8.7 - Laboratory Controls - Stability Testing qc

8.7 - Laboratory Controls - Stability Testing qcDevelopmental 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

independent from Production to permit the satisfactory operation of Quality Control

For wholesale distribution of drug products in Europe

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

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

and contamination

must be used to determine appropriate storage conditions

each container

or break under compression during storage or transport

must be verified for each sample matrix by qualified personnel

or contact surfaces