The Pharmaceutical Industry Has Been Privatized

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The pharmaceutical industry has been profitable; however, it has been inefficient and the quality of products has been low (Plumb, 2013). Many areas of business and government utilize risk management principles to ensure quality. The International Conference on Harmonisation (ICH) Quality Risk Management guideline (Q9) (2005) states that “it is commonly understood that risk is defined as the combination of the probability of occurrence of harm and the severity of that harm”. The pharmaceutical industry has recognized the importance of quality systems and that quality risk management is an important component of effective quality systems (ICH, 2005). A quality system as defined by ICH Q9 (2005) is the “sum of all aspects of a system that implements quality policy and ensures that quality objectives are met”.
The ICH Pharmaceutical Quality System guideline (Q10) (2008) provides a comprehensive model for a pharmaceutical quality system that is effective, complements ICH Q8 and ICH Q9, is based on International Standard Organization (ISO) quality concepts and includes applicable Good Manufacturing Practice (GMP) regulations. ICH Q10 is a model that can be implemented during the different stages of a product 's lifecycle (ICH, 2008). When integrated into quality systems, quality risk management supports decisions that are based on science and are practical (ICH, 2005). With regard to pharmaceuticals, although the risk to quality is only one component of the overall risk involved
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