USP 62 Absence of Pseudomonas aer smoking by Quality Control according to

by Quality Control according to USP <1217> and EP 2

SOP and report form for the Quality Control testing to prove the absence or presence of E coli in products or materials according to USP and EP global harmonized methods

Microbiological pharmacopeia methods are considered to have been validated however the performance criteria and the suitability for each product type must be verified

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

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

USP 62 Absence of Pseudomonas aer smoking by Quality Control according toSOP and report form for testing the absence of pathogenic Pseudomonas aeruginosa in products according to harmonized methods USP <62> and EP 2. 6. 13