ccce97e812365c9f754bf854b5b3484b799ca0ea152711ec5ea314b6adb8711b
draft
contextual
prescribed

Compliance with the Global CAPA program is mandated by 21 CFR Part 211.180/192 and 21 CFR Part 820.100, which govern records and reports of drug product failure investigations and quality system regulation for corrective and preventive action respectively.

Supporting contexts

Rationale

Compliance is mandated by: 21 CFR Part 211.180/192: Records and reports of drug product failure investigations. 21 CFR Part 820.100: Quality System Regulation for Corrective and Preventive Action. Compliance is mandated by.

legacy import — synthesised from supporting_context_primary

Effective from: 4/28/2026, 12:54:59 PM

History