An equipment validation protocol for evaluating procedures for monitoring, maintaining, cleaning and operating a built-in, walk-in refrigerator for storing GxP raw materials and finished products at a temperature range of 2 to 8 degrees C. Also includes functional verification of system components, including controls and alarms, and temperature mapping using a Kaye thermal validator. Includes the following data collection forms, OQ Prerequisites, SOP Review, Functional Tests, Empty Cold Room Temperature Mapping Study, Dynamic Temperature Mapping Prerequisites, and Dynamic Temperature Mapping Study. For other documents in this validation package, see 11-0042-IQP-1.0, 11-0042-IQR-1.0, and 11-0042-OQR-1.0.
| Edition : | 1.0 |
| File Size : | 1
file
, 160 KB |
| Number of Pages : | 14 |
| Published : | 08/01/2004 |
