What is Traceability?

Farm-to-table (or farm-to-fork) refers to the stages of the production of food: harvesting, storage, processing, packaging, sales and consumption. (Wikipedia) This simple definition is the core of Traceability: to be able to follow an unbroken paper-chain through every stage of production of a product from its origin to the end user. This process is enshrined in law and GMP SOPs and is a core component of the ISIA ethos. In other words, what you see on the label is a true and accurate description and its entire manufacturing history is open to audit by both government agencies and customers.

Traceability of Serum

Traceability of serum origin throughout the supply chain has become essential for all global GMP applications. In line with our policy on standardization, we have identified the minimum standard documentation that is required for this purpose, and this is outlined in the ISIA Traceability Certification overview linked below. Your ISIA member supplier must be able to provide a Certificate of Origin, certifying the origin of the original blood.

Certificate of Origin

This certificate describes 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, a Certificate of Origin, or a Certificate of Analysis where that is provided, must reflect all origins present, if in fact a mixture of sources exists. This should state the origins present in descending order of the amount of each present. ISIA strongly discourages the use of mixtures of sources except in specific instances such as Central American Serum.

ISIA also discourages the use of misnomers in sourcing nomenclature. We recognize that there is no such thing as "USDA Grade", "EU Approved" or "EU Grade", but understand that the customer is used to this terminology and that it will take intensive effort to eliminate these descriptions.

Non-transferability of Traceability Certification

Traceability certification, the right to use the ISIA Seal and the ability to claim certification is granted solely to those companies that have fulfilled the criteria for certification and cannot be transferred under any circumstances. Purchase of material from a certified company, or processing of material by a certified company, confers no right to claim or imply Traceability Certification.

Traceability Certified Companies

Click here to view a list of the current ISIA Member companies.


Dr. Versteegen, ISIA's CEO, discusses the benefits of being ISIA Traceability Certified.

For an overview of the ISIA Traceability Certification program click here.


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