International Conference Good Manufacturing Practice

Sheinin, E.B., ICH guidelines. History, Present Status, Intent, presented at the International Good Manufacturing Practices Conference, Athens, GA, 1998. 

Source Adapted from International Conference for Harmonization. Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, ICH Q7,2000. 

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, 2000. 

International Conference on Harmonization (ICH) (2001), Guidance for industry. Q7A good manufacturing practice guidance for active pharmaceutical ingredients, ICH, Brussels, Belgium. 

Levchuk, J. FDA Perspectives on Production of Parenteral Clinical Supplies International Good Manufacturing Practices Conference Mar University of Georgia Athens, GA, Mar 5 1997. 

Important protocols for method validation in the literature have been derived, amongst others, from the Current Good Manufacturing Practice, Code of Federal Regulations, Food and Drug Administration, National Drug Administration, the United States Pharmacopoeia Convention, the American Public Health Association and the International Conference on Harmonization. 

International Conference on Harmonization (1996) Good Clinical Practices. International Federation of Pharmaceutical Manufacturing Associations Geneva. 

EEA, European Economic Area GLP, good laboratory practice GMP, good manufacturing practice ICH, International Conference on Harmonisation IMP, investigational medicinal product SI, statutory instruments. 

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