| Temperature mapping | a documented study of temperature distribution within storage areas, including identification of the cold, hot and critical spots (EEC Guideline). |
| Hot spot | the maximum temperature values recorded during mapping that are within the acceptable range. |
| Cold spot | the minimum temperature values recorded during mapping within the acceptable range. |
| Critical spot | the location with the most significant temperature fluctuations. |
| Temperature fluctuations | changes and variations in storage temperature. |
| Temperature excursion | measured values falling outside the established storage range, posing a risk to quality. |
| Zone | a room or part of it, a cold room or freezer room used for receiving, dispatch, quarantine and storage of medicinal products. |
| Temperature-controlled environment | an environment whose temperature is maintained actively or passively within a predefined range. |
| Electronic data logger | a measuring instrument that records temperature over a set period, stores the data and transmits it electronically. |
| Sensor | a structurally separate device with one or more primary measuring transducers. |
| Acceptance criteria | predefined requirements that a storage area must meet based on the study results. |
| Qualification | documented evidence that premises and equipment are correctly installed, operate properly and produce the expected results. |
| IQ, OQ, PQ | installation, operational and performance qualification. |
| URS | user requirements specification, the source document for qualification criteria. |
| Cold chain | a system of measures and equipment that maintains the required temperature conditions for vaccines and other temperature-sensitive products from manufacturer to end user. |
| Temperature indicator | a device that irreversibly records a temperature threshold being exceeded or the cumulative heat exposure. |
| Temperature-sensitive medicinal product | a product that requires special temperature storage conditions, most often +2…+8 °C. |
| Immunobiological medicinal products | vaccines, toxoids, immunoglobulins, sera, etc. |
| Verification | a set of operations confirming that a measuring instrument meets metrological requirements; results are entered in FSIS Arshin. |
| Calibration | determination of the actual values of a measuring instrument’s metrological characteristics. |
| CAPA | corrective and preventive actions. |
| Low-voltage systems | fire alarm system, fire warning and evacuation system, access control system (ACS), CCTV (video surveillance), structured cabling system (SCS). |
| GAMP 5 | ISPE guidance on a risk-based approach to computerized system validation. |
| ALCOA+ | data integrity principles: attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, available. |
| Hold time | the time during which equipment or an insulated container maintains the required conditions without power or coolant. |