GMP Publications - Code of Federal Regulation Handbooks by the FDA

FDA DEA GMP Master Reference Guide

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US FDA Title 21 CFR

Part 11 - Electronic Records; Electronic Signatures
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
Part 1305 - Orders for Schedule I and II Controlled Substances
Part 1316 - Administrative Functions, Practices and Procedures
Part 1317 - Disposal

 Auditor’s Check Lists

Part 11 - Electronic Records; Electronic Signatures Audit Check List
Parts 210/211 - Drug GMP Audit Check List
Controlled Substances GMP Audit Check List

 Guidance

ICH Q9 - Quality Risk Management

 






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