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or contact surfaces
and contamination
must be verified for each sample matrix by qualified personnel
For wholesale distribution of drug products in Europe
8.7 - Laboratory Controls - Stability Testing qc or contact surfacesDevelopmental 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
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