Standardization

Serum Origin Definitions

The ISIA has developed definitions of origin based on international guidelines set by the WTO, OIE, USDA, and the EU — providing precise wording to avoid confusion across the global serum supply chain.

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Serum origin definitions

The ISIA has developed definitions of origin based on international guidelines set by the WTO, OIE, USDA, and the EU. Since the word "origin" has several meanings and can cause confusion and controversy, ISIA suggests the use of very precise wording whenever possible.

The three key terms — Country of Collection, Country of Manufacturing, and Country of Further Treatment — each carry a distinct meaning that must be accurately documented on the Certificate of Analysis.

📄 Official ISIA Origin Definitions document
WTO OIE USDA EU ISIA Origin Standards ISIA suggests the use of very precise wording whenever possible
Three key origin terms
Term 1
Country of Collection
The country where the animal was slaughtered and the blood was collected — or in the case of donor animals, where the blood was collected. This is the country shown on the label as "origin" and is required on the Certificate of Analysis (CoA) and Certificate of Origin (CoO). Collecting blood and separating serum is considered substantial transformation.
Term 2
Country of Manufacturing
The country where filtration, bottling, and labeling occur, including any other processes performed prior to filtration and bottling. Other acceptable terms include "Manufacturing Address" or "Site of Manufacture". This should be listed on the CoA. Not considered substantial transformation.
Term 3
Country of Further Treatment
The country in which the product is treated after sterile filtration. Examples of further treatment include gamma irradiation or heat inactivation. These processes should be listed individually on the CoA and are not considered substantial transformation.
⚠️ The Country of Collection ("origin" on the label) does NOT change for import/export purposes. The Country of Collection can never change.
Countries of origin for bovine sera

Countries of origin

The knowledge of what a material is and where it was sourced is the core of the ISIA Traceability Program, and is critical to the credibility of the industry with customers and regulators. Almost the first action of the Association after it was formed was to agree on the definition of "origin" — currently defined as the location where the animal was killed or, in the case of donor animals, where the blood was collected.

According to the ISIA Traceability Program, Certificates of Origin or Analysis must reflect all origins present, in descending order of prevalence. ISIA strongly discourages the use of mixtures of sources except in specific instances such as Central American serum.

ISIA actively discourages the use of misnomers such as "USDA Approved", "USDA Grade", "EU Approved", or "EU Grade".

📄 Countries of Origin Information 📄 Verbiage to Replace USDA Approved Wording
Countries of Origin for Bovine Sera
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