Good Distribution Practice (GDP)
What Is Good Distribution Practice (GDP)?
Good Distribution Practice (GDP) refers to a set of quality standards that ensure the proper distribution of medicinal products throughout the supply chain. These guidelines are designed to maintain product integrity, safety, and efficacy from the manufacturer to the end user. GDP compliance is critical for pharmaceutical companies, wholesalers, and logistics providers.
Why does GDP matter for the healthcare sector?
Non-compliance with GDP can compromise drug efficacy and safety, leading to regulatory penalties and health risks. GDP compliance supports traceability, prevents counterfeiting, and upholds regulatory obligations.
What are the key principles of GDP?
- Quality Management System: Formal procedures govern procurement, storage, distribution, and documentation.
- Temperature Control: Essential for temperature-sensitive medicines; cold chain integrity must be maintained.
- Traceability & Documentation: Batch-level tracking and audit documentation are mandatory.
- Training & Audits: Regular staff training and internal audits help maintain compliance and mitigate risks.
Who must comply with GDP?
GDP applies to pharmaceutical manufacturers, wholesalers, logistics providers, and anyone involved in the distribution chain for medicinal products.
How to achieve GDP compliance?
- Implement a robust Quality Management System to ensure quality assurance.
- Use validated temperature-controlled storage and transport equipment to maintain products at the optimal temperature.
- Maintain complete, accurate records for traceability, which track the shelf life of products.
- Conduct ongoing audits and regular staff training, thus maintaining a high standard in quality control.
How does DHL implement GDP?
DHL Health Logistics supports temperature-controlled distribution with end-to-end visibility and specialized infrastructure, such as the new Pharma Hub in Singapore, enabling full compliance with GDP regulations.
Learn more about how the DHL Pharma Hub is taking a clinical approach to set the pace for health sector growth in Asia.
English