In accordance with CFR 21 Part 211.170 – Production Retains Storage and Complaint Handling, we provide storage of reserve samples. We retain an identified reserve sample that is representative of each lot in each shipment of each active ingredient. The reserve sample consists of at least twice the quantity necessary for all tests required to determine whether the active ingredient meets its established specifications, except for sterility and pyrogen testing.

In addition, our experts assist in complaint handling of your product, providing appropriate testing, data and consultation in a solution customized for you.

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