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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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NAC is not found in food sources, but high protein foods such as eggs, wheat, broccoli and poultry are good sources of cysteine