PDA TR 64-2013

Active Temperature-Controlled Systems: Qualification Guidance

Fundamental to any temperature-controlled process is the expectation that materials that are stored and shipped within a controlled environment are maintained within a defined temperature range. Typically, this temperature range is within the recommended product storage requirements derived from stability data. The temperature within a temperature-controlled vehicle; temperature-controlled ocean container; active unit load device (ULD); or walk-in, temperature-controlled stores (e.g., a cold room, refrigerator, freezer, or standalone unit) is expected to be maintained: Reliably and consistently through the period in which the product is stored within the controlled environment (i.e., over time); In compliance with the product requirements for temperature at all locations in which the product might be stored (i.e., temperature and location or storage boundary)

Parenteral Drug Association [pda]

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