3.5 - Water Supply qms responsibilities There shall be written procedures

There shall be written procedures for production and process control designed to assure that the drug products have the correct identity

SOP and report form for testing the absence of pathogenic Pseudomonas aeruginosa in products according to harmonized methods USP <62> and EP 2

examination or the result of any monitoring fails to meet an established specification

Any building used in the manufacture

Procedure and report form for the absence of Enterobacteria coliforms in products according to the principles of harmonized method USP <62> and EP 2

3.5 - Water Supply qms responsibilities There shall be written proceduresYou must provide water that is safe and sanitary, at suitable temperatures, and under pressure as needed, for all uses where water does not become a component of the dietary supplement. Water that is used in a manner such that the water may become a component of the dietary supplement, e. g., when such water contacts components, dietary supplements, or any contact surface, must, at a minimum, comply with applicable Federal, State, and local