BUILDING AND FACILITY

GENERAL REQUIREMENTS

Layout and design of premises 

prevent/minimize

• The risk of error
• Cross Contamination
• Dust Buildup

Location of Premises

Location should be in an environment that protects the processes, materials and the product from contamination.

Requirements

• smooth easy to Clean surfaces
• Sufficient light
• HVAC facility to control temperature, humidity and ventilation.
• HVAC design and qualifications for sterile/nonsterile manufacturing, AIr Changes, Air Flow Patterns, Differential Air Pressures etc.
• Insects and pest control
• Dedicated and logical flow of materials and personnel

dedicated areas

• Facility must offer dedicated areas for
• Quarantine areas for incoming materials
• Rejected Materials and rejected finished goods areas under lock and key
• Storage of released components, drug product containers, closures, and labeling;
• Storage of in-process materials;
• Manufacturing and processing operations;
• Packaging and labeling operations;
• Quarantine storage before release of drug products;
• Storage of drug products after release;
• Control and laboratory operations;
• (Aseptic processing, which includes as appropriate

ANCILLARY AREAS

• • Separate rest and refreshment rooms
  • Easy access to facility for changing and storage of clothes and toilets
  • Maintenance workshop separated from production areas