8.7 - Laboratory Controls - Stability Testing qc There shall be a quality

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

or contact surfaces

must be used to determine appropriate storage conditions

SOP and report form for tablet or capsule dissolution testing of by Quality Control according to USP <711> and EP 2

For wholesale distribution of drug products in Europe

8.7 - Laboratory Controls - Stability Testing qc There shall be a qualityDevelopmental 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