Pharmaceutical Plant

For setting up a pharmaceutical plant, it is necessary to make a plan and a plant layout once the location of the plant is fixed. A pharmaceutical plant layout involves the proper allocation of space and arrangement of different machines and other important services needed in the production of pharmaceuticals. 

Good manufacturing practices (GMP plant) layout has been laid down as a guideline for the construction of pharmaceutical plants. The main aim of these guidelines is to ensure that medicines and health products manufactured are safe and effective. Different types of pharmaceutical plant layouts have been set up according to the guidelines. 

Pharmaceutical Plant Layout

Proper layout is essential before setting up a pharmaceutical plant. It is a continuous process that involves making changes and adjustments throughout the process. The National Agency for Food and Drug Administration (NAFDAC) has set some general guidelines as to what the pharmaceutical plant layout should focus on. It should aim to prevent all sorts of adverse effects on the products manufactured, including product contamination due to dust or dirt.

Types of Pharmaceutical Plant Layout

Organizations can decide and select the types of pharmaceutical plant layout needed for their plant based on the types, nature and size of products to be manufactured in the plant. 

There are mainly five different types of pharmaceutical plant layouts:

1. Product layout: The emphasis on product layout is manufacturing quality products in quantity. All the machines for production are lined up in the required order for manufacturing, popularly known as line layout. The workload is balanced for each machine for balancing the line, which helps eliminate any bottleneck situations. It maximizes labour and machine utilization and helps in quality control. Duplication of machines for different products is the main disadvantage of this layout, which requires more space. 
2. Process Layout: In process layout or functional layout, all the machines for similar operations are grouped in one location. Here, several products may share the same machine for different processes in product development. The process is given more importance. The major advantage of this type of layout is that it avoids machine duplication and flexibility if production increases, thereby supporting optimum use. The main disadvantage of this layout is its complexity in connecting the different machines for different products.
3. Combined Layout: A combined layout is the combination of product and process layouts. It has the benefits of both layouts. A combined layout is a widely used plant layout. Pure product or process layouts are not practically efficient. 
4. Project Layout: In product and process layouts, machines are fixed in particular positions, and the products are moved for completing the manufacturing process. However, in cases where the product size is huge, it is impossible to move the product multiple times. In such situations, the project layout is used, where the product remains stationary while the machines and labourers move around to complete process development. 
5. Group Layout: This layout is an intermediate between process and product (line) layout. It has the advantages of line layout and is used in cases where pure line layout is not practical. 

GMP Plant Layout

GMP stands for Good Manufacturing Practices. These are some of the guidelines considered in granting a licence to a manufacturing plant. GMP is a method of quality assurance to ensure that the products are appropriate for manufacturing purposes. 

GMP is a system comprising all the procedures and documentation to make sure that the products are produced per the quality standards. These practices help in minimizing the risk factors of the product. A GMP plant layout addresses quality management, pieces of equipment, personnel, raw materials, buildings, sanitation and many more areas. The 5 P’s of GMP include People, Products, Processes, Procedures and Premises. All these five factors are expected to follow the quality guidelines.

Ten Principles of GMP

1. Conduct GMP audits regularly.
2. Prioritize quality and integrate it into the workflow.
3. Create Standard Operating Procedures (SOPs). 
4. Enforce/Implement SOPs and work instructions.
5. Validate effectiveness of SOPs.
6. Design and use working systems.
7. Maintain systems, facilities and equipment.
8. Document procedures and processes.
9. Develop job competence of workers.
10. Prevent contamination through cleanliness.

Conclusion

A pharmaceutical plant is required for manufacturing different pharmaceutical products. A location needs to be fixed, and a proper pharmaceutical plant layout has to be made before the construction of the plant. There are different types of plant layouts, each following the GMP standards. A good manufacturing plant has minimal risks of human errors and minimizes cost and wastage of materials. It has suitable working conditions for maximum efficiency. The layout of the plant should be such that the production process should go on smoothly between different points. It also ensures that the pharmaceutical plant layout has a logical order according to the steps of production.

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