Current Good Manufacturing Practice (cGMP)

cGMP regulations (21 CFR Parts 210 and 211 for drugs; Part 820 for devices) establish minimum requirements for methods, facilities, and controls used in manufacturing, processing, and packaging of pharmaceutical products. The "current" in cGMP reflects the expectation that manufacturers adopt up-to-date technologies and systems — what was acceptable a decade ago may not meet current standards.

Key cGMP requirements include: written procedures (SOPs) for all critical processes; validation of manufacturing processes and analytical methods; personnel training documentation; equipment qualification and maintenance records; batch record documentation; and out-of-specification (OOS) investigation procedures. cGMP violations are the most common cause of FDA warning letters and consent decrees. Document intelligence helps quality teams audit cGMP compliance documentation across manufacturing sites, identify procedural gaps, and retrieve evidence during FDA inspections.