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U.S. Code of Federal Regulations Part 211 Current Good Manufacturing Practices for Finished Pharmaceuticals

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Health Canada Good Manufacturing Practices Guide for Drug Products (GUI-0001)

MHRA GxP Data Integrity Definitions and Guidance for Industry

U.S. FDA Bioresearch Monitoring (BIMO) Compliance Programs

U.S. Code of Federal Regulations Part 11 Electronic Records; Electronic Signatures

EudraLex Volume 4 – Good Manufacturing Practice (GMP) Guidelines

U.S. FDA Regulations Relating to Good Clinical Practice (GCP) and Clinical Trials

U.S. Code of Federal Regulations Part 210 Current Good Manufacturing Practice In Manufacturing, Processing, Packing, Or Holding Of Drugs; General

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