Managing Cold Chain Distribution Across the Global Supply Chain: Trends and Regulations
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 a 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.
Source: Pharmaceutical Outsourcing