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The Three Operating Systems of Pharmaceutical Quality: How FDA, EU, and Japan’s cGMP Inspections Actually Work
Let me first define what we are really talking about when we say “cGMP inspection.” We are not talking about checklists. We are not talking about auditors with clipboards walking through factories. We are talking about a truth-telling mechanism — a system designed to answer one question: does this company actually make what it says it makes, the way it says it makes it? Every regulatory body on earth asks the same question. But each one has built a completely different machine to find the answer. The machine reveals everything about what that regulator values, what it fears, and what it assumes about human nature. FDA: The Punishment-Optimized Machine The…


