Buildings and Facilities Office

Building and Facilities Control Room

People in this department are concerned with the plant's external and internal environment: how buildings are constructed, the environment around the buildings, pest control, sewage, air conditioning, water systems, and the like. Facilities, building services, and utilities not only need to be operating correctly, but maintenance schedules and records must be kept for GMP reasons.

Example of a GMP expectation that applies to Buildings and Facilities

The facility is designed, constructed, and maintained to prevent mix-ups and contamination of the drug product, and cross-contamination between drug products.

Example of GMP requirements specific to this GMP expectation

  U.S.

• Any building used in the manufacture, processing, packing, or holding of a drug product shall be of a suitable size, construction and location to facilitate cleaning, maintenance and proper operation. [211.42(a)]

• 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...[211.42(c)]

• Any building used in the manufacture ...of a drug product shall be maintained in a good state of repair. [211.58]

• Prevention of mix-ups and cross-contamination by physical or spatial separation from operations on other drug products. [211.130(a)]

  Canada

• The premises are designed, constructed and maintained such that they prevent the entry of insects and other animals into the building and also prevent the migration of extraneous material from the outside into the building and from one area to another. [C.02.004 #2]

• Rest, change, wash-up, and toilet facilities are well separated from production areas and are sufficiently spacious, well ventilated, and of a type that permits good sanitary practices. [C.02.004 #5]

• Premises layout is designed to avoid mix-ups and generally optimize the flow of personnel and materials. [C.02.004 #6]

  European Union

• Premises should be situated in an environment which, when considered together with measures to protect the manufacture, presents minimal risk of causing contamination of materials or products. [EU #3.1]

• Premises should be carefully maintained, ensuring that repair and maintenance operations do not present any hazard to the quality of products. They should be cleaned and, where applicable, disinfected according to detailed written procedures. [EU #3.2]