This category covers GMP requirements for facility design, including cleanroom classification, zoning, and flow concepts that support compliant operations and qualification.
Purpose and Scope Cleanroom design establishes the physical and environmental conditions needed to control contamination during regulated manufacturing. The design must support the intended process, protect the product where required, control exposure to personnel or the surrounding environment where applicable,…
Purpose and Scope Cleanroom classification provides a standardized method for determining the concentration of airborne particles in a cleanroom, clean zone, or separative device. Under ISO 14644-1, the classification result is expressed as an ISO Class, based on measured particle…
Purpose and Scope Material, personnel, product, equipment, and waste flows determine how people and items move through a GMP facility without creating unacceptable contamination, cross-contamination, or mix-up risks. Effective flow design considers more than separate arrows on a floor plan….
Purpose and Scope Facility zoning and segregation divide a GMP facility into areas with defined contamination risks, protection objectives, activities, access requirements, and environmental controls. Zoning establishes where each level of control applies. Segregation prevents incompatible products, materials, personnel, equipment,…
Purpose and Scope GMP facility compliance begins with binding regulatory requirements governing building design, space, flow, environmental control, sanitation, maintenance, and equipment placement. These requirements must then be translated into design criteria, qualification activities, operating procedures, monitoring, maintenance, and retained…