MTU Library Catalogue

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A compendium of good practices in biotechnology.

Contributor(s): BIOTOL (Project) | Open Universiteit (Heerlen, Netherlands) | University of Greenwich.
Material type: materialTypeLabelBookSeries: Biotechnology by Open Learning (Series): Publisher: Oxford ; Boston : Butterworth-Heinemann, 1993Description: ix, 318 p. : ill. ; 25 cm.ISBN: 0750616008.Subject(s): Biotechnology -- Europe -- Safety measures | Biotechnology industries -- Safety regulations -- EuropeDDC classification: 660.6
Contents:
EC structure and tools / C. Dadomo and J. Greenman -- Directives decision on regulations (and how to find them) / J. Greenman and C. Dadomo -- Biotechnology and the law: summary of some current legislation in force / J. Greenman and D. Dickerson -- Good laboratory practice / H. J. M. van de Donk and M. C. E. van dam-Mieras -- Guidelines for microbial and animal cell cultivation / D. Shaw, J. Greenman and G. Tuijnenburg Muijs -- Safety and the genetic manipulation of organisms / D. Shaw, J. Greenman and G. Tuijnenburg Muijs -- Scientific procedure using animals / H. J. M. van de Donk -- Radiation health and safety / J. Greenman and P. S. Scull -- Patents and biotechnology / T. W. Roberts -- Applying for marked authorisation for medicinal products / H. J. M. van de Donk and C K Leach -- Manufacture and evaluation of medicinal products produced / H. J. M. van de Donk and C. K. Leach -- Regulation of biotechnology in the food industry / C. K. Leach and M. C. E. van Dam-Mieras -- A general comment on the biotechnological production of chemicals other than medicines and food ingredients / C. K. Leach.
Holdings
Item type Current library Call number Copy number Status Barcode
General lending MTU Bishopstown Library Lending 660.6 (Browse shelf(Opens below)) 1 Available 00018438
Total holds: 0

Enhanced descriptions from Syndetics:

This is intended to be a resource file of regulatory affairs in biotechnology that not only backs up the entire BIOTOL series but, also provides a useful tool to anyone involved in biosciences. This book covers all aspects of regulatory affairs from handling techniques and product development guidelines to explanations of legal systems worldwide and facsimilies of relevant EC directives.

"Published on behalf of Open Universiteit and University of Greenwich (formerly Thames Polytechnic).".

Includes bibliographical references and index.

EC structure and tools / C. Dadomo and J. Greenman -- Directives decision on regulations (and how to find them) / J. Greenman and C. Dadomo -- Biotechnology and the law: summary of some current legislation in force / J. Greenman and D. Dickerson -- Good laboratory practice / H. J. M. van de Donk and M. C. E. van dam-Mieras -- Guidelines for microbial and animal cell cultivation / D. Shaw, J. Greenman and G. Tuijnenburg Muijs -- Safety and the genetic manipulation of organisms / D. Shaw, J. Greenman and G. Tuijnenburg Muijs -- Scientific procedure using animals / H. J. M. van de Donk -- Radiation health and safety / J. Greenman and P. S. Scull -- Patents and biotechnology / T. W. Roberts -- Applying for marked authorisation for medicinal products / H. J. M. van de Donk and C K Leach -- Manufacture and evaluation of medicinal products produced / H. J. M. van de Donk and C. K. Leach -- Regulation of biotechnology in the food industry / C. K. Leach and M. C. E. van Dam-Mieras -- A general comment on the biotechnological production of chemicals other than medicines and food ingredients / C. K. Leach.

Table of contents provided by Syndetics

  • Introduction to Regulation and Science Based Industry - Rationale for regulations
  • Protection of workers
  • Protection of the environment
  • Protection of the public
  • Protection of product quality
  • Legal systems and regulatory systems
  • Approaches to and the tools of regulation
  • Structure and relationships between legislative and regulatory bodies
  • Handling Techniques - micro-organisms
  • Laboratory animals
  • Genetic manipulation/rDNA technology
  • Cell line/hybridoma technology
  • Radioactive isotopes
  • Hazardous chemicals
  • Product Development Guidelines - Good laboratory practice
  • Good manufacturing practice
  • Quality control
  • Pre-marketing testing
  • Quality assurance
  • Market authorisation
  • Health and safety at work
  • Waste disposal
  • Classification, labelling and packaging
  • Transportation
  • Catalogue of EC directives and Guidelines including examples of member state related regulations
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