Overview of Standardization in Serum
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. ISIA has worked extensively with USP 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, thus complicating our task. Change is constant!
Areas of focus for Standardization
Definitions of Bovine Serum Types
In order to standardize serum definitions on a global basis in line with industry practice and regulatory trends, ISIA has developed very specific and detailed definitions for the entire range of possible bovine blood derived plasma and serum types.
Serum Origin Definitions
The ISIA has developed definitions of origin, based on international guidelines set by the WTO, OIE, as well as the USDA and the EU. Since the word “origin” has several meanings and can cause confusion and controversy, the ISIA suggests the use of very precise wording whenever possible.
ISIA Certificate of Analysis (CoA)
The much-anticipated ISIA Certificate of Analysis (CoA) guidance document is here. After many years of work and deliberation by our members, we are happy to share our official guidance on the Certificate of Analysis (CoA).
Scientific Names for Certain Animal Species
As we continue to educate our members and others in the serum industry a reference document has been created including Scientific Names for Certain Animal Species.
