The Physical Site of Importation (SOI) plays a pivotal role in the pharmaceutical industry. It ensures Regulatory Compliance, upholding stringent EU/EEA standards. Additionally, SOIs enable Quality Assurance through critical physical inspections, guaranteeing the safety and efficacy of imported medicines. They serve as the final destination for batch certification by Qualified Persons (QPs) and act as secure checkpoints, preventing unauthorised access and tampering during importation. In essence, SOIs are indispensable for regulatory compliance, quality assurance, and security in the pharmaceutical supply chain. Annex 21 to the EU GMP Guide summarizes the requirements related to SOI’s.
In the supply chain, the Physical Site of Importation (SOI) is pivotal in various key stages:
- Physical Importation: SOIs oversee the arrival of medicinal products into the EU/EEA from external sources, managing transportation by air, sea, or land.
- Customs Clearance: SOIs handle customs clearance, guaranteeing compliance with legal mandates, including customs duties and taxes.
- Quality Assurance: Following importation and customs clearance, SOIs may engage in further processing as per regulatory authorisations, preparing products for Qualified Person (QP) certification to ensure quality and safety.
- Quarantine and Storage: Initially, SOIs quarantine imported products, preventing them from entering the market prematurely and designate specific areas for this purpose.
- Record-Keeping: SOIs maintain meticulous documentation, including shipping and temperature records, ensuring continuous traceability and robust quality control across the supply chain.
In summary, the Site of Importation (SOI) is crucial for ensuring imported medicinal products meet regulatory standards, undergo quality control, and are securely managed in the pharmaceutical supply chain before market distribution. Count on MIAS Pharma’s European SOI network and experienced team for efficient importation and leveraging strategic partnerships to deliver cost-effective and seamless solutions.
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