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a surfactant component includes ingredients that modify the water in the system making it suitable for use with several types of water such as hard water, soft water, sulfite contaminated water, rain water, pond water, well water or calcium rich water

PubMed, Cardet, Juan-Carlos, et al

The agency restated fundamental law: You must conduct process validation you are not excused just because an AI did not identify the requirement. The warning letter then emphasized that if Purolea intends to resume manufacturing (it had already ceased production) any AI output must be reviewed and cleared by an authorized human in the Quality Unit ( [39] )

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