Guidelines for Area Classification and Air Handling

To provide the guideline for classification of areas to prevent mix-ups and cross-contaminatio 

It is the responsibility of all departmental managers to follow the procedure. The quality assurance manager is responsible for SOP compliance. 

The different areas within a pharmaceutical plant must be identified. According to the classification, the following requirements should be fulfilled  

Nonmanufacturing areas, such as warehouse, administration, and workshop facilities, comprise the black area. Control of the warehouse storage conditions (temperature and relative humidity) is recommended, where 

These are areas where primary packaged products are handled (e.g. visual inspection of ampules, vials, blisters, and final packaging operations). Depending on the product mix manufactured, the control of temperature and relative humidity may be necessary. 

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