This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern c

This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern c

Recent changes in the interpretation and enforcement of 21 CFR Part 11 have shifted the focus of Good Laboratory Practice (GLP) regulations to concentrate on th

This guidance book is meant as a resource to manufacturers of pharmaceuticals, providing up-to-date information concerning required and recommended quality syst