Global Pharmaceutical Supply Chain

ABSTRACT: Cold chain products are the products which requires special temperature controlled storage.Cold chain storage system is used to store vaccines, certain injectable preparations. Maintaining the temperture is necessary not only during the manufacturing but the product has to be stored up to the destination (patient). Cold chains are common in the pharmaceutical and food industries.One common temperature range for a cold chain in pharmaceutical industries is 2 to 8 °C but the specific temperature (and time at temperature) tolerances depend on the actual product being shipped. Cold chains are essential for storage and distribution of goods and temperature sensitive pharmaceuticals & biological preparations & forms an integral part of their supply chain. There is global regulatory requirement for handling, storing and distributing environmentally sensitive products i.e. cold chain products. Traditionally all historical stability data developed for vaccines were based on the temperature range of 2-8 °C. With recent development of biological products by former vaccine developers, biologics has fallen into the same category of storage at 2-8 °C due to the nature of the products and the lack of testing these products at wider storage conditions. The standardised use of qualification, validation and good cold chain management practice will be benificial for all involved parties in handling; storing and distributing environmentally sensitive pharmaceuticals.This article reviews the increased importance of validation of pharmaceutical cold chain products and its regulatory requirement. Key Words: validation, cold chain, qualification The expiration date and assurance of potency of vaccine