9.3 - Records and Reports - Holding and Distribution Records lab procedures Sufficient space should be given

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

Failure to meet any specification must be investigated by Quality Control

and validation

or label to make it suitable for use in the manufacture of a dietary supplement unless Quality control personnel conduct a material review and make a disposition decision to approve this

9.3 - Records and Reports - Holding and Distribution Records lab procedures Sufficient space should be givenDistribution 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