QUALITY RISK MANAGEMENT – CAPA TO PREVENT POTENTIAL QUALITY ISSUES
Keywords:
Quality risk Management, FMEA, RPN, CAPA, ICHAbstract
In the pharmaceutical industry there are number of risks and failure involved in each and every pharmaceutical product
throughout the life cycle. Risk are managed in our day to day life and ensure that preventive measures are taken to avoid
any hazards in our life, similarly quality risk management is the tool using which potential quality issues can be avoided to
occur for the pharmaceutical products throughout the lifecycle of the product. The principle of QRM can be applied
proactively or retrospectively at many stages of pharmaceutical quality such as product development, technology transfer,
production, pharmacokinetic evolution, distribution, inspection, validation, submission/review process and life cycle
management in product development. It finds useful application in selection of raw materials, solvents, excipients, packaging
and labelling materials, formulation development, process development and process improvement. This article discusses
general principles and several tools for risk management which can be used successful to identify the potential quality
issues. The quality risk management theory and applications for controlling the risk to pharmaceutical quality has identified
various potential quality issues and allowed the pharmaceutical industry to manufacture the quality and safe products for
the patients.
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