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independent from Production to permit the satisfactory operation of Quality Control
You must control the issuance and use of packaging and labels and reconciliation of any issuance and use discrepancies
or contact surfaces
each container
8.7 - Laboratory Controls - Stability Testing qc independent from Production to permitDevelopmental stability, performed during the development of a new drug product, must be used to determine appropriate storage conditions, specification acceptance criteria, and expiration dates. Routine stability, performed maximum annually once the drug is marketed, must be used to confirm these parameters on a periodic basis
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