Procedures
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.