This well-known QA manual has been updated to provide the guidance readers need to assess their compliance with standard regulations. This Volume 2 of a three-part package contains the full text on:

* FDA regulations

* EC and IPEC guidelines

* ISO/BSI standards referenced in the checklists furnished in volume 1

Easy-to-read and organized to provide fast access to guidelines and regulations, this is an essential reference for those working in the field.