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and the authority to review production records to assure that no errors have occurred or
Any deviation from the written procedures shall be recorded and justified
An out of specification investigation must be completed each time a laboratory test
contact surfaces
before releasing for distribution
4.0 - Equipment Overview testing and the authority to reviewEquipment 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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