Any building or buildings used in the manufacture, processing, packing, or holding of a drug product shall be of suitable size, construction and location to facilitate cleaning, maintenance, and proper operations.
Any such building shall have adequate space for the orderly placement of equipment and materials to prevent mix ups between different components, drug product containers, closures, labeling, in-process materials, or drug products, and to prevent contamination.
The flow of components, drug product containers, closures, labeling, in-process materials, and drug products through the building or buildings shall be designed to prevent contamination.
Operations shall be performed within specifically defined areas of adequate size.
There shall be separate or defined areas for the firm's operations to prevent contamination or mix ups.
An air supply filtered through high-efficiency particulate air filters under positive pressure, regardless of whether flow is laminar or non-laminar.
Adequate lighting and ventilation shall be provided in all areas.
Air filtration systems, including pre-filters and particulate matter air filters, shall be used when appropriate on air supplies to production areas.
If air is recirculated to production areas, measures shall be taken to control recirculation of dust from production.
In areas where air contamination occurs during production, there shall be adequate exhaust systems or other systems adequate to control contaminants.
Potable water shall be supplied under continuous positive pressure in a plumbing system free of defects that could contribute contamination to any drug product.
Potable water shall meet the standards prescribed in the Environmental Protection Agency's Primary Drinking Water Regulations.
Water not meeting such standards shall not be permitted in the potable water system.
Drains shall be of adequate size and, where connected directly to a sewer, shall be provided with an air break or other mechanical device to prevent back-siphon age.