What is GMP?
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. A good factory design ensures that the facility designed follows GMP or cGMP standards. Furthermore, an industrial architect has to use his experience and knowledge to design a factory.
Additionally, cGMP or current Good Manufacturing Practice is the latest set of regulations for maintaining a proper design, monitoring and control of processes and factories.
Role of factory design in a GMP Facility
The industrial architect has to design the facility as per the cGMP regulations. Some of the features that can be incorporated while preparing the factory design are:
- The design and construction should be so that the production is under hygienic conditions.
- There should be no way for the entry of insects, pests, birds, vermins, and rodents.
- The facility should have a laboratory.
- The factory should be spacious.
- The facility has to be at a location where there are no fumes. The design should be able to prevent any fumes or infestation of the product.
- There should be coving on walls and floors, and surfaces should have cleanable surfaces. Furthermore, the manufacturing area should be free of cracks and open joints to avoid the collection of dust.
- There should be segregation between personnel and man-entry.
- The industrial infrastructure design should have a dedicated HVAC system based on area classification.
- There should be a step down between rooms
- The facility should have a flexible layout.
- Additionally, the design has to provide for well lit, ventilated production areas with air control facilities.
- The industrial architect should design the drainage system to prevent backflow and size adequately.
- Avoid open drains.
- The construction process should not cause any negative impact on the environment.
- The facility should have a provision for hazardous waste, inflammable materials as per the regulations.
- A proper fire protection system has to be designed.
- Piping, electrical fittings and other utilities should not create a recess.
- Colouring and direction of flow on services lines should be provided
- And finally, the disposal of industrial wastes has to be disposed of as per the Pollution Control Board.
Cleanroom and factory design
The factory design consultant has to consider many factors while designing the cleanroom. The cleanroom in the facility design should comply with GMP standards. Also, the filtration, wall construction, lights, temperature, humidity etc., should maintain the GMP standards.
Warehouse Design for GMP compliance
Factory design for a GMP compliant warehouse includes having designated areas for raw materials, finished goods, quarantine products, rejected products etc. The warehouse must be dry, clean and well lit. The storage conditions shall be as per the material requirements
To conclude, Good Manufacturing Practice includes designing the facility to be compliant with the CGMP standards. Consequently, the role of an industrial architect becomes essential for any cGMP compliant facility.
