Traceability

Overview of Traceability in Serum

Traceability ensures the origin, production, and handling of sera and animal-derived products can be followed and verified at every step — from blood collection to end use.

Traceability section
📖 Overview of Traceability
❓ Why Does Traceability Matter? → 🏅 ISIA Certification Process →

What is traceability?

Traceability refers to the process of ensuring the origin, production, and handling of sera and other animal derived products. It is critical for maintaining product quality, safety, and regulatory compliance in research, pharmaceutical, and biotechnological applications.

In every use of traceability, the beginning origin must be known. With serum, traceability encompasses the ability to follow unbroken documentation through every step in the process starting with where the blood was collected.

Though important for all animal-derived products, traceability is especially critical for fetal bovine serum (FBS), as the large global market and high pricing make it a potential target for adulteration to increase profits.

Collection Raw serum Processing & testing Final product

Why is traceability important?

Serum traceability matters because it ensures the quality, safety, ethical sourcing, and compliance of this critical biological material used in scientific research, biopharmaceutical production, and cell culture applications.

  • Reduced recall risk — Quickly identify the source of a problem and minimize impact on brand and customers.
  • Customer confidence — Transparency regarding product origins enhances trust and loyalty.
  • Cost savings — Early detection of issues prevents larger problems and saves money on recalls.
  • Brand reputation — Demonstrating commitment to quality and safety improves company image.
Reduced recall risk Customer confidence Cost savings Brand reputation

What is traceability certification?

The ISIA Traceability Certification is a standard designed to ensure transparency, accountability, and traceability within the global serum industry. It focuses on verifying and monitoring the entire supply chain of animal-derived sera used in vaccines, diagnostic tests, and biopharmaceutical products.

Increased confidence
Builds trust among customers, stakeholders, and regulatory authorities.
Regulatory compliance
Supports compliance with international regulations for biological materials.
Market advantage
Companies with ISIA certification gain a competitive edge, proving adherence to internationally recognized standards and attracting more clients and partners.
Traceability certification
How does origin relate to traceability?

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

📍
Country of Collection
The country where the animal was slaughtered and the blood was collected. This is the country shown on the label as "origin" and can never change for import/export purposes. Provided on the Certificate of Analysis (CoA) and Certificate of Origin (CoO).
🏭
Country of Manufacturing
The country where filtration, bottling, and labeling occur, including any processes performed prior. Listed on the Certificate of Analysis as "Manufacturing Address" or "Site of Manufacture". Not considered substantial transformation.
🔬
Country of Further Treatment
The country where the product is treated after sterile filtration, such as gamma irradiation or heat inactivation. These processes are listed individually on the CoA and are not considered substantial transformation.
Ready to get traceability certified?
Learn about the ISIA Traceability Certification process and how to apply.
Learn about certification →