The scope and definitions of drug good manufacturing practice regulations 21 CFR 211 and the additional requirements for Europe of the Eudralex orange guide chapter 4
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1.0 - Drug Definitions used in 21 CFR 211
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1.1 - Quality Management System (QMS) Overview
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1.2 - Good Manufacturing Practice GMP
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1.3 - Quality Control Overview
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1.4 - Product Quality Review (PQR)
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1.5 - Risk Assessment or QRM
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1.6 - Good Distribution Practice GDP
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1.7 - Self Inspection via Internal Audits
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