5.2 - Materials - Receipt and Storage lab specifications You must identify and use

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

Laboratory operations must be under the authority of a person with appropriate qualifications and experience

You must use adequate laboratory facilities to perform whatever testing and examinations are necessary to determine that specifications are met

The level of supervision must be proportional to the risk posed by the individual materials

covered by a marketing authorisation

5.2 - Materials - Receipt and Storage lab specifications You must identify and useUpon 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