Good manufacturing practice quality organization

Analytical methods and specifications must be established and validated so as to define and control the quality and purity of the raw materials, intermediates and the finished product. For many standard chemical raw materials, the development of specifications will not be necessary as they are already published in US and European pharmacopoeia (for example, standards for water, organic solvents and various excipients). The ultimate objective of these activities is to be able to manufacture the drugs required for clinical trials in accordance with good manufacturing practice (GMP). 

WHO. Quality assurance of pharmaceuticals. A compendium of guidelines and related materials, vol 2, 2nd update ed. Good manufacturing practices and inspection. Geneva World Health Organization 2007. 

Quality control is that part of good manufacturing practice concerned with sampling, specifications, and testing. Its organization, documentation, and release procedures ensure that the necessary and relevant tests are actually carried out, that materials are not released for use and products released for sale or supply, until their quality has been judged to be satisfactory. 

Good Manufacturing Practice (GMP) standards are a further step towards the concept of "total quality". Implementing and maintaining a GMP status requires commitment of the entire organization and constant attention by those who are in charge of quality assurance. Because of the complexity and wide scope of the subject and the amount of paperwork (some translate GMP as "Give Me Paper") extra personnel or external consultants will most likely be required. 

Quality systems requirements for national good manufacturing practice inspectorates, In WHO Expert Committee on Specifications for Pharmaceutical Preparations, Thirty-sixth report. Geneva, World Health Organization, 2002 (WHO Technical Report Series, No. 902), Annex 8. 

Quality Assurance of Pharmaceuticals A Compendium of Guidelines and Related Materials, Vol. 2 Good Manufacturing Practices and Inspection. World Health Organization, Geneva, 1999. 

Quality Assurance Is the sum total of the organized arrangements made with the object of ensuring that products will be of the quality required by their intended use. It is Good Manufacturing Practice plus other factors (e.g. original product design and development). 

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