清洗验证--葛兰素史克.pptVIP

Further advice on developing cleaning procedures can be found in GQP GQP 4302 Cleaning and Contamination Control. There is some debate over the acceptance criteria to be used to show the acceptable removal of cleaning agents if they must be used. US FDA have that cleaning agents are not part of the registered formulation and they expect that their absence is demonstrated by using “ultrasensitive” analytical techniques. EC have stated that”the efficiency of cleaning procedures for the removal of detergent residues should be evaluated. Acceptable limits should be defined for levels of dete