Publisher's Synopsis
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.
