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An out of specification investigation must be completed each time a laboratory test
performed during the development of a new drug product
For wholesale distribution of drug products in Europe
must be used to determine appropriate storage conditions
at a minimum
4.0 - Equipment Overview testing An out of specification investigationEquipment used in the production or holding of a drug product shall be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use, cleaning and maintenance. Any surfaces that contact components, in process materials, or drug products shall not be reactive, additive, or absorptive
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