Why is traceability important?
Traceability is important because it provides a chain of identity of the product from the country and slaughterhouse of origin, to the processing, packaging and labeling facilities ready for sale and final distribution. As you can verify, traceability insure that the product you buy was made respecting regulations at each level. This unbroken chain of information means complete transparency and entire compliance.
How does Biowest guarantee traceability?
Biowest completely controls the supply chain from harvesting the raw material to filling sterile bottles.
Our traceability with SAP management software SAP SAHANA guarantees complete product traceability, from raw material until the end product. This software program plays a key role for achieving complete supply network traceability - enabling Biowest to determine batch lineage and global traceability.
How relevant is the country-of-origin?
High quality serum can originate from any country, as long as it is collected, imported, and processed following all the applicable regulatory and industry requirements. No one continent or country which produces FBS has an inherent advantage, in terms of quality, over other origins.
How is the origin of serum determined?
For raw serum, the country of origin is where the serum was collected. For finished serum, the country of origin is where the serum was last processed.
What about regulations and conformity?
Since the 1990s, from time to time, cases of illegal practices have been rumored. Only two cases are known to have been reported to authorities. In 2004, Biowest realized we had purchased and resold misrepresented origins; and in 2013, GE realized it had been selling misrepresented and adulterated FBS products, after acquiring the company PAA with activities in Austria, Canada and Australia. In both cases affected victims were informed, and product was recalled. Other cases are known to be under investigation. These cases illustrate the importance of having complete control of the supply chain.
What is adulteration?
"Adulteration" is the most damaging of the criminal activities that may affect serum users!
FBS can be adulterated by the addition of water, growth factors and/or serum of other species. Unscrupulous companies in order to enhance performance and/or lower the cost of the product can carry out one or more of these or similar activities. These practices are extremely serious as they affect critical results of life science research, and the purity of final products obtained in biopharmaceuticals, diagnostics, or vaccines. When such cases are detected, victims having used adulterated product must be informed to make it possible to evaluate the damage and take corrective actions.
What about misrepresentation and smuggling?
- "Misrepresentation" is when the product is mislabeled in terms of the declared origin, and can be total or partial: "Total" is when FBS from a less expensive origin is sold as if it were from a more expensive origin; "Partial" is when a less expensive origin and a more expensive origin are mixed e.g. in proportion 49-51, and only the more expensive 51%- origin is declared. This generates an illicit profit for seller, at the expense of the serum users; and may cause companies to unknowingly violate import regulations or product master files. The actual research results and end products are unlikely to be seriously affected, but falsified origins violate government, industry and consumer standards of honesty and traceability.
- "Smuggling" is a way of misrepresentation, and can be in the form of importing a product under a false description; directly to a final destination, or via third country.