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FDA DEA GMP Master Reference Guide

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Part 11 - Electronic Records; Electronic Signatures - Scope and Application 2003

Parts 210/211 - Drug GMPs

Part 1301 - Sections 71-77 Security and Sections 90-93 Employee Screening

Part 1302 - Labeling and Packaging Requirements for Controlled Substances

Part 1304 - Records and Reports of Registrants

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Part 11 - Electronic Records; Electronic Signatures Audit Check List

Parts 210/211 - Drug GMP Audit Check List

Controlled Substances GMP Audit Check List

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ICH Q9(R1) - Quality Risk Management

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