Contiguous campus

Single facility Common Personnel No other changes Same contiguous campus... 

Level 2 changes consist of site changes within a contiguous campus, or between facilities in adjacent city blocks, where the same equipment, SOP s, environmen-tal conditions (e.g., temperature and humidity) and controls, and personnel common to both manufacturing sites are used, and where no changes are made to the manufacturing batch records, except for administrative information and the location of the facility. 

Contiguous Campus Continuous or unbroken site or a set of buildings in adjacent city blocks. 

Single facility -Common personnel -No other changes -Same contiguous campus -Common personnel -No other changes... 

Site changes within a contiguous campus, or between facilities in adjacent city blocks, where same equipment,... 

Contiguous Campus—Contiguous or unbroken site or a set of buildings in adjacent city blocks Creams/Lotions—Semisolid emulsions that contain fully dissolved or suspended drug substances for external application. Lotions are generally of lower viscosity Diluent—Vehicle in a pharmaceutical formulation commonly used for making up volume or weight (e.g., water, paraffin base)... 

Level 2 Contiguous campus No scale or process changes None compendial only Application/ None CBE ... 

Different campus—one that is not on the same original contiguous site or where the facilities are not on adjacent city blocks. 

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