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MVS Pharma controlled storage conditions overview: Proper storage is a continuous and critical activity under the EU Good Distribution Practice (GDP) framework. Even after successful receipt and inspection, medicinal products remain vulnerable to environmental conditions, improper handling, and inadequate controls. EU GDP, therefore, requires wholesalers to maintain storage conditions that preserve product quality throughout the entire holding period. At MVS Pharma GmbH, storage operations are designed to ensure stability, traceability, and compliance at all times.
EU GDP Expectations for Storage Operations
EU GDP requires that medicinal products be stored under conditions consistent with their labeling and regulatory requirements. Storage facilities must be designed, maintained, and monitored to prevent deterioration, contamination, mix-ups, and unauthorized access. Environmental conditions must be continuously monitored, deviations investigated, and corrective actions implemented where necessary.
Key GDP principles for storage include:
- controlled temperature and humidity
- continuous environmental monitoring
- segregation by stock status
- secure access
- documented cleaning and pest control
- traceability and stock rotation
Controlled Storage Conditions at MVS Pharma
- Temperature and Humidity Control
MVS Pharma GmbH operates a temperature-controlled pharmaceutical warehouse where medicinal products are stored strictly within 15°C to 25°C, in accordance with labeled storage conditions. Relative humidity is maintained below 60%, protecting products and packaging from moisture-related risks.
Environmental conditions are continuously monitored using online smart data loggers. The system is supported by an automated alarm mechanism that alerts responsible personnel immediately in case of temperature or humidity excursions. The Warehouse Manager reviews and records environmental data on a daily basis, ensuring constant oversight.
- Deviation Management for Environmental Excursions
Any deviation from defined environmental limits is documented and investigated in accordance with established SOPs. A root cause analysis is performed, and the Responsible Person (RP) evaluates the potential impact on product quality. Where required, corrective and preventive actions (CAPAs) are implemented to prevent recurrence.
Storage Organization and Segregation
- Segregation by Stock Status
Products are clearly segregated according to their status:
- Quarantined
- Approved / Released
- Rejected / Blocked
Each status is visually identifiable through labeling and controlled storage locations. This prevents mix-ups and ensures that only released products are available for picking and dispatch.
- Storage According to Product Requirements
Medicinal products are stored strictly according to their labeled storage conditions. Food, beverages, and personal medicines are strictly prohibited within storage areas, maintaining a clean and compliant pharmaceutical environment.
Stock Control, Rotation, and Traceability
- FEFO Principle and Expiry Management
MVS Pharma applies the FEFO (First Expired, First Out) principle to ensure products with the earliest expiry dates are distributed first. Expiry dates are monitored regularly, and near-expiry products are identified, assessed, and managed in a controlled manner.
Batch traceability is maintained at the storage-location level, enabling full tracking of each batch throughout its storage lifecycle.
Security and Access Control
- Restricted Warehouse Access
Access to storage areas is restricted to authorized and trained personnel only. Security measures are in place to prevent unauthorized entry, product interference, or tampering, thereby safeguarding product integrity and supply chain security.
Housekeeping, Cleaning, and Pest Control
- Maintaining a Controlled Storage Environment
MVS Pharma maintains a documented cleaning program with defined schedules and responsibilities. Cleaning activities are recorded and reviewed regularly.
A pest control program is implemented through qualified service providers, and all related records are maintained under the Digital QMS. These measures ensure a hygienic environment that complies with EU GDP expectations.
Equipment Qualification and Maintenance
- Storage Infrastructure Reliability
Shelving, racks, and storage equipment are designed for pharmaceutical use and maintained to prevent damage to products. Environmental monitoring devices and critical equipment are calibrated annually, and preventive maintenance programs ensure reliable performance.
Conclusion
MVS Pharma GmbH is committed to maintaining a robust, secure, and GDP-compliant storage environment that consistently protects medicinal product quality. Through controlled environmental conditions, structured organization, continuous monitoring, and strong quality oversight, MVS ensures that products remain safe, stable, and fully compliant throughout their storage lifecycle.
