Good Clinical Practices (GCP) are regulations set by the United States Food and Drug Administration (FDA) that establish minimum quality requirements for conducting clinical studies that assess the safety and efficacy of FDA-regulated products. These studies are typically used to support research or marketing applications for new treatments and medical products.
GCP regulations appear throughout Title 21 of the Code of Federal Regulations (CFR), with key parts including:
- Part 312 for investigational new drug applications (INDs)
- Part 814 for premarket approval (PMA) of medical devices
- Part 820 for quality system regulations (QSR) for medical devices
For maintenance management purposes, GCP regulations include standards for facility conditions, maintenance, and calibration records for critical trial-specific equipment.
The International Council of Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) provides the internationally recognized guidelines for Good Clinical Practices in the ICH E6 standard.
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