Q1: Designing GMP facilities can be a big challenge to both clients, engineering, and construction firms. Short deadlines, market demands – from the client side – and strong regulatory constrains are only a few to mention. How does Nordika contributes for a smooth path throughout a GMP project life cycle?
Nordika develops projects for the Pharmaceutical Industry for a long time now. Our team is composed by highly experienced professionals and SME’s who can tackle most of the challenges that comes together with GMP projects. From Process Engineering to Building, Structural, Utilities, Electrical, Automation and Fire Fighting, our teams are up to date with the latest Codes and Standards to provide a high-quality design. Our Validation team integrates all regulatory requirements in the engineering design, procurement and construction phases, to assure full adherence to the agency’s requirements. Our experience with pharmaceutical industry makes a big difference during the construction phase, where planning and control are key to a successful assembly. Of course, keeping all the procedures within a good quality management system also helps a lot.
Q2: What is the role of the Quality Management System in Nordika operation?
We are very proud of our Quality Management System. Nordika invested a lot of energy and resources to produce a robust QMS that integrates procedures, guidelines, templates, and updated codes for all our activities. It consists not only as a guide for engineering design, construction, and validation, but it includes HR, Project Controls, Finance and Sales. The QMS is a very important tool that allow us to control the and monitor the projects in a consistent way. It also allows us to continuously improve our processes.
Q3: What should we expect from Nordika in the future?
We are convinced that the investments in pharma projects will be enough to configure a healthy economic environment for the years to come and we want to be ready for new challenges. This means we are focused on consolidating and expanding our operations. We will continue investing time and money to consolidate our quality-oriented services, with special attention to knowledge management with innovation. Currently, we will roll out a new Good Engineering Practices Platform, which includes videos explaining our project execution model (OurModel), a collaborative wiki page with articles related to our good practices (OurWiki), a community of experts to share technical knowledge globally (COE), and finally an AI tool to find lessons learned across all projects we have completed in the past.