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MVS Pharma GDP-compliant warehouse overview: The EU GDP Guidelines highlight a simple truth: even the best medicines can only remain safe and effective when stored under the right conditions. The premises and equipment supporting pharmaceutical distribution must therefore operate with precision and reliability. At MVS Pharma GmbH, our temperature-controlled warehouse and qualified equipment reflect this principle, ensuring consistent environmental control and protection of every product in our care.
EU GDP Expectations for Premises and Equipment
EU GDP requires that pharmaceutical premises be clean, well-organized, and designed to protect medicinal products from contamination, mix-ups, and environmental influence. Storage areas must be spacious, secure, and temperature-controlled, with dedicated zones for receiving, quarantine, storage, and dispatch. Equipment involved in environmental control and product handling must be qualified, calibrated, and maintained to ensure consistent performance.
GDP emphasizes three foundational principles:
- Environmental suitability – premises must maintain conditions appropriate for product quality.
- Equipment reliability – tools used for monitoring, storage, and transport must be qualified and routinely maintained.
- Documentation compliance – temperature records, calibration certificates, and maintenance logs must be readily accessible for inspection.
MVS Pharma GDP-Compliant Warehouse: Infrastructure
MVS Pharma GmbH operates a Temperature-Controlled Pharmaceutical Warehouse, designed specifically for the safe handling and storage of medicinal products. The premises ensure full compliance with regulatory storage requirements, supported by controlled access, cleanliness zoning, and strict organizational structure.
Medicinal products are stored strictly according to their labeled storage conditions. Food, beverages, and personal medicines for staff are strictly prohibited within the storage area to prevent cross-contamination risks and to maintain a GMP-compliant environment.
The warehouse maintains a controlled temperature between 15°C and 25°C, ensuring that all medicinal products remain within their defined stability range. The facility also maintains relative humidity below 60%, protecting packaging materials and moisture-sensitive products.
Advanced Temperature and Humidity Control System
MVS Pharma’s warehouse is equipped with a state-of-the-art heating and air-conditioning system, specially configured for pharmaceutical storage. This system maintains stable environmental conditions through automated adjustments and continuous airflow management.
Environmental monitoring is performed through online smart data loggers, offering real-time visibility and automated alerts in case of deviations. This system allows the Warehouse Manager to detect any temperature excursions immediately, ensuring fast corrective actions and fully traceable digital records.
In addition to continuous automated monitoring, the Warehouse Manager records temperature values daily on the Daily Temperature Monitoring Log, creating a hybrid of online traceability and human oversight – an approach favoured by regulators for its robustness.
Equipment Qualification, Calibration, and Maintenance
All equipment that has an impact on product quality – such as HVAC units, thermometers, and data loggers – is managed under a structured qualification lifecycle. MVS ensures that critical equipment:
- undergoes initial qualification (IQ/OQ/PQ when applicable)
- is calibrated annually by approved service providers
- is maintained according to a planned maintenance schedule
- is assessed for performance during internal audits and management reviews
Calibration and maintenance documentation forms part of the Digital QMS, ensuring transparent and easily retrievable records for inspections.
Operational Safety and Product Protection
To maintain orderly workflows and prevent mix-ups, the warehouse layout includes distinct areas for goods receiving, quarantine, approved storage, and dispatch. Access is restricted to authorized personnel, enhanced by surveillance and alarm systems. Clear labeling, housekeeping standards, and pest-control measures ensure hygienic and compliant storage conditions.
The end-to-end flow, from receipt, temperature-controlled storage, picking, packing, and dispatch, is designed to minimize handling risks and preserve product identity and traceability at every step.
Conclusion
At MVS Pharma GmbH, we prioritize a secure and compliant storage environment that ensures every medicinal product remains protected and stable. Through continuous improvements to our facilities, monitoring tools, and equipment maintenance programs, we consistently meet EU GDP expectations and demonstrate our lasting commitment to patient safety.
