Bars

Major GMP Guidlines

• FDA Regulation and Guidelines

• 21 CFR Part 210 Current Good Manufacturing Practice

• 21 CFR Part 211 Current Good Manufacturing Practice

• 21 CFR Part 11 Electronic Records, Electronic Signatures

• 21 CFR Part 600 Biological Products: General

• 21 CFR Part 606 Current Good Manufacturing Practice for Blood and Blood Components

• 21 CFR Part 610 General Biological Products Standards

• 21 CFR Part 800 Medical Devices - General

• 21 CFR Part 820 (Quality System Regulation)