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CATEGORY: QUALITY SYSTEMS
Good Manufacturing Practice (GMP)
Regulations and guidelines ensuring medical devices are consistently produced and controlled according to quality standards. In the US, GMP for devices is codified in FDA 21 CFR Part 820 (Quality System Regulation).
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
WHEN IT APPLIES
Good Manufacturing Practice for devices is embodied in quality system rules ensuring consistent production and control—FDA historically 21 CFR 820 (transitioning toward QMSR alignment with ISO 13485 concepts).
PROCESS / STEPS
- Map manufacturing processes and critical controls.
- Document procedures, training, and environmental controls.
- Validate processes where required; manage CAPA and complaints.
- Prepare for inspection readiness.
EXAMPLES
- Sterile manufacturing lines require validated sterilization and environmental monitoring under GMP expectations.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to Good Manufacturing Practice (GMP) across 27 authorities in real time.
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