Good Manufacturing Practice (GMP)

GMP
Regulatory

Quality assurance guidelines ensuring drugs are consistently produced and controlled to meet quality standards. Covers personnel, premises, equipment, documentation, production, and quality control.

Примеры

  • cGMP (current GMP)
  • FDA 483 observations
  • EU GMP Annex 1 (sterile products)

Знаете ли вы?

Quality assurance guidelines ensuring drugs are consistently produced and controlled to meet quality standards. Covers personnel, premises, equipment, documentation, production, and quality control.