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Batch Release

In order to complete the process Farma-APS integrates a Qualified Person (Q.P), responsible to ensure that each batch of medicinal product has been manufactured and checked in accordance with the requirements of its marketing authorization and current EC Good Manufacturing Practice guidelines before it is released within the European Community (EC) or European Economic Area (EEA).

Batch Release

This service is particularly important for the cases where a batch has had different stages of production or testing conducted at different locations or by different manufacturers, and where an intermediate or bulk production batch is divided into more than one finished product batch. It also covers the release of batches which have been imported to the EC/EEA both when there is and is not a mutual recognition agreement between the Community and the third country.