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Traceability

Traceability Certified Companies

Animal Technologies Inc.

Axenia Biologix

BioArra

Boval BioSolutions

Central Biomedia Inc

Life Technologies

Moregate Biotech

Proliant Health & Biologicals

River City Biologicals

Seradigm

Sera Labs Ltd.

Serum Technologies

Vacca Biologics LLC

For an overview of the ISIA traceability certification program click here

Traceability of Serum

Traceability of serum origin throughout the supply chain has become essential for all global GMP applications. We have identified the minimum standard documentation that is required for this purpose, and this is outlined in the document linked above. In future, you should be able to request the following documents from your 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 numbers for Donor Products), and documentation supporting all stages of processing and transportation or commercial transactions.

Non-transferability of Certification

  • Traceability certification, the right to use the ISIA Quality 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.