Date Published:
Tue, 09/01/2009In September, 2009, PIC/S published a new version of their guide for GMP-inspectors to use during inspections of pharmaceutical manufacturing facilities. Part 1 explains the principles and expectations for the manufacture of medicinal products. See section 4.9 for recommendations regarding electronic records. Refer to sections 4.26 and 5.21-5.24 for validation expectations.