Qualification of temperature-controlled storage .

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Qualification of temperature-controlled storage areas ( summary and questions

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. Introduction This Technical Supplement has been written to amplify the recommendations given in section 4.7 of WHO Technical Report Series No. 961, 2011, Annex 9: Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products. 4 It covers the three stages of qualification needed before the release of a temperature-controlled storage area for routine use: installation qualification (IQ), operational qualification (OQ) and performance qualif...

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Qualification of temperature-controlled storage . • Qualification of temperature-controlled storage .