How to Build your lab from scratch to compliance
*By Bárbara Guelfi, founder and CEO of Kivalita Consulting
Hello! In this article, I will share with you some key points and best practices for building a lab from scratch to compliance. With expertise, it is possible to create a laboratory project of excellence, mitigating costs, waste and rework.
Initially, we will highlight that it is necessary to establish a clear goal, because it will define what is the ideal type of laboratory to be idealized and built. After this step, it is important to consider the best property, furniture, equipment, licenses and other regulations that will ensure the full functioning of the laboratory in question. Follow more about each of these points, below.
Creating good strategic planning
Like any relevant project, it is always important to create a good strategic planning, considering a period of five to ten years. In fact, this will be the period that will define that your laboratory project does not have to undergo new adaptations. Keep that in mind!
Defining the target audience, products and services
Determining both the target audience and the type of product or service (i.e.: cosmetic, medicine, sterile, hormones, insums, water analysis, waste analysis, among others), will be the main impacting factors when dephyding the types of equipment and, finally, the type of laboratory. In this case, whether the laboratory will be: physical-chemical; calibration and metrology; microbiology and parasitology; biotechnology; ecotoxicology; toxicology. Additionally, the products to be analyzed can be: medications; cosmetics; sterile; water and waste analysis; hormones; microbiological analysis;
Have you thought about the best space?
It is not always easy to choose a good property to live in, so imagine you need to make that choice thinking about a business in the area of LifeScience? There are many criteria to consider, especially a zoning location that allows laboratory activities and that will impact the logistics of the products or services to be delivered to the market.
Furniture: ergonomics and safety
Another important question is the furniture: what to do with furniture already in the property or which furniture should be more suitable to meet the needs of the project? Remember that furniture manufactured for laboratory use considers ergonomics and safety specifications (NRs) specific to your laboratory purposes.
Defining the best equipment
Determining the ideal equipment for the project also requires good technical knowledge to comply with the desired on-site activities. There are some like: chemical chapel, shower wash, laminar flow and air system. The tip is to specify user requirements (URS/ERU), indicating mandatory and desirable requirements to avoid future usability issues and repurchase expenses.
What are the licenses to consider?
The definition of licenses is a critical point that requires expertise, since they need to be 100% aligned with the products and services offered, location and public to be served. For example, some basic licenses to consider are: the Occupational Health Medical Control Program/Environmental Risk Prevention Program Operating License (PCMSO/PPRA) - which requires an open CNPJ with CNAE in laboratory activities -; the inspection report of the Fire Department (CCB), sanitary license; the Technical Evaluation Report (LTA); the Certificate of Movement of Environmental Interest Waste (CADRI); in addition to the QMS (if laboratory activity needs to comply with Anvisa/MAPA regulations).
In addition to the points mentioned above, it is essential to consider whether the laboratory will be an importer for defining product records and nationalization measures. All these and other factors included in the project will support the criteria for issuing the appropriate regulatory licenses - in the short, medium and long term - inherent in the laboratory.
How about delving into the topic?
There is still much to share about laboratory projects from scratch to compliance. We, Kivalita Consulting together with our partner Comtec Laboratories Engineering, have extensive knowledge in the area and reliable partners who can support you in all stages of the idealization and construction of a laboratory project, ensuring that at the end it complies with operating regulations and addresses the requirements for full operation in the short term, medium and long term.
You can also learn more by watching our live on this topic: "Laboratory projects: where to start? ", alongside Anderson Vieira, who is managing partner of Comtec Laboratories Engineering and chemical engineer. Live is available on Kivalita Consulting's YouTube channel by clicking here.
If you wish, schedule a conversation on the subject with one of our experts! It will be a pleasure to talk about it with you!