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Guide to Good Laboratory Practice, 3rd Edition
Drug and Market Development Publishing, Aug 2007, Pages: 242
The Guide to Good Laboratory Practice, 3rd Edition examines the GLP regulations in the United States and other countries in detail, and gives firm guidelines for compliance, using as a basis the GLP requirements published in the U.S.A Code of Federal Regulations, Title 21, Part 58, 2006 Edition (21CFR58). The guidelines laid down by other countries, especially members of the European Community, are based upon guidelines developed by the Organization for Economic Development (OECD) in 1980. Guidelines on safety testing and analytical methods issued by the International Conference on Harmonization (ICH) are also reviewed. Special attention is paid to the documentation and the preparations for internal and external inspections and audits.
New drug discovery and development becomes more difficult and more expensive every year.
The larger pharmaceutical companies continue to seek new leads outside of their own research laboratories in order to control R&D costs, or to extend their portfolio. This is particularly true in the biopharmaceutical area, since most traditional pharmaceutical companies have had limited direct experience in this field and prefer to license-in such technology. Alternatively, the smaller biotechnology company may be acquired by the larger partner.
In any drug development program, but especially with the acquisition and further development of any new technology by a major industrial partner, the term 'time to market' becomes all important, since each month lost in the laboratory is a month when the product is not earning revenue to pay back the ever-increasing costs of development and testing. The drug development and testing timeline is being extended by more stringent regulatory requirements, especially in the pre-clinical testing stages. Time to market will be extended, with negative commercial impact, if critical early research work and drug testing has to be repeated under more strictly controlled conditions in order to comply with the GLP regulations.
The Guide to Good Laboratory Practice, 3rd Edition examines the GLP regulations in the United States and other countries in detail, and gives firm guidelines for compliance, using as a basis the GLP requirements published in the U.S.A Code of Federal Regulations, Title 21, Part 58, 2006 Edition (21CFR58). The guidelines laid down by other countries, especially members of the European Community, are based upon guidelines developed by the Organization for Economic Development (OECD) in 1980. Guidelines on safety testing and analytical methods issued by the International Conference on Harmonization (ICH) are also reviewed. Special attention is paid to the documentation and the preparations for internal and external inspections and audits.
Target Audience
This Guide will prove beneficial to the following professionals involved in Pharmaceutical, Biological and Biopharmaceutical Research & Development:
Research Scientists · Technicians · Quality Assurance Personnel · Testing Facility Management · Study Directors · Animal Care Supervisors · And other laboratory professionals concerned with the application of Good Practice guidelines
About the Author
Dr. Alex Kanarek has operated his own consultancy (originally Bio- Development Consulting Services, now AK Consulting) for the past 14 years. Based upon more than 30 years' experience in the biopharmaceutical industry, his consultancy has specialized in technology transfer, biopharmaceutical development and regulatory compliance in development and manufacturing laboratories. Dr. Kanarek is now on the Editorial Advisory Board of the BioProcess International journal
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