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A Risk-based predictive approach to reduce the cleaning validation requirement by 50%.

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QUOTE FROM A 483 LETTER

"This worst case selection should be based on the solubility and difficulty of cleaning and the calculation of residue limits based on potency, toxicity, and stability."

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Data Integrity

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Pereodic Monitoring

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Automated Reporting

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A Risk-based predictive approach to reduce the cleaning validation requirement by 50%