  • Audit of analytical process
  • Audit report
Data processing
  • Statistical analysis, Review of analytical results
  • Review of analytical report
  • Audit report
  • Issuance of Qaulity Assurance statement
Reporting results
  • Analytical report sent to sponsor
Analytical completion
  • Reference standards, reagents and samples transferred to sponsor
  • Audit of archive material
    Audit of sample return and disposal
  • Audit report