A compendium of good practices in biotechnology

著者

書誌事項

A compendium of good practices in biotechnology

（Biotechnology by Open Learning）

Butterworth-Heinemann on behalf of Open Universiteit and University of Greenwich (formerly Thames Polytechnic), 1993

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注記

Includes index

内容説明・目次

内容説明

Good practices in biotechnology are extensive and far reaching. Some issues are product or process specific, other are more generic. This text brings together a discussion of many of the key issues and regulations thereby providing a valuable resource for those practising, or intend to practice, in biotechnology. It begins by providing an overview of the administrative organisation and tools of the EC and its member states as a backdrop to a description of key Directives and Guidelines. Topic coverage includes good laboratory and manufacturing practices, safety issues of gene manipulation, the cultivation of micro-organisms, the use of animals, procedures using radioactive isotopes, market authorisation for medicinal products and food ingredients and intellectual property rights. Primarily designed as a reference source, the added commentaries and distillation of key elements provide a valuable back-up to the technical texts of the BIOTOL series.

目次

  • 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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