GMP facility

The designated location of buildings and facilities must be appropriate to the processes performed and products handled.

The design must permit all necessary cleaning, maintenance and proper access to the process.

The design of the building and facility must conform to all Health & Safety internal and external requirements.

Design documents as a basis for design qualification of the facility (e.g. layout, environmental zoning concepts, room data sheets, etc.) must be provided and kept updated.

The design must ensure adequate lighting for the work being performed.

When required, environmental controls such as temperature and humidity of the production, testing and storage areas must be designed and maintained to ensure the quality of the products and/or materials as well as to ensure the reliability of the equipment.

There must be appropriate protection against the entry of pests.

The access to production areas must be limited to those working in these areas. There must be measures to prevent unauthorised access.

The number of drains must be limited. Where necessary they must be designed appropriately to the environmental zones where they are located.

The design must ensure the prevention of mix-up and cross-contamination by means of space, segregation, ventilation and logical workflow for materials and personnel.

Services (pipes, lights, etc.) must be designed to facilitate appropriate cleaning and maintenance.

Facility surfaces must be smooth, non-particulate shedding, free from cracks, and open joints in all areas where the quality of the products could be compromised and must not present risks of either microbiological or particulate contamination.

Facilities must be of a design suitable for their intended purpose. If Highly potent medicines are produced, additional protection measures are required.

Areas with restricted personnel access must be designed with features that facilitate the supervision of employees working within those areas.

Each facility must have appropriate waste disposal systems.

Special provisions, such as localised exhaust systems, must be used in areas where dust or fumes are generated.

Special provisions must be made for production, testing and storage of materials and products with special Health & Safety requirements (e.g. penicillins, cephalosporins, hormones, Highly Active Pharmaceuticals, and biologicals).

Equipment washing facilities must be suitably designed to ensure that the equipment can be cleaned, handled and stored in a manner that is appropriate for its use.

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