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CFR 21 Part 211.170 – Production Retains Storage and Complaint Handling. An appropriately identified reserve sample that is representative of each lot in each shipment of each active ingredient shall be retained. 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.

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UNITED STATES

AMRI

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Retains & Complaint Resolution

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In accordance with CFR 21 Part 211.170 – Production Retains Storage and Complaint Handling, AMRI provides storage of reserve samples.

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Pharma Service: Analytical

Category: Packaging and Distribution Testing

Sub Category: Retains and Complaint Resolution

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