Quality management, Good Manufacturing Practice

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. 

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). 

Training in Good Manufacturing Practices should be in accordance with written programs approved by the Production Manager and the Quality Control Manager. 

In batch-oriented quality management systems, such as good manufacturing practice (GMP), the batch number of an active substance or a product is the main index variable, where the entire information about sourcing of materials, manufacturing, analysis (control), packaging, and distribution is attached. 

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. 

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