Chapter 1 Good Manufacturing Practices in Over-the-Counter Drug Product Manufacturing 3 I. Buildings and Facilities( 21 CFR 211, Subpart C) 3 III. Equipment( 21 CFR 211, Subpart D) 3 IV. Components and Product Containers( 21 CFR 211, Subpart E) 4 V. Production and Process Controls( 21 CFR 211, true inter-operation) 4 A. Critical Manufacturing thoughts( 21 CFR) 4 B. Equipment Identification( 21 CFR) 5 C. In-Line and Bulk Testing( 21 CFR) 5 D. Actual Yield( 21 CFR) 5 E. Tablet and Capsule Products 5 G. Environmental Controls 6 5. Containers and Closures 6 H. Retesting for Sterility 8 2.
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