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European Union Directive inspections

Within the European Union, the European Commission (EC) has codified the GLP requirements for medicinal products in the Introduction and General Principles chapter of Directive 2003/63/EC [31]. Within this document it is stated that nonclinical (pharmacotoxicological) studies must be carried out in conformity with the provisions related to GLP laid down in Council Directives 87/18/EEC3 on the harmonization of regulations and administrative provisions relating to the application of the principles of GLP and the verification of their application for tests in chemical substances and 88/320/EEC4 (corrigenda 1, 2, and 3) on the inspection and verification of GLP [32,33], The OECD principles have been adopted by the European Union and published, in their revised form, in the appendix to Directive 2004/10/EC [32], The GLP Web site of the EC contains detailed reference information and links for member state GLP compliance [34],... [Pg.833]

The Water Framework Directive (European Union, 2010) aims at achieving a good ecological and chemical status of surface water by 2015. The Industrial Emissions Directive (lED) 2010/75/EC, minimizes the environmental impact of industrial sources. Permits provided to companies need to concern the whole environmental impact of the plant they also need to be based on the best available techniques and are subject to mandatory inspections. [Pg.45]


See other pages where European Union Directive inspections is mentioned: [Pg.168]    [Pg.300]    [Pg.810]    [Pg.80]    [Pg.193]    [Pg.367]    [Pg.38]    [Pg.837]    [Pg.837]    [Pg.2394]    [Pg.2395]    [Pg.165]    [Pg.638]    [Pg.15]    [Pg.387]    [Pg.920]    [Pg.304]    [Pg.283]    [Pg.990]    [Pg.12]    [Pg.695]    [Pg.469]   
See also in sourсe #XX -- [ Pg.549 ]




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European Union Directive

European directives

Inspections European

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