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ROS serves as both a pro-cancer signalling molecule and an executor of cell death, making it a critical node linking tumour metabolism, epigenetic regulation, and microenvironmental modulation
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The FDA keeps citing firms that fail to demonstrate: Insufficient evidence of process control Validation executed with incomplete protocols Cleaning validation skipped or outdated CAPAs closed without demonstrating actual effectiveness This is where scientific justification and documentation need to work hand in hand
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