What is GDP?
GDP (Good Distribution Practice) is a quality system for the distribution and transportation of medicinal products for human use. GDP ensures that the quality and integrity of medicines is maintained throughout the supply chain from manufacturer to patient.
Simple Analogy: Think of GDP as a chain of custody system for medicines. Just as valuable evidence must be carefully tracked and protected from crime scene to courtroom, GDP ensures medicines are properly stored, handled, and tracked from factory to pharmacy, maintaining their quality every step of the way.
Historical Context: GDP guidelines were developed in response to counterfeit medicines and quality failures in the supply chain. The EU formalized GDP in 2013, and it's now recognized globally.
Key Focus: GDP covers wholesaling, distribution, transportation, and storage of medicines, ensuring they remain safe and effective throughout the supply chain.
Why is GDP Certification Important?
GDP (Good Distribution Practice) is a quality system for the distribution and transportation of medicinal products for human use. GDP ensures that the quality and integrity of medicines is maintained throughout the supply chain from manufacturer to patient. Simple Analogy: Think of GDP as a chain of custody system for medicines. Just as valuable evidence must be carefully tracked and protected from crime scene to courtroom, GDP ensures medicines are properly stored, handled, and tracked from factory to pharmacy, maintaining their quality every step of the way. Historical Context: GDP guidelines were developed in response to counterfeit medicines and quality failures in the supply chain. The EU formalized GDP in 2013, and it's now recognized globally. Key Focus: GDP covers wholesaling, distribution, transportation, and storage of medicines, ensuring they remain safe and effective throughout the supply chain.
Key Insight
Temperature excursions and handling errors can compromise pharmaceutical efficacy and patient safety. GDP certification ensures product integrity throughout the supply chain, meeting regulatory requirements and protecting public health. This is mandatory for pharmaceutical distribution.
Key Principles
The framework is built on fundamental principles that guide implementation and ensure effectiveness:
Systematic Approach
Structured methodology for implementing and maintaining effective management systems.
Continuous Improvement
Ongoing monitoring, measurement, and enhancement of processes and performance.
Stakeholder Focus
Meeting the needs and expectations of customers, regulators, and other stakeholders.
Systematic Approach
Structured methodology for implementing and maintaining effective management systems.
Why it matters
Continuous Improvement
Ongoing monitoring, measurement, and enhancement of processes and performance.
Why it matters
Stakeholder Focus
Meeting the needs and expectations of customers, regulators, and other stakeholders.
Why it matters
Conclusion
GDP is essential for maintaining the quality and integrity of medicines throughout the distribution chain. It ensures that products reaching patients are safe, effective, and authentic, protecting public health and supporting the pharmaceutical supply chain.
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