WHO Technical Report Series, No. 961, 2011 Document below...
Document attached to this post is the technical supplement 7: Qualification of temperature-controlled storage areas. Experts on the specification for Pharmaceutical Preparations provide guidance to qualify new temperature-controlled storage areas and new refrigeration equipment before it becomes operational.
This supplement was written to amplify recommendations given in section 4.7 of WHO Technical Report Series No. 961, 2011. This supplement focuses on the three (3) stages of qualification needed before release of a temperature-controlled area for routine use.
- Stage one: Installation Qualification (IQ) Demonstrates that the process or equipment meets all specifications, is installed correctly, and all required components and documentation needed for continued operation are installed and in place.
- Stage two: Operational Qualification (OQ) Demonstrates that all facets of the process or equipment performs as specified, when operated in accordance with Standard Operating Procedures and manufacturer’s recommendations; and confirms that the equipment is capable of meeting its intended use.
- Stage three: Performance Qualification (PQ) Demonstrates that the process or equipment consistently performs as intended under routine operating conditions. Qualification activities should be planned and documented. This guide walks you through each stage and provides examples and tables for checks and testing.