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Monitoring of the quality and safety of biological-biotechnological products

Once PAHO agrees to procure the biological-biotechnological products for the member countries to use in their health programs, there is a series of commitments that suppliers must meet so that the quality and safety of the product batches procured can be ascertained, particularly: the batch release certificates issued by the NRA of the country of origin (for blood products), the summary production and control protocol, and the certificate of analysis, among others.

However, it should be pointed out that the post-marketing sanitary surveillance systems set up by the country NRAs are essential for monitoring the quality, safety, and efficacy of the products used, facilitating the necessary feedback between manufacturers, PAHO, NRAs, and the users to whom the products are targeted.

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