Appropriate data for one project may be excessive for another, or hardly enough. For these reasons, this presentation focused not on details, which by necessity will vary, but on global issues. When choosing the appropriate tests and the means for validating them, make sure that you are measuring the appropriate parameter and that the tests are performing as intended. These are the most critical issues. Choose the appropriate tests and standards.
Products exhibit a continuum of complexity.
Some products may have simple, chemically definable structures, and the appropriate testing methods for them may be well established and easy to conduct. Other products may be complex cellular materials, biological agents, or tissues. It depends on the nature of the product, the manufacturing process, the stage of development, and the state of the art in analytical technology. Once tests have been chosen, the next critical aspect is use of validated methods with appropriate standards. An excellent example of this is the peptide mapping of recombinant bovine somatotropin by John Dougherty et al.