Under the EU framework, manufacturers holding an MIA are authorised to distribute medicinal products. While there is no explicit requirement to appoint an RP in the same way as a wholesale distributor, this does not remove their obligations to ensure distribution activities comply with current GDP guidelines.
Regulators still expect clearly defined ownership, oversight and governance for GDP compliance within the pharmaceutical quality system. A manufacturer may have an excellent GMP system yet still expose patients and products to significant risks if distribution activities are poorly governed. Manufacturers should be able to demonstrate who is responsible for:
- GDP oversight.
- Management of storage and distribution
- Complaints, recalls and suspected falsified medicines
- GDP training, deviations and CAPAs
In many MIA-holding organisations, GDP oversight becomes absorbed into quality management activities. This absorbed role can work effectively where GDP oversight remains genuinely active and not secondary to manufacturing priorities and where:
- Operations are smaller or less complex
- Distribution activities are limited
- The quality system is mature
- Responsibilities are clearly structured
- Adequate time allocation exists
For larger manufacturers with complex global supply chains, cold chain products or extensive use of third-party logistics providers, relying solely on general QA oversight may be difficult to justify from a risk-management perspective. When GDP becomes an add-on responsibility, important oversight activities can receive insufficient attention.
The key issue is accountability. A named GDP-lead, whether within QA, Supply Chain Quality, or a dedicated GDP function provides:
- Ownership of distribution compliance activities
- Oversight of transportation qualification and monitoring
- Management of GDP-related deviations and CAPAs
- Coordination of recalls and returns
- Oversight of third-party logistics providers
- Inspection readiness for GDP-related requirements.
The question is not whether an MIA holder needs a formal GDP RP, but whether GDP activities have clear ownership and effective oversight.
As pharmaceutical supply chains become increasingly complex, ensuring dedicated attention to GDP is less about regulatory titles and more about protecting product quality, maintaining compliance, and ultimately, safeguarding patients.
