GMP & GDP: Drug Storage and Transportation as a Strategic Quality Function
Pharmaceutical logistics is no longer just about moving products — it’s about protecting quality. The recently updated USP <1079> guidance makes it clear that GMP obligations extend well beyond manufacturing. Every handoff, route, and storage location must be risk-assessed, qualified, and monitored to preserve product integrity. This blog explores how risk-based thinking, cold chain validation, and supplier qualification underpin compliant pharmaceutical storage and transport — and how Rephine helps companies embed these principles into their Quality Management Systems.
Quality doesn’t stop at the factory gate.
Ensuring GMP-compliant storage and transportation requires risk-based control, robust qualification, and a quality culture that spans the entire supply chain.
Why Drug Storage and Transportation Matter for GMP Compliance
In today’s complex and global pharmaceutical supply chains, ensuring that drug products maintain their quality during storage and transportation is not just a logistics challenge — it’s a critical GMP obligation.
The chapter USP <1079> lays out a risk-based approach that emphasizes that the quality of a product does not end at the manufacturing site — it continues all the way to the point of administration.
USP — Key Principles for Pharmaceutical Storage and Transport
USP <1079> defines the storage and transport of drug products as a process vulnerable to multiple risks — from temperature excursions to documentation gaps, human errors, and supply chain fragmentation.
A few highlights:
- Excursions outside of label conditions may be allowed, but only with scientific justification and stability data.
- Risk management should rely on tools like FMEA, HAZOP, and HACCP.
- Mitigation strategies must address:
📄 Documentation • 🧠 Training • 🛠️ Resources • ✅ Qualification & Validation
These principles must be embedded within a mature Pharmaceutical Quality System (PQS) to ensure product quality and patient safety.
The Real-World Challenges in Pharma Storage and Distribution
In practice, many companies still treat logistics as a separate domain, disconnected from QA and PQS strategy. This creates blind spots in:
- Cold chain risk visibility
- Supplier and 3PL qualification
- Deviation management
- Training across the distribution network
With increasing regulatory pressure and growing complexity of supply chains, quality oversight must extend beyond the factory gate.
How Quality-Mature Pharma Companies Manage Storage and Transport Risk
Organizations with a high level of Quality Management Maturity (QMM):
- Integrate logistics controls into their QMS.
- Perform data-driven risk assessments on transport lanes.
- Validate temperature-sensitive routes.
- Set up robust quality agreements with all supply chain partners.
- Ensure real-time monitoring and traceability across the chain.
Create a culture of ownership that spans internal and external teams.
How Rephine Helps Build GMP-Compliant Storage and Transport Strategies
At Rephine, we work with pharmaceutical and biotech companies to ensure GMP-compliant storage and transportation strategies.
Our approach includes:
✅ Audits and qualification of 3PLs and distributors
✅ Risk mapping based on USP <1079> and ICH Q9
✅ SOP development and quality agreements
✅ Training programs for QA, logistics and supply partners
✅ Integration of logistics into PQS and QMM frameworks
From global manufacturers to mid-sized firms, we help embed transport quality as part of your strategic quality roadmap.
Extending Quality Culture Beyond the Factory Gate
If your supply chain is global, your quality culture must be too.
USP <1079> is not just a compliance guide — it’s a call to extend your QMS mindset across the full distribution chain.
Managing temperature isn’t enough — managing risk is essential.
Dr. Eduard Cayón
CSO (Chief Scientific Officer)
About the Author:
Dr. Eduard Cayón is the Chief Scientific Officer (CSO) at Rephine, a global leader in GxP compliance and quality assurance.
We don’t just deliver audits or consultancy services — we partner with clients at every stage of their quality journey, offering end-to-end solutions that empower confidence and compliance.
With over 25 years of experience, Rephine has built an enviable reputation as the gold standard in the industry operating from four primary locations: Stevenage in the UK, Barcelona in Spain, India, and Shanghai in China.
Dr. Cayón, who holds a Ph.D. in Organic Chemistry, is a deeply experienced pharmaceutical industry consultant and auditor.
He is dedicated to supporting pharmaceutical, biotech, and medical device companies in meeting the highest standards of manufacturing and supply chain integrity.
