The WFH is not a regulatory agency and cannot make recommendations relating to the safety of specific blood products. The regulatory authority in a particular country must make these judgments based on domestic legislation, national health policies, and clinical best practices.
A government or regulatory authority can ensure the safety of a blood product by determining the source of the plasma, the viral inactivation processes used in manufacturing, and the results of clinical trials related to the product in question.
To properly assess the safety of a factor concentrate, national regulatory agencies must have detailed, verifiable information on:
The quality of the plasma raw material including the regulatory status of the plasma supplier, donor epidemiology, donor exclusion criteria, screening tests done on the blood/plasma, quality assurance measures, details of the inventory hold system, the plasma pool size, and testing of the plasma pool.
The manufacturing process, including the manufacturing steps and related in-process controls, specific viral inactivation and removal steps, process consistency, and batch release specifications.
The final product, including the product’s history, and clinical studies demonstrating the product’s safety and efficacy.
The WFH would therefore suggest that concerns about the safety of products be expressed to the relevant authorities including asking them to share the information they have obtained from the manufacturer in answer to the key questions outlined above.
Approved: January 23, 2003
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