GDP — Good Distribution Practice
Safeguarding Supply Chain Integrity & Product Quality During Transit
Good Distribution Practice (GDP) ensures that the high level of quality established during manufacturing is maintained throughout the entire distribution network. Arirex provides comprehensive audits of wholesalers, distributors, and logistics providers to verify that your products are handled, stored, and transported under required conditions.
Our GDP Audit Scope
Our MDR/IVDR specialists ensure your documentation withstands Notified Body review under the strengthened EU regulatory landscape.
Inline references: MDR Annex II/III, IVDR Annex II/III.
Risk Management & Design Control Auditing
- Assessment of product lifecycle integration, design verification/validation, and risk traceability from concept to post market.
- Inline references: ISO 14971:2019, FDA Design Control (21 CFR 820.30).
Software Validation & Cybersecurity Auditing
- Evaluation of software lifecycle documentation, validation evidence, cybersecurity controls, and development processes for software driven and digital health devices.
- Inline references: FDA Software Validation Guidance, IEC 62304.
Audit Deliverables
Every audit engagement includes structured, actionable outputs such as:
- Full device lifecycle audit report
- Supplier / subcontractor qualification and verification
- Gap analysis with direct regulatory citations
- PMS, vigilance, and UDI system assessments
- Technical documentation review & remediation roadmap
All deliverables are designed for implementation clarity and regulatory inspection readiness.
Regulatory References
Arirex auditing frameworks align with globally recognized standards, including:
- ISO 13485:2016
- ISO 14971:2019
- MDSAP Audit Model
- FDA: 21 CFR 820, 21 CFR 11
- EU MDR 2017/745 & IVDR 2017/746
- IEC 62304
- Health Canada, TGA, PMDA, ANVISA regulations