10.0 - Returned and Salvaged Drug Products bile tolerant EP or other recognised test

EP or other recognised test methods

shall be worn as necessary to protect drug products from contamination

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

10.0 - Returned and Salvaged Drug Products bile tolerant EP or other recognised testReturned 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