Quality management Good manufacturing

EU GMP Chap. 1 on Pharmaceutical Quality System highlights the inter-relation of the basic concepts of Quality Management, Good Manufacturing Practice and Quality Risk Management and emphasises their fundamental importance to the production and control of medicinal products. 

Good manufacturing practice is that part of the quality management system (QMS) that is concerned with the production and quality control of medicinal products (drugs) for human and veterinary use. It includes documentation, personnel training, facility, equipment, and process controls for the manufacture of pharmaceuticals. 

Continuous quality improvement (CQI) is aphilosophy of continual improvement of the processes associated with providing a good or service that meets or exceeds customer expectations (Shortell et al., 1998). CQI, which was first employed in the manufacturing field, was introduced into health care by Berwick and Leape (1999). [CQI has been referred to as quality improvement process, total quality management, and total quality control (Lohr, 1990b).]... 

Final Good Manufacturing procedure / Quality Management System audit... 

EC (1998b), Quality management, In The Rules Governing Medicinal Products in the European Union, Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, vol. 4, Eudralex. Available at http //pharmacos.eudra.org/ F2/eudralex/vol-4/pdfs-en/caplen.pdf (accessed October 2006). 

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