A critical review of the validation process for insulated containers containing temperature-sensitive pharmaceuticals, and the need for standardisation

Abstract

All pharmaceutical products are required to be stored and transported between specific temperature ranges. In certain cases, these products need to be stored and transported between 2-8°C. This requirement is set out by the manufacturer at the time of developing the product. This is to ensure that it does not degrade to a level below acceptable quality standards, and that it maintains stability over its usable life, as defined by the manufacturer and approved by the regulatory authorities. In order to confirm that the product is not exposed to temperatures outside of the required range, systems and equipment, with specific reference to insulated containers used to store and transport pharmaceuticals, must be validated. One of the main obstacles to robust and reliable validation is variability. The aim of this paper is not to define a standard, but rather to expand knowledge and increase awareness in the industry with regard to available validation techniques. This would be the first step towards a standard methodology, developed by the industry and key stakeholders, that may serve as a benchmark as to how validation should be conducted. The intent of this paper is to raise awareness in this regard, and suggest which aspects could perhaps be standardised, as well as outline a potential departure point for these standards.