Traceability compliance and whole-process risk control of fetal bovine serum in biomedical R&D scenarios

Regulatory positioning of fetal bovine serum as a raw material of animal origin

Fetal bovine serum is a typical animal-derived raw material in the biomedical field. It is widely used in many aspects such as antibody drug research and development, cell therapy product preparation, and in vitro diagnostic reagent production. Its quality compliance directly affects the declaration progress of R&D projects and the safety of final products.Due to the potential risk of animal-derived raw materials carrying exogenous pathogens, regulatory agencies in major markets around the world have put forward clear requirements for the source control and quality standards of such raw materials. China's biomedical related regulatory system is also continuing to improve. Relevant enterprises need to establish a management mechanism covering the whole life cycle of fetal bovine serum.

Core construction points of the fetal bovine serum traceability system

Full link traceability is the core of fetal bovine serum compliance management. When enterprises build traceability systems, they need to focus on the following links:

Blood collection information can be traced: Compliant fetal bovine serum must be traced back to the specific blood collection pasture, and can be linked to cattle breeding information if necessary. Documents such as quarantine certificates of origin, official statements of non-epidemic areas, and veterinary supervision records of the blood collection process are provided to ensure that the blood collection process meets the general norms of animal health and epidemic prevention. It is strictly forbidden to purchase or use fetal bovine serum from an epidemic area of unknown origin.

Production and processing: The whole process from raw material blood sampling, cold chain transportation, separation and purification, multi-level filtration and sterilization to finished product inspection, warehousing and warehousing needs to have a complete batch production record. The processing technology and quality control standards of different batches of products remain unified, and problems can be quickly located once quality problems occur.