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ISIA Traceability Certification

Traceability Certified Companies

The following ISIA Member companies have been auditied by an independent auditor according to the ISIA Traceability Audit Checklist and found to comply in all respects with its requirements. They are entitled to use the ISIA Seal on their marketing material, during the period that their certification remains current.

Abattoir Basics Company
Animal Technologies Inc.
Atlas Biologicals, Inc.

Axenia Biologix
Biomin Biotechnologia LTDA
By Productos S.A de C.V.
Central Biomedia Inc.
GE Healthcare
Gibco by Thermo Fisher Scientific
Life Science Production
Moregate Biotech
Newman Biotech Australia
Proliant Biologicals
River City Biologicals
Rocky Mountain Biological
Serum Technologies
TCS Biosciences, Ltd
Vacca Biologics LLC


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 and 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 document linked below. In future, you should be able to request the following documents from your ISIA member supplier.

      • A Certificate of Traceability from the manufacturer of the goods certifying that they have on file full traceability of the origin and supply chain for the specified batch of serum.

      • A Certificate of Origin from the manufacturer of the goods certifying the origin of the original blood used for the production.

Certificate of Traceability

The manufacturer is required to maintain records of traceability of all stages in the supply chain for serum batches. This includes auditable history of quality and quantity of materials from the point of collection (including specific animal identification for Donor Products), and documentation supporting all stages of processing and transportation or commercial transactions.

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. This definition may be narrowed in the future. According to the ISIA Traceability Program, Certificates of Origin or Analysis must reflect all origins present (if in fact a mixture of sources exists) and also reflect the precentages of each. 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 fullfilled 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 infer Traceability Certification.

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

Did you know - that China now has a check box on their serum import form asking if the serum has been ISIA Traceability Certified ?