Good practice guide noise mapping1/9/2023 ![]() ![]() Ovens, and custom built units, such as controlled room temperature environments, e.g., warehouses, walk-in cold rooms and freezers. Warm rooms designed to maintain consistent temperatures Purchased Commercial Off the Shelf (COTS) items (such as freezers, refrigerators, and incubators) ![]() Types of Controlled Temperature Chambers considered by this guide include: A Controlled Temperature Chamber is defined as a system, unit, equipment, or room in which the environmental conditions (usually temperature) of a chamber are controlled, maintained, and regulated to meet specific user requirements. Guidance is provided on Controlled Temperature Chambers used to store raw material, work in progress, or finished product, and which operate under current Good Manufacturing Practices (cGMPs). The approach described is consistent with that described in the ISPE Good Practice Guide: Cold Chain Management. The ISPE Good Practice Guide: Controlled Temperature Chamber Mapping and Monitoring provides industry good manufacturing practices for the temperature mapping of controlled temperature chambers, along with development of test acceptance criteria and a risk-based approach to practices for periodic review of system performance.
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