Design Qualification Guideline for HVAC System of a Pharmaceutical Plant

Design Qualification Guideline for HVAC System of a Pharmaceutical Plant 

To provide the qualification design guide line for the HVAC design of pharmaceutical manufacturing plant 

The HVAC assigned to the project should use the following guidelines to control the quality of the design from a cGMP perspective. The checklist that follows should be completed and used to control the quality of working drawings, revisions, and related documents. 

As a predecessor to detailed design, the HVAC should meet with your company s basic project management. Parameters should be designed for the facility on an area-by-area basis. Meeting results should be documented and form the basis for design criteria. The approval of these criteria must be obtained prior to proceeding with design. 

The purpose of the design criteria is to establish a basis for facility HVAC design and to provide your company with a document for FDA facility review. 

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