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


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.

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