Leonard Steinborn 
GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 2 – Regulations, Standards, and Guidelines) [PDF ebook] 
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 fa