Transcription of Annex 5 Supplementary guidelines on good manufacturing ...
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215 World Health OrganizationWHO Technical Report Series, No. 961, 2011 Annex 5 Supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms1. Introduction2. Scope of document3. Glossary4. Products and personnel Air fi ltration Unidirectional airfl ow Infi ltration Cross-contamination Displacement concept (low pressure differential, high airfl ow) Pressure differential concept (high pressure differential, low airfl ow) Physical barrier concept Temperature and relative humidity5.
216 1. Introduction Heating, ventilation and air-conditioning (HVAC) play an important role in ensuring the manufacture of qual ity pharmaceut ical products .
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