Sub-Part I - Laboratory Controls

8.2 - Laboratory Controls - Representative Samples

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A sufficient representative sample must be collected from every lot received in every unique shipment, or every manufactured batch, of component, packaging, or drug, and must be tested or examined to determine whether the batch meets its established specifications of identity, strength, quality, and purity prior to release for production or distribution.

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Wine expert examining by swirling a representative sample glass of red wine as part of quality control