Quality Control Standardization

An early ISIA objective has been to assist customers around the world in comparing quality and physiochemical analyses of different batches of serum, or different regulatory specifications.

As early as 2007, a questionnaire was distributed to all ISIA members to develop an industry wide view of quality control testing. Data was analyzed and a white paper developed to define those tests and documentation where standardization will allow the industry to serve the customer better and in a less confusing manner. A proposal for a standardized Certificate of Analysis was formulated.

In 2017, the questionnaire was revisited and the quality control matrix was updated.

  • Click here to review the current quality control matrix for test methods and specifications.
  • Click here to review why we perform these tests.
  • Click here - Cerificate of Analysis / ISIA's suggestions for the minimum requirements on a CofA

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