Seasonal Mapping, also known as thermal mapping of warehouse space is an important step in control of the supply chain for life science companies throughout the R&D, manufacturing, and distribution stages. Pre-production materials and finished bio-pharma products have specific storage conditions that must be measured, documented, and met to be compliant with current Good Manufacturing Practices. Deviations in these parameters can degrade products, potentially leading to ineffective or harmful medications. This is where temperature and humidity mapping studies become indispensable.
What is Seasonal Mapping?
Seasonal Mapping is a systematic study conducted to identify variations in temperature and relative humidity across a defined space, such as a warehouse, over a specific period. The EU Regulations recommend that a GMP warehouse mapping should run for at least 7 days to capture both static and dynamic conditions.
This study uses data loggers strategically placed throughout the storage area to capture environmental conditions under different scenarios, such as seasonal changes, operational workflows, and equipment performance.
Why is Mapping Essential?
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Regulatory Compliance
Pharmaceutical regulations, such as those outlined by Good Distribution Practices (GDP) and the EU GMP, require strict control and documentation of storage conditions for medicinal products. Temperature and humidity mapping is a foundational element of compliance, ensuring warehouses meet these guidelines and avoid regulatory risks.
MVS Pharma GmbH strictly adheres to EU GDP requirements by conducting comprehensive mapping studies for its storage facility. The company ensures that all monitoring devices are calibrated and that mapping results are documented and readily available for regulatory audits.
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Quality Assurance – Seasonal Mapping
Medicines can degrade when exposed to unsuitable environmental conditions. For example, excessive heat can denature proteins in biologics, while high humidity may lead to tablet dissolution or microbial growth. Mapping ensures that the storage environment consistently protects the integrity of these products.
At MVS Pharma GmbH, quality assurance is a top priority. The company’s quality management system includes regular mapping studies to identify potential risks and maintain product quality throughout the storage period.
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Risk Mitigation
Mapping studies help identify “hot spots” and “cold spots” or areas with excessive humidity, which may not be apparent without precise measurement. Once identified, targeted measures can be implemented, such as improving air circulation, adjusting HVAC systems, or relocating products to more stable zones.
MVS Pharma uses mapping results to mitigate risks proactively by optimizing warehouse layouts and promptly implementing necessary corrective actions. This ensures that even the most temperature-sensitive products are stored under ideal conditions.
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Audits and Validation
Temperature and humidity mapping provides documented evidence that a warehouse is suitable for pharmaceutical storage. This documentation is critical during inspections by regulatory authorities and when validating new storage facilities.
MVS Pharma GmbH maintains detailed records of all mapping studies and validation processes. These records are readily available for external inspections.
Conclusion Seasonal Mapping
Temperature and humidity mapping is not just a regulatory requirement but a proactive approach to ensure that products remain safe, effective, and compliant with regulatory standards. Our warehouse is equipped with state-of-the-art data loggers calibrated to ensure continuous monitoring 24/7/365. For MVS Pharma, this process represents more than compliance, it reflects the company’s dedication to set benchmarks in storage excellence, safeguarding both its products and its reputation in the industry.
Disclaimer:
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MVS Pharma GmbH will soon be launching an omega-3 dietary supplement onto the European market that has been developed for the highest quality standards in terms of oxidation avoidance and therefore greatest bioavailability. In addition, in vitro studies are currently underway at the University of Ulm, in which Professor Dr. Rüdiger Groß tested a patented mouth and nose spray (Virudol) that can eliminate various flu viruses based on natural substances. In addition, MVS has a wholesale license and has specialized in sourcing much-needed medicines such as Amoxicillin, Salbutamol, etc. from India through its local branch with a focus on local quality and safety testing, compliance with international GMP regulations and the highest quality level of user security (examples of local language brochures, identical units of measurement, batch control and full tracking, etc).
