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9.3 - Records and Reports - Holding and Distribution Records lab procedures You must establish appropriate specifications

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Description

You must establish appropriate specifications of identity

or any combination thereof

and validation

packaging material

Sufficient space should be given to avoid mix-ups and cross-contamination

9.3 - Records and Reports - Holding and Distribution Records lab procedures You must establish appropriate specificationsDistribution records shall contain the name and strength of the product and description of the dosage form, name and address of the consignee, date and quantity shipped, and lot or control number of the drug product, and must provide full and immediate traceability in the event of need to recall batches

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