Are the method used for determining the concentration validated?

The method we use for determining the concentration is not validated but it is verified in many ways, see below:

  • The spectrophotometers and pipettes used are calibrated (by a certified body).
  • The operators are tested on a yearly basis. The test shows accuracy, precision and variation between different operators. This test is documented and filed.
  • The measurement is performed in triplicate and these must not deviate from each other more than 3%. All steps are controlled by Standard Operating Procedures and are documented.