PERFORMANCE QUALIFICATION PROTOCOL COM REPORT OF COLD STORAGE ROOM

PharmaGuide Hub

May 30, 2026

The objective of the performance qualification is to demonstrate that the process as operated under

Normal expected conditions will produce acceptable output. Performance Qualifications are a collection

of test cases used to verify that a system performs as expected under simulated real-world conditions.

The PQ should be conducted annually under normal usage. The temperature for the cold room or chamber is the

critical parameter, since excursions in temperature conditions may affect the quality of

stored material(s). It is essential, therefore, to qualify cold room performance under a worst-case scenario.

The approach described above for conducting the performance qualification of such cold rooms or chambers, with the consideration of all possible challenges that may have a bearing on the desired acceptance criteria, addresses each potential issue.

Conducting the studies following the methodology outlined, the impact of situations such as opening the door or power failure for a given period can be known.

Further, through these procedures, it is possible to identify the hot spot and cold spot and the time required to regain the desired temperature conditions if disturbed because of adverse conditions.

Qualification is commonly used to validate pharmaceutical manufacturing processes, but it can also be applied to the pharmaceutical supply chain in general and to temperature-controlled storage processes and equipment in particular.

In this later context, temperature-controlled storage covers any area where TTSPPs have to be stored within a controlled temperature range (e.g., 2-8°C, 15-25°C). This includes active temperature-controlled storage equipment, including ultra-low freezers, refrigerators, cold rooms, and controlled-ambient stores.

Actively temperature-controlled transport equipment. This includes refrigerated and temperature-controlled trucks and vans and refrigerated and temperature-controlled ocean containers. Refer to the companion technical supplement.

Qualification of temperature-controlled road vehicles. Passive temperature-controlled packaging systems (shipping containers). This includes insulated containers used to maintain product temperature during road and air transport.

Reason: To avoid the risks associated with overstocking and to ensure that good warehousing practices can be adopted (i.e., first-in, first-out (FIFO) or earliest expiry-first out (EEFO). Overstocking makes FIFO or EEFO handling difficult or impossible and hinders accurate physical stock counts.

Storage capacity of temperature-controlled stores: Ensure that the net storage capacity of the temperature-controlled stores is sufficient to accommodate peak TTSPP stock levels and their associated transit temperature protection components (i.e., freezer blocks, flexible ice blankets, refrigerated gel packs, phase change materials, and insulated packaging, if retained), under correct temperature conditions and in a manner which enables efficient and correct stock management operations to take place.

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