Overview of Traceability in Serum
What is traceability?
Traceability refers to the process of ensuring that the origin, production, and handling of sera and other animal derived products. Traceability 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 for the product or system to be traceable. The same is true for the serum industry. 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.
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.
Traceability offers:
Reduced risk of product recalls: By identifying the source of a problem quickly, companies can minimize the impact of recalls on their brand and customers.
Improved customer confidence: Transparency regarding product origins and quality can enhance customer trust and loyalty.
Cost savings: Early detection of issues can prevent larger problems down the line, saving companies money on recalls and rework.
Enhanced brand reputation: Being able to demonstrate commitment to quality and safety through traceability can improve a company's image.
What is traceability certification?
The International Serum Industry Association (ISIA) Traceability Certification is a standard designed to ensure transparency, accountability, and traceability within the global serum industry. This certification primarily focuses on verifying and monitoring the entire supply chain process of animal-derived sera used in the production of vaccines, diagnostic tests, and other biopharmaceutical products.
Benefits:
Increased Confidence: Certification helps build trust among customers, stakeholders, and regulatory authorities by demonstrating a commitment to high-quality standards.
Regulatory Compliance: It supports compliance with international regulations related to the use of biological materials.
Market Advantage: Companies with ISIA traceability certification may gain a competitive edge by proving their adherence to internationally recognized standards, potentially attracting more clients and partners.
How does origin relate to traceability?
The ISIA has developed definitions of origin, based on international guidelines set by the WTO, WOAH, as well as the USDA and the EU. Since the word “origin” has several meanings and can cause confusion and controversy, the ISIA suggests the use of very precise wording whenever possible.
Country of Collection: This is 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 includes animals born and raised in the country of collection, as well as imported animals, and may include animals imported for immediate slaughter. This is the country shown on the label as “origin”. Industry best practice is that the Country of Collection is provided on the Certificate of Analysis (CoA) and Certificate of Origin (CoO). The process of collecting blood and separating serum is 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.
Country of Manufacturing: This is the country where filtration, bottling, and labeling occur and includes 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. This is not considered substantial transformation.
Country of Further Treatment: This is the country in which the product is treated after sterile filtration. Examples of further treatment are gamma irradiation or heat inactivation. These processes should be listed individually on the CoA and are not considered substantial transformation.
