Quality Cold-Chain Management Systems
Valcomm offers temperature sensitive supply chain and Good Distribution Practice (GDP) consultancy and qualification services with a focus on achieving GDP cold chain compliance for the pharmaceutical and life science industries.
Our consultants combine extensive global business experience in GDP cold chain validation and technical expertise to provide invaluable cold chain knowledge.
Temperature supply chain design
GDP supply chain compliance
Eliminating temperature excursions
Selecting the correct packaging/monitoring solution
Prepare protocols and templates
Matching validation to your supply chain
Supply chain validation process
Reducing risks and associated costs
Gaining efficiency in temperature supply chain
Global regulations and compliance
Cold chain refers to the undisrupted series of logistical activities including packaging, shipping, storage, distribution and handling of products that must be maintained within a given temperature range for its whole shipment process.
As a result of cold chain goods needing constant low temperatures, maintaining cold chain processes effectively is critical to the integrity of therapeutic products.
In the United States, the Centre for Disease Control and Prevention (CDC) has estimated that $300m (£190m, €240m) worth of vaccines alone are destroyed each year due to improper storage and distribution. The numbers for other therapeutics are unknown. The scary aspect of that figure is that this includes only the product that was known or suspected to be compromised.
The health care implications for administering compromised medications to patients go well beyond economic losses and can, in extreme cases, result in catastrophic consequences.
Patient safety and regulatory compliance are the key drivers within cold chain logistical systems. Organisations recognise the growing need for control of the entire cold chain and the ever changing global scenario requires highly efficient processes as a backbone to accommodate the growing needs of organisations.
Due diligence in cold chain means not simply using a qualified shipper, but qualifying the shipper to perform within the entire shipping process, whether overnight, or extended periods of time to another region.
Commissioning a transit study to qualify your shipping system will lower costs including dramatically reducing loss of material and the repetitive testing of suspect material.
A transit study will allow you to identify when a more expensive shipper combined with a less expensive transport option is more cost effective than a less expensive shipper, combined with occasional use of a specialised courier service.
Warehouse & Refrigeration Mapping & Qualification
Valcomm undertakes thermal mapping studies of both small and large-scale cold room, freezer room, warehousing facilities and transport vehicles to determine the conformance to temperature requirements.
Thermal mapping is effectively a heat distribution study, investigating conformity of temperatures throughout the storage areas.
A temperature mapping study is essential to identify locations and positions for monitoring equipment. Valcomm prepares documentation procedure and conducts temperature mapping to meet all regulatory and GDP requirements.
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