Good Manufacturing Practices Guide

The fifth edition of this Guide analyzes the contents of the current versions of the Good Manufacturing Practice (CGMP) rules and guidances laid down by the US, the European Union (EU), Canada, and Japan, the guidelines published by the World Health Organization (WHO), and the International Conference on Harmonization (ICH). The chapters of this Guide dealing with compliance take their order of contents from the content pages of the US Code of Federal Regulations #21CFR210-211—the principal GMP rules, and 21CFR600, the general regulations for the production of biologicals. Each topic is covered in turn, with emphasis being placed on the most critical requirements. A set of forms suitable for self-inspections, using as a format the FDA’s "Six Systems" approach, are provided as an appendix. There are also recommendations for dealing with external inspections, at the planning, implementation and follow-up stages. There are sections dealing with the key factors of the inspection of all types of manufacturing facilities, including instructions for staff behavior and the handling of official citations and warning letters. In order to ensure the maximum utility of this Guide, numerous references to Web sites, publications and conferences specializing in GMP compliance and training are provided at the end.

Includes shipping (via UPS Ground to the US including Puerto Rico, UPS Worldwide Expedited to other destinations) and handling and any applicable taxes.