Cold Chain Logistics

Design, Validation, Implementation & Monitoring

In a United Parcel Service (UPS) 2009 survey of large and small healthcare manufacturing companies, UPS found that regulatory challenges were the top supply-chain concern for both large and smaller healthcare companies. The majority of large companies (74%) cite temperature-sensitive concerns as the top regulatory challenge from a supply chain standpoint. Modality Solutions understands and plans from day one for the importance of meeting each client’s unique cold chain challenges. Our team has extensive experience in cold chain design, validation, implementation, and monitoring.

Cold Chain Controlled-Environment Logistics

Environmentally-controlled logistics for supply chains are rapidly evolving. Increasing regulatory scrutiny on global supply chain process controls means more product and process data will be needed to show that the stress introduced during transport does not impact product quality or reduce shelf life.

Our clients’ needs are driven by key global forces:

  • More environmentally-sensitive products in development.
  • Greater volume of biologics in the market (per capita and volume).
  • Higher risk of economic loss per package.
  • Global manufacturing and distribution.
  • Complex supply chains.
  • Better technology for packaging design, controls, and monitoring.
Based on the convergence of these fast-paced changes, Modality Solutions is ideally positioned to serve as thought leader experts. With our extensive industry knowledge, our team brings a wealth of experience to our clients in the following critical areas:
  • Environmental characterization and analysis.
  • Packaging design and qualification.
  • Packaging and product testing in extreme "worst case” environments.
  • Risk-based process validation approach.
  • Process monitoring and Six Sigma methodology.

A Maze of Regulatory Guidances

Let us help you make it from start to finish through the maze of regulations and compliance cold chain management. Both government and industry have established practical guidances for qualifying cold chain temperature-controlled transportation processes, sensors, and packaging in much the same way manufacturing processes are regulated with cGMP. Quality systems are expanding from the manufacturing-centric approach into both the clinical and commercial supply chain. Standalone GDPs, typically a subset of GMP guidance, are new. Over 35 countries have published specific GDP guidances. Although the initial focus in these guidances was on cold chain, regulators have expanded their reach to GS1 serialization standards, anti-counterfeit and diversion concerns, licensed trade partners, quality agreements and data sharing. This increased global focus from regulators has made controlled-environment logistics a standard audit item during any inspection.

Our multi-disciplinary team is ready to help you with your cold chain needs or existing program. For more information, contact us today.