Bioanalytical Division


GLP SAMPLE ANALYSIS PROCEDURES

Below is a brief summary of Enthalpy's sample analysis procedures:

• Sample analysis activities are performed under FDA GLP regulations.

• A method details document (MDD) is written from the VOP and authorized prior to sample analysis.

• Each sample analysis set will contain at a minimum the following:

  • - One matrix blank
  • - One matrix control
  • - Single calibration standards spanning the quantitation range (concentrations defined during method validation activities)
  • - Triplicate quality control samples at three concentrations (defined during method validation activities)

• Acceptance criteria for each run are predefined by Enthalpy standard operating procedures.

• For each study, a draft study report is issued within 30 days of completion of sample analysis activities.

• Draft study report is finalized after Enthalpy receives Sponsor comments or 30 days later, whichever is sooner.

• When requested, Enthalpy will provide preliminary, non-QA reviewed data as studies proceed for monitoring purposes.