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Compliance Quiz: ICH Q8, Q9, and Q10

1. According to ICH(R2) Pharmaceutical Development, the basis of a product development design is its quality target product profile, which can include:
2. True or False? According to ICH(R2), once defined, the potential critical quality attributes of a product should not be modified for any reason.
3. According to ICH Q9 Quality Risk Management, “risk ranking and filtering can be used to prioritize manufacturing sites for inspection/audit by regulators or industry.” These methods are helpful when…
4. According to ICH Q9, a Quality System and Quality Risk management are respectively defined as: “The sum of all aspects of a system that implements quality _______ and ensures that quality objectives are met” and, “A systematic process for the assessment, control, _______, and review of risks to the quality of the drug product across the product lifecycle.”
5. According to ICH Q10 Pharmaceutical Quality System, implementation of a Q10 model should result in achievement of three main objectives:
6. According to ICH Q10, “Pharmaceutical Quality System Elements (3.2)”: the Q10 model’s intent is to enhance which elements to promote the lifecycle approach to product quality?
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