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Cleaning Validation Glossary

Impurity Levels

Amount of unwanted substances

Impurity levels are the amount of unwanted substances present in your product. According to ICH Q3A, acceptance criteria for the impurity limit should be based on safety data as many impurities can be toxic to patients at a certain concentration. During cleaning validation it is important to understand how previous product residues and cleaning agent residues impact the overall impurity levels in the current product being produced.

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