Research And Markets - All Manufacturers Of Pharmaceutical Products, Biologics, Diagnostics And Devices Controlled By The FDA And Similar Overseas Authorities Are Subject To Facility Inspections, Both Before Approval Of A New Product And Routinely Thereafter

Research and Markets (researchandmarkets.com/reports/c10621) has announced the addition of A Guide to Good Manufacturing Practice, 2nd Edition to their offering.

(PRWEB) December 6, 2004 -- A Guide to Good Manufacturing Practices, 2nd Edition analyzes the contents of the latest versions of the GMP rules laid down by the USA, Canada and Japan, ICH, the EC and WHO. This Guide provides pharmaceutical and biological companies of all sizes with assistance in compliance with these rules. The Guide is addressed particularly to smaller sized companies, perhaps those with their first new drug, working on this extra challenge to their capabilities.

Research and Markets (http://www.researchandmarkets.com/reports/c10621) has announced the addition of A Guide to Good Manufacturing Practice, 2nd Edition to their offering.

The regulations and guidelines outlining GMP originated with the Food and Drug Administration (FDA) of the USA, and have been in operation in their current form since 1978. Other countries, including Canada, Japan, Australia, Switzerland and the members of the European Union, have published similar codes. The codes are empowered by national regulations.

Moves to harmonize these codes internationally have taken place, under ICH auspices. However, a recent review of the contents of the regulations from major players in the pharmaceutical industry concluded that there were far more similarities than differences in these rules. To this end, the ICH decided in the year 2000 that the only new GMP guidance that was needed was for the manufacturers of active pharmaceutical ingredients in bulk-the existing regulations for finished products were adequate.

The contents of this report are as follows:

Chapter 1: Executive Summary

Chapter 2: Introduction

Chapter 3: International Regulations Governing GMP

Chapter 4: Standard Operating Procedures

Chapter 5: Validation of Procedures, Processes, and Methods

Chapter 6: Critical Compliance Issues for Active Principal

Chapter 7: Critical Compliance Issues for Biologicals

Chapter 8: Preparation of ICH Manufacturing Documentation

Chapter 9: Internal and External Inspections

Chapter 10: Conclusions

Chapter 11: References and Further Reading

Chapter 12: Appendices

TABLE OF EXHIBITS

For more information visit http://www.researchandmarkets.com/reports/c10621

Laura Wood

Senior Manager

Research and Markets

press@researchandmarkets.com

Fax: +353 1 4100 980

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