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

Volume 2 of this set contains the full text of the FDA regulations, EC and IPEC guidelines, and ISO/BSI standards referenced in the checklists furnished in Volume I

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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.