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A manufacturer can choose to operate under cGMP regulations under 21 CFR 210 and 211 for its single-entity or co-packaged drug -device combination product. The
A manufacturer can choose to operate under cGMP regulations under 21 CFR 210 and 211 for its single-entity or co-packaged drug -device combination product. The manufacturer would also have to comply with all the provisions of which of the following: Group of answer choices Quality System Regulations at 21 CFR 820, including 820.20, 30, 50, 100, 170, and 200 Quality System Regulations at 21 CFR 820, only including 820.20, 30 and 50 Biologics 21 CFR 601.2, and 25 Biologics 21 CFR 601.25 only
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