GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 2 - Regulations, Standards, and Guidelines)

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 1Easy-to-read and organized to provide fast access to guidelines and regulations, this is an essential reference for those working in the field.