Good Manufacturing Practice (GMP)
GMPQuality assurance guidelines ensuring drugs are consistently produced and controlled to meet quality standards. Covers personnel, premises, equipment, documentation, production, and quality control.
Ví dụ
- cGMP (current GMP)
- FDA 483 observations
- EU GMP Annex 1 (sterile products)
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Quality assurance guidelines ensuring drugs are consistently produced and controlled to meet quality standards. Covers personnel, premises, equipment, documentation, production, and quality control.