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类别: QUALITY SYSTEMS
良好生产规范(GMP)
确保医疗器械按照质量标准持续生产和控制的法规和指南。在美国，器械GMP编入FDA 21 CFR第820部分（质量体系法规）。
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
Expanded process notes below are currently maintained in English; the short definition above is localized. See our 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 良好生产规范(GMP) across 27 authorities in real time.
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