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J., and Dong, D
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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The following buffers containing 100 mM NaCl, 1 mM EDTA and 100 mM of buffering compound were used to make a pH scale: 5 (sodium acetate), 6 (MES), 7 (sodium phosphate), 8 (Tris-HCl), 8.5 (sodium tetraborate), 9 (sodium carbonate), 10 (CAPS), 11.3 (sodium phosphate)
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Aroda VR, Edelstein SL, Goldberg RB, Knowler WC, Marcovina SM, Orchard TJ, et al
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