8.7 - Laboratory Controls - Stability Testing qc SOP and report form for

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

must be verified for each sample matrix by qualified personnel

or contact surfaces

and contamination

independent from Production to permit the satisfactory operation of Quality Control

8.7 - Laboratory Controls - Stability Testing qc SOP and report form forDevelopmental 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