Overview of Standardization in Serum
Standardization ensures consistency, compatibility, and quality across serum products — from definitions and documentation to manufacturing procedures and regulatory compliance.
What is standardization?
Standardization is the process of developing, implementing, and maintaining technical standards to ensure consistency, compatibility, and quality across products, services, or processes.
Standardization of terminology, documentation, and manufacturing procedures has been a primary focus of ISIA since its inception. We work with government agencies to promote standardization of animal by-products regulations, the interpretation of those regulations, and enforcement.
An example of this collaboration has been the work ISIA has done with USP, working extensively in the production of a Fetal Bovine Serum standard for use in determining proficiency in the performance of growth promotion assays.
We have achieved considerable success with both standardization and harmonization, but governments of all nations continually legislate, regulate, and derogate — change is constant!