8.7 - Laboratory Controls - Stability Testing qc Components and drug product containers

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

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

each container

or break under compression during storage or transport

8.7 - Laboratory Controls - Stability Testing qc Components and drug product containersDevelopmental 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