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Cleaning Validation Glossary

Product Quality

Measures ensuring product meets standards

Product quality measures that product meets standards. Examples include identity, strength, and purity. Overall, product quality helps ensure patient safety and that the treatment is consistently effective. FDA 211,110(a) states that all processes should include in-porcess control procedures to assure final product quality. During cleaning validation, a risk assessment should be conducted to minimize the risks of cross contamination that could impact product quality.

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