Factory Design in a GMP-Compliant Factory

What does GMP mean?

Good Manufacturing Practices or GMP is a system to ensure that the product follows fixed standards and regulations, especially in the healthcare, pharmaceutical, and food industries. Industrial architects prepare a factory design that follows GMP or cGMP standards.

For GMP compliance, the industrial architect has to be update with the GMP requirements. Additionally, cGMP or current Good Manufacturing Practice are a set of regulations for maintaining a proper design, monitoring, and control of processes and factories. 

Importance of Factory Design in a GMP-Compliant Facility

The GMP-compliant facility needs to follow the GMP standards for design. Some of the standards are :

• The design and construction must ensure a hygienic production.
• The facility should not have an opening for the entry of insects, pests, birds, vermins, and rodents.
• The laboratory is an essential part of a GMP-compliant facility.
• The factory must be spacious.
• The location of the facility must be selected so that no fumes or infestation of the product is possible. 
• Coving on walls and floors is an essential feature of GMP facilities. 
• Surfaces should be easy to clean.
• The manufacturing area should be crack-free. 
• There should not be the possibility of dust collection. 
• There should be seperate personnel and man-entry.
• A dedicated HVAC system based on area classification is a must.
• Flexible layout for the facility. 
• A well-let facility with proper ventilation and air control is essential.
• The drainage system should have provisions to prevent backflow and size adequately.
• No open drains. 
• The construction process should have minimal or no negative impact on the environment. 
• Provision for hazardous waste and flammable materials as per the regulations is a must.
• There must be a proper fire protection system.
• Piping, electrical fittings, and other utilities should not create a recess.
• The piping and services lines should have coloring and direction of flow.
• And finally, the disposal of industrial wastes must be as per the Pollution Control Board.

Cleanroom and factory design

The cleanroom which often is a part of a GMP-compliant factory must have the filtration, wall construction, lights, temperature, humidity, etc., as per GMP standards.

Warehouse Design for GMP compliance

There must be designated areas for raw materials, finished goods, quarantine products, and rejections. The warehouse must be well-lit, ventilated, and dry. 

Finally, though Good Manufacturing Practices are majorly for the product, the facility design also must comply with the CGMP standards. Consequently, the role of an industrial architect is critical for any cGMP-compliant facility.