Qutem lab

Method validation

QuTEM performs validation studies of analytical protocols to assure the quality and consistency of Transmission Electron Microscopy (TEM) testing for our clients and their products. 

Our method validation studies are designed and executed according to international guidelines (ICH Q2 R2) to demonstrate with documented evidence that our cryogenic TEM (cryoTEM) or negative stain TEM (nsTEM) methods are suitable for determining a specified quality attribute. 

QuTEM Lab loading station

GMP-certified 

Assure the quality and legitimacy of the analytical results

Validation tests

according to ICH Q2 (R2) guidelines.

Specificity

Repeatability

Intermediate precision

linearity

Linearity

accuracy

Dilutional accuracy

range

Range

Robustness

Validation process

The typical steps for a method validation study at QuTEM:

  • Establish a Method of Analysis (MoA, i.e., analytical protocol)
  • Perform pre-validation tests
  • Establish validation plan
  • Perform validation tests
  • Generate validation report
  • Validation study completed and MoA status updated to "validated"
GMP_LAB2023-SAMPLE-PREP_1
GMP stamp_1

Want to know more about method validation studies?

 

Contact us

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