8.7 - Laboratory Controls - Stability Testing qc each container

each container

or contact surfaces

There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components

Components and drug product containers and closures shall at all times be handled and stored in a manner to prevent contamination

You must control the issuance and use of packaging and labels and reconciliation of any issuance and use discrepancies

8.7 - Laboratory Controls - Stability Testing qc each containerDevelopmental 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