Learn ICH Guideline II Risk Assessment II ICH-Q9 II Pharma Interview II Guidance for Quality Risk Management II ICH Q9 For Pharmaceuticals II Quality Risk Management in Pharmaceuticals.
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In this Video, we are going to take you through ICH-Q9 Pharmaceuticals Quality Risk Management.
PRINCIPLES OF QUALITY RISK MANAGEMENT:
Two primary principles of quality risk management are:
• The evaluation of the risk to quality should be based on scientific knowledge
and ultimately link to the protection of the patient; and
• The level of effort, formality and documentation of the quality risk
management process should be commensurate with the level of risk.
Key concept of Risk management includes:
* Risk Assessment.
* Risk Control.
* Risk Review.
* Risk Communication.
* Risk Management throughout the Product Lifecycle.
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The ICH Q9 guideline serves as a framework for pharmaceutical companies to proactively identify and manage risks associated with their products and processes.
Click to View / learn Good Manufacturing Practices (GMP) in pharmaceuticals : [ Ссылка ]
