4.0 - Equipment Overview testing Any deviation from the written

Any deviation from the written procedures shall be recorded and justified

There must be appropriately authorised and dated specifications for all components

before releasing for distribution

and the authority to review production records to assure that no errors have occurred or

performed during the development of a new drug product

4.0 - Equipment Overview testing Any deviation from the writtenEquipment 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