SUPPLY CHAIN
Managing Cold Chain Distribution Across the Global Supply Chain: Trends and Regulations
Bikash Chatterjee
President and Chief Science Officer, Pharmatech Associates
Supply chains now span the globe and are increasing in complexity as organizations move away from regional business models to manufacturing and distribution on a world scale. A critical byproduct of good manufacturing practice (GMP), an unbroken cold chain ensures product safety, efficacy and overall quality for patients. The need for regulations, industry standards and service providers that can support the cold chain process has grown as fast as the asset value of biologics and new drug delivery systems has increased. While it would be ideal to have one reference standard and best-practices approach, there is no magic bullet. It is important to understand what regulations and industry practice standards do exist in order to craft a practical, manageable approach to a secure and consistent cold chain.
Cold Chain Management
Cold chain management and logistics is a specialized concentration within supply chain management that utilizes temperature controlled transportation and storage and distribution systems to ensure the product remains within its recommended conditions. A cold chain management program is meant to:
• Ensure the appropriate storage and handling conditions (temperature) are maintained throughout the cold chain.
• Document the storage conditions (temperature) throughout the cold chain.
• Maintain the product safety and integrity throughout the cold chain (temperature, counterfeiting).
The basic elements of a pharmaceutical or biologic cold chain are shown in Figure 1.
Establishing an effective cold chain strategy requires the thoughtful integration of cold chain requirements starting with product design and extending to environmental control during transit. Integrating Quality Risk Management (QRM) principles at strategic points within product development is the best way to anticipate downstream cold chain challenges.
Best-in-class organizations undertake primary packaging studies as the first step in answering the larger product stability and environmental label claim requirements. Framing this activity as an integral part of the cold chain design activity rather than perceiving it as a strictly product development activity allows commercial considerations to be
Pharmaceutical Outsourcing | 22 | July/August 2016 Figure 1.
included in the product design discussion. This holistic view provides the greatest opportunity for defining any subsequent commercial cold chain alternatives, such as shipper design, active vs. passive container design decisions, and country-specific regulatory requirements. The key elements of some of the major activities that can influence an effective governance strategy are shown in Figure 2.
Regulatory Considerations
The drug sponsor takes primary responsibility for ensuring that the product is fit for use. Specifically, manufacturers of cold chain products have direct control over the correct storage and handling of their
Figure 2.
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