Changecontrol课程.pptVIP

ICH Q7A GMP Guidance for APIs -Process Equipment, Cleaning Cleaning Validation October 22-24, 2001 FDA, PDA, PhRMA, and GPhA Joint Q7A Training, Chicago, Ill. ICH Q7A GMP Guidance for APIs 13 Change Control Raw materials Specifications Analytical methods Facilities Support systems Equipment Process steps Labelling and packaging materials Computer hard- software 13 Change Control Any proposals for GMP relevant changes should be Drafted, reviewed and approved by the appropriate organisational units Approved by the quality unit(s) 13 Change Control The potential for impact of the proposed cha