ISPE Good Practice Guide: Controlled Temperature Chamber Mapping and MonitoringThere is an increased regulatory interest in cold chain driven by the growing number of products requiring controlled temperature shipping and storage, the complexity of the distribution network for the products, and governmental requirements for distribution of vaccines.

The ISPE Good Practice Guide: Controlled Temperature Chamber Mapping and Monitoring provides guidance on the definition of the requirements (producing a user requirements document), design, purchasing, commissioning (including temperature mapping), qualification, and maintenance of controlled temperature chambers operating under current Good Manufacturing Practices (cGMPs).

Types of controlled temperature chambers considered by this guide range from purchased commercial off the shelf items, such as freezers and incubators, walk-in cold rooms and walk-in freezers, to custom built units, such as warehouses.

This guide provides a number of benefits in an area where there is little authoritative guidance, including:

  • Provision of industry good practice for the temperature mapping of controlled temperature chambers, considering the impact of load, and the use of the data to determine the location and number of monitoring sensors
  • Development of test acceptance criteria
  • A risk-based approach to practices for periodic review of system performance

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