Validation Center™

In September, 2009, PIC/S published a new version of their guide for GMP-inspectors to use during inspections of pharmaceutical manufacturing facilities.  Part II explains the principles and expectations for the manufacture of active substances used as starting materials in human and veterinary medicinal products. 

See section 5.4 for recommendations regarding computerized systems.  Refer to section 6.1 for references to electronic documents.  Read section 12 for validation expectations and section 13 for change control.