Volume 2 • Sixth Edition
by Leonard Steinborn

Features:

• Offers changes in the global compliance requirements for the drug and medical industries and well as bulk chemical suppliers

• Includes changes for electronic records and signatures, FDA inspections, Norme European (EN) and many ISO changes

• Provides information on product liability and regulatory situations specific to these industries

The world's most widely recognized QA manual has been updated to provide the audit system you need to assess compliance with these new standards/regulations and those that continue in effect.

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 1. The book is organized to provide fast access to the guidelines and regulations of interest.

Contents

Volume 2 contains full texts of the regulations, standards, and guidelines referenced in Volume 1.

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