Guidance for Buildings and Facilities
Buildings and Facilities involved in the of drug products must be designed and constructed appropriately, incorporating provisions that help prevent contamination.
In the pharmaceutical industry, it is essential for organizations involved in the manufacturing, processing, packing, or holding of drug products to adhere to Good Manufacturing Practice (GMP). GMP is defined under 21 CFR 210 and 211. Part 211 offers extensive guidelines for finished pharmaceuticals and provides requirements for personnel, buildings, and facilities, equipment, components, drug product containers, process, laboratory, packaging, and labeling controls.
Considering that pharmaceuticals have a significant impact on human health, special care must be taken, such as designing with adequate flow of materials and personnel to prevent contamination during the manufacturing process. Buildings and facilities involved in these manufacturing processes must always be designed and constructed appropriately to ensure that drug products are safe for human consumption.
Subpart C of 21 CFR Part 211 specifies guidelines for Buildings and Facilities involved in the manufacturing, processing, packing, and/or holding of drug products. These buildings are expected to be of suitable size and construction to facilitate proper operations, enable cleaning and maintenance. Such facilities are required to have sufficient space in which to appropriately place equipment and materials. This measure is essential to prevent contamination or mix-ups between different components, drug product containers, closures, labeling, in-process materials, or drug products. Also, appropriately sized areas must be provided for the facility’s operations. These separate areas will help prevent contamination during the manufacturing and storage of components, drug product containers, closures, and labeling material that is awaiting inspection by the quality control unit before release for production or packaging.
Subpart C also specifies various essential provisions that must be present in these buildings. For example, adequate lighting must be provided in all areas of the facility. There must also be an appropriate number of washing and clean toilet facilities that are easily accessible to working areas. These washing facilities must provide hot and cold water, soap, and air driers or single-use towels. Adequate ventilation must also be provided, including equipment for air pressure control, microorganisms, dust, humidity, and temperature. Air filtration systems should be used to supply air to production areas. In the case that air is recirculated to production areas, the recirculation of dust must be controlled by the use of HEPA filters, usually tested for efficiency at the filter manufacturing site using a thermally produced aerosol. Similarly, adequate exhaust systems must be provided to control contaminants in areas where contamination could occur during production.
Plumbing requirements must also be followed, including supplying potable water under continuous positive pressure in a defect-free plumbing system. All drains at a manufacturing facility must be appropriately sized, and the drains that are connected to a sewer should be provided with an air-break to prevent back-flow. Lastly, provisions must be made to ensure that sewage and trash are disposed of in a safe and sanitary manner.
Adhering to such measures ensures that facilities are fit to manufacture, process, pack, and/or hold drug products without contamination.