Analysis and Control of Variation: Quality Risk Management and Variability Reduction | IVT

KEY POINTS DISCUSSED

The following key points are discussed:

• Quality risk management (QRM) is a key part of quality by design.
• Guidance for QRM is provided by ICH Q9.
• QRM is intimately linked with the pharmaceutical control strategy for a product.
• Risks represent the potential for variability in the process or product.
• QRM can help reduce variability in the following two ways:
• By ensuring the initial control strategy does not lead to high levels of variability. 
• By helping the quality systems work better when the process is in operation and product is being delivered to the patient.
• Just as there will always be some level of variability in a process or product, there will always be some risks associated with the process or product.