Good Distribution Practice (GDP)
Good Distribution Practice (GDP) is a set of guidelines ensuring pharmaceutical products maintain quality and integrity throughout the distribution chain.
What is Good Distribution Practice (GDP)?
Good Distribution Practice (GDP) is a quality assurance system for the pharmaceutical supply chain that ensures medicines are stored and transported under appropriate conditions to maintain their quality, safety, and efficacy. GDP is established by the EU Guidelines on GDP for Medicinal Products (2013/C 343/01) and the WHO Technical Report Series.
Key GDP requirements include: qualified storage facilities with validated temperature monitoring, transportation in temperature-controlled vehicles with continuous logging, deviation management procedures, staff training and competency documentation, and a complete audit trail from manufacturer to patient.
Why It Matters
Pharmaceutical products can be rendered ineffective or dangerous by improper storage or transport conditions. GDP ensures that the investment in GMP manufacturing is not wasted by poor distribution practices. Regulators worldwide are increasing scrutiny of distribution chains, making GDP compliance essential for market access.
Frequently Asked Questions
What is the difference between GMP and GDP?
GMP (Good Manufacturing Practice) governs the production of pharmaceuticals. GDP (Good Distribution Practice) governs their storage and transportation after manufacturing. Both are required for a compliant pharmaceutical supply chain — GMP ensures quality during production, GDP ensures quality is maintained until the product reaches the patient.
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