GMP (Good Manufacturing Practices) is a critical system. It guarantees that the creation of any product a consumer obtains was done so under meticulous regulations and standards. Manufacturers in healthcare industries, pharmaceutical companies, and small laboratories must abide by these regulations. An extension of this term is CGMP, which means “Current Good Manufacturing Practices.” This implies that the systems and technologies must be up-to-date in order for its operations to run smoothly. The same thing applies to GMP facility design; it must be perfect to succeed.
The importance of GMP facility design
What goes into the layout and construction of GMP facilities is different from what goes into, say, office space construction. GMP facility design for scientific laboratories and manufacturing sites requires the right brand of knowledge and experience. It’s obvious that regulatory and workflow requirements are key to success when it comes to building or renovating these facilities. A common belief with this particular topic is that you need to integrate “build-in” quality. This means that a product’s quality should be intrinsic at every phase of the manufacturing life cycle. It is in contrast to relying solely on Quality Control tests that occur at the end of the process.
Elements of the layout
The development of a facility that is responsible for manufacturing products should consider the following factors:
- All facilities need to operate in accordance with GMP. Additionally, they need concrete proof (ex. records or documents) to verify the findings.
- The facility needs a written quality policy under which it performs.
- A Quality Assurance (QA) unit needs to be present, but as a separate entity within the organization. Additionally, there should be irrefutable proof that there are no conflicts of interest. The QA unit must be the only one with the authority to reject or approve the drug manufacturing materials and processes.
- The QA department has to regularly assess the production documents. This way, they can ensure the following and documentation of the correct procedures.
- The location of the facilities should not have the workers or the product be subject to infestations and toxic fumes.
- The facility’s layout should be suitable for manufacturing work. Moreover, it must provide enough space and not create any contamination to the environment.
- There should be adequate space in the facility for its laboratory, as well as enough equipment. Additionally, proficient personnel with proper training and experience must be present to perform the testing and other operations.
- The facilities need to have previously gone through risk assessment and auditing. Furthermore, they need to prove that they abide by good manufacturing practices.
- The safety procedures of the facility must be up to date. Plus, it must have a security policy in place.
GMP facility equipment placement
Integration of the right equipment into the creation of the facility is as important as the other facets of construction. It greatly benefits GMO facility design, especially when you see how it all comes together. There are several things one should take into consideration at this point:
- All the equipment for drug holding or the manufacturing process must have the appropriate design and size.
- The location of the facility’s equipment must be fitting for each of them.
- There should be a designated building or room that holds the equipment. Additionally, it needs to be under lock and key. This storage facility must adhere to the set CGMP.
- Machine surface materials have to be non-reactive, non-additive, and non-absorbent to the raw materials and the complete product.
- There should be design and operation precautions to make sure that operating substances do not come into contact with the raw materials or the final product. These substances include lubricants and coolants, among others
- Ineffective equipment should be put into storage in a specific area with a clearly marked status.
- Written procedures must be available for all equipment in the facility that helps with the manufacturing. Likewise, with the holding of raw materials or the final product.
- Drug or product production should not include the use of asbestos filters.
Keep GMP facility design as a priority
Good manufacturing practice facilities are crucial, so their designs should reflect that significance. A layout lacking in thought and/or operational convenience will surely affect its system. For project management and consultation services, don’t hesitate to contact our Toronto construction location and we will provide assistance for your project. Be sure to check out our article, An Exploration of Pharmaceutical Plant Construction, to learn more about the construction of these types of facilities.