The factory building(s) for manufacture of drugs shall be situated in clean and hygienic surroundings. There shall be no open sewage, drain, public lavatory or dumping ground in the immediate vicinity. The premises shall be designed to minimize the risk of errors and permit effective cleaning and maintenance.

Buildings shall be designed and constructed to suit the manufacturing operations carried out in them. The layout and design shall aim to minimize the risk of cross-contamination and facilitate orderly flow of materials and personnel. Production areas, storage areas, quality control areas, and ancillary areas shall be appropriately designed and segregated.

Production areas shall be of adequate size for orderly and logical placement of equipment and materials. Working and in-process areas shall be adequate to prevent cross-contamination. Walls, floors and ceilings shall be smooth, free from cracks, and designed with coved junctions for easy cleaning. Surfaces shall not shed particles and shall permit easy and effective cleaning and disinfection.

Adequate ventilation shall be provided with air control facilities including filtration, temperature, humidity and pressure, as appropriate to the product being manufactured. Production areas shall have defined pressure differentials maintained between areas of different cleanliness levels. HEPA filters shall be installed for sterile manufacturing areas with integrity testing performed at regular intervals not exceeding six months.

Storage areas shall be of sufficient capacity to allow orderly storage of the various categories of materials and products with proper separation and segregation. Separate areas shall be designated for quarantined, approved, rejected, recalled and returned materials or products. Special attention shall be given to storage of highly active, radioactive, narcotics, other dangerous drugs, and substances presenting special risks of abuse, fire or explosion.