Traceability

ISIA Traceability Certification Process

The ISIA Traceability Certification Program provides a rigorous, independently audited standard for verifying the origin and quality of animal sera throughout the entire supply chain.

Traceability certification overview

The ISIA traceability audit is tailored and customized to each individual company's processes, ensuring the certification is meaningful and relevant to your specific supply chain operations.

Did you know?
The audit includes:
Review of sourcing documentation
Assessing chain-of-custody records including mass balance verification
Reviewing compliance with industry standards and regulations
Random sampling of serum by the auditor for geographic testing
STEP 01 APPLICATION Companies voluntarily apply to ISIA for traceability certification. STEP 02 SCOPE Define what is included in the audit based upon the applicant's unique business. STEP 03 AUDIT ISIA approved auditor conducts a detailed audit of records and processes. STEP 04 APPROVAL If the audit is successful, ISIA issues a Traceability Certification. STEP 05 ONGOING MONITORING Companies are periodically reviewed to ensure continued compliance. Certification encompasses: Fetal bovine serum (FBS) and other animal sera Serum-derived products used in pharma, diagnostics, and research Manufacturers, processors and distributors

Geographic testing for FBS

Geographic testing for fetal bovine serum (FBS) is a chemical analysis method that uses trace elements to verify the geographic origin of a serum product. ISIA developed this method in partnership with Oritain Global Limited to support the traceability program.

While the country of origin can be a factor in regulatory requirements, the quality of FBS is not necessarily tied to its geographic origin — high-quality FBS can come from any country as long as it meets regulatory and industry standards.

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Animal health
Risk of infectious diseases and animal health status can impact FBS availability.
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Global events
Weather events can impact animal husbandry and affect FBS supply.
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Demand
Global demand for FBS, a finite resource, increases year after year.
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ISIA/Oritain Whitepaper
Testing for Geographic Origin of Fetal Bovine Serum →
ISIA/Oritain Whitepaper

Age testing for FBS

Age testing refers to the ability to differentiate between fetal bovine serum and newborn or calf serum. This is crucial because true FBS must be derived from bovine fetal blood.

This test was developed by ISIA and has been adopted by the industry, with results shown on Certificates of Analysis.

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ISIA Age Testing Whitepaper
Learn more about the age testing process →
FBS Fetal vs NCS Newborn ISIA Age Testing Differentiating FBS from newborn serum
Ready to become traceability certified?
Contact ISIA to begin the certification process for your organization.
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