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類別: QUALITY SYSTEMS
良好生產規範(GMP)
確保醫療器材按照品質標準持續生產和控制的法規和指南。在美國，器材GMP編入FDA 21 CFR第820部分（品質體系法規）。
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 良好生產規範(GMP) across 27 authorities in real time.
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