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Author
Parrilla Rodríguez, Carlos
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Abstract
Quality risk management is a fundamental part of an effective pharmaceutical quality system in the pharmaceutical industry, which guarantees product quality through a proactive approach to identifying potential problems.
In this project, an analysis of the ICH Q9 Quality Risk Management guide has been carried out. In turn, a comparison of the current ICH Q9 guideline is carried out with the draft of the revised ICH Q9 guideline (R1) Quality Risk Management.
The ICH Q9 guide is a document aimed at risk management in the different aspects that encompass pharmaceutical quality. This guide offers principles, a procedure and a methodology for the management of risks that can occur during pharmaceutical development and manufacturing.
The ICH Q9 (R1) draft guideline is in phase 3 of the review process and is currently being evaluated by regulatory authorities and pharmaceutical industry associations. Four main areas for improvement are identified in the draft that are intended to bring clarity and understanding to quality risk management.
Key words: ICH, Q9, Quality Risk Management.
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