5.2 - Materials - Receipt and Storage lab specifications covered by a marketing authorisation

covered by a marketing authorisation

quality or efficacy

You must identify and use an appropriate scientifically valid method for each established specification for which testing or examination is required to determine whether the specification is met

contamination

5.2 - Materials - Receipt and Storage lab specifications covered by a marketing authorisationUpon receipt, each container, or group of containers, of materials or drug product must be examined visually for appropriate labeling as to contents, container damage or broken seals, and contamination. Thereafter they must be stored under quarantine until they have been tested or examined, and released, then stored without mix up or contamination