USP 62 Absence of Pseudomonas aer smoking and fungi that will grow

and fungi that will grow on Sabouraud Dextrose Agar SDA plates according to USP <61> and EP 2

when such water contacts components

there must be a comprehensively designed and correctly implemented Pharmaceutical Quality System incorporating Good Manufacturing Practice and Quality Risk Management

and under pressure as needed

the appropriateness of current specifications for both starting materials and finished product

USP 62 Absence of Pseudomonas aer smoking and fungi that will growSOP and report form for testing the absence of pathogenic Pseudomonas aeruginosa in products according to harmonized methods USP <62> and EP 2. 6. 13