PEC-20-10 UNDERSTANDING ANSI/ AAMI/ISO 14971:2007 & ICH Q9 – QUALITY RISK MANAGEMENT
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Ing. Carlos Urrutia
The manufacturing and use of drug products, including its components, necessarily entail some degree of risk. It is important to understand that product quality should be maintained to the quality of the drug product lifecycle such that the attributes that are important to the quality of the drug product remain consistent with those used in the clinical studies. An effective quality risk management approach can further ensure the high quality of the drug product to the patient issues during development and manufacturing.
Furthermore, the use of Quality Risk Management can improve the decision making if a quality problem arises.
Risk Management is a much about identifying opportunities as avoiding or mitigating losses. This process may be applied at all stages in the life of a product or process. Risk is uncertainty of outcome, and good Risk Management allows an organization to effectively constrain threats, minimize losses and maximize opportunities.