GDP — Good Distribution Practice
Protecting Product Integrity Across the Global Supply Chain
In a borderless pharmaceutical market, the quality of a medicinal product is only as robust as its weakest link during transit. Whether moving life-saving biologics under strict cold chain requirements or high-volume APIs across continents, Good Distribution Practice (GDP) is the bedrock of patient safety. Arirex provides the senior technical oversight required to ensure your logistics partners maintain the same quality standards as your manufacturing suites.
Core Technical Audit Focus
Cold Chain & Temperature Management
- Thermal Mapping: Verification of warehouse and transport vehicle mapping studies (Summer/Winter worst-case) in alignment with USP <1079> and WHO TRS 1025 Annex 7.
- Active & Passive Systems: Auditing the qualification of thermal packaging (PCM), refrigerated containers, and real-time data logging monitoring.
- Cryogenic & Ultra-Low Logistics: Specialized oversight for Cell & Gene Therapy (CGT) transport requirements.
3PL & Logistics Handler Oversight
- Subcontractor Verification: In-depth auditing of 3PL/4PL providers, freight forwarders, and airline handlers to ensure technical quality agreements are followed.
- Last-Mile Integrity: Verification of delivery protocols to pharmacies, hospitals, and clinical sites.
- Returned & Falsified Medicines: Rigorous assessment of security protocols for return handling and lineage verification.
Regulatory Standards & References
- EU GDP: European Commission Guidelines on Good Distribution Practice (2013/C 343/01).
- WHO: Technical Report Series for Good Storage and Distribution Practices (Annex 7).
- United States: USP <1079> and the Drug Supply Chain Security Act (DSCSA) track-and-trace requirements.
- PIC/S: GDP Guide (PE 011) for international regulatory cooperation.
The ARIREX Deliverable
Every GDP audit concludes with a technical report prioritizing logistics risks, cold chain gaps, and quality management system vulnerabilities. We provide the "Peace of Mind" that your medicinal products arrive at their destination as effective and safe as they were when they left the factory.