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Fuku, N., Pareja-Galeano, H., Zempo, H., Alis, R., Arai, Y., Lucia, A., & Hirose, N

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For in-vitro research use only

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This includes: Product release decisions Sterility assurance Environmental monitoring Laboratory testing Stability programs Batch disposition Once confidence in data is lost, FDA must assume that the entire quality system may be compromised

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