10.0 - Returned and Salvaged Drug Products bile tolerant

10.0 - Returned and Salvaged Drug Products bile tolerantReturned or reprocessed drug product shall be destroyed unless examination, testing, or other investigations prove the drug product meets appropriate standards of safety, identity, strength, quality, or purity. Drug products that have been subjected to improper storage conditions shall not be salvaged

shall be prepared

Any physical plant you use in the manufacture

These must be followed and documented at the time of performance

You must conduct all manufacturing operations in accordance with adequate sanitation principles

and is capable of operating satisfactorily within the operating limits required by the process

or absorptive

to enable that person to perform the assigned functions

Thereafter they must be stored under quarantine until they have been tested or examined

EP or other recognised test methods

pending the appropriate sampling

Any building used in the manufacture

shall be worn as necessary to protect drug products from contamination