10.0 - Returned and Salvaged Drug Products bile tolerant and is capable of operating

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

EP or other recognised test methods

shall be prepared

shall be worn as necessary to protect drug products from contamination

Any building used in the manufacture

10.0 - Returned and Salvaged Drug Products bile tolerant and is capable of operatingReturned 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