A fast-growing pharmaceutical company was faced with the challenge of transforming its existing sub-standard premises into a state-of-the-art NRM analysis lab. The project was to be carried out in the midst of a burning Covid-19, with all the additional obstacles that the pandemic brought with it. The complexity of building a high-tech lab of this kind required a comprehensive understanding of the industry, the regulations and, not least, the risks and pitfalls faced. The goal? A satisfied customer with a new high-tech NMR analysis lab.
Challenges
During the implementation of the project we faced several challenges and there were a few factors that were prominent from the start. The pandemic. The project was carried out in the middle of the ongoing pandemic and at the same time as our customer was going through a major expansion. Despite a clear timeframe for the project (the instruments were already ordered and would be delivered within 4-5 months), the focus and resources of the business needed to be prioritized for other projects.
Another challenge was the need to empty a warehouse before the refurbishment could begin. Unfortunately, there was a shortage of available space, which required careful planning to manage and optimize the use of existing spaces. In addition, our project manager faced significant challenges in converting the existing premises, which previously served as a common storage area for several departments, into a GMP lab. The transformation required not only meeting strict ventilation, environmental health and safety (EHS) requirements, but also adapting to the specific requirements of the Nuclear Magnetic Resonance (NMR) equipment.
Objectives
The assignment was to help our client convert existing premises into a regulatory compliant NMR analysis lab. The project included the remodeling of the existing facility, the purchase, installation and qualification of new HVAC, oxygen alarm and compressed air systems, and the implementation and qualification of new equipment, according to governing regulations.
Managing this type of project requires a project manager with extensive knowledge of the required regulations, which may include GMP/GLP, and an understanding of specific construction regulations. It is a great advantage if the project manager also has experience of different industries, is used to leading qualification and is a key person who can be the bridge between company and supplier.
"For me as a project manager, the great thing is to solve the customer's needs in the most efficient, safe and professional way possible. Life Science is a highly regulated industry and it is important to comply with regulations, risk analysis and to be responsive" - Responsible Project Manager.
Implementation
In the early stages of the project, we realized that despite the importance of the NMR lab to the business, it would be a challenge to ensure sufficient priorities and resources for the project. Therefore, to better support our client, we proposed a senior project manager with experience in lab construction and a deep understanding of the client's needs. In addition, the project manager led the change control process and conducted extensive risk analysis, both technical and environmental, health and safety (EHS). This also included formulating specifications and planning the layout of the lab, compressed air system and EHS measures.
The project manager also took on the responsibility of identifying and evaluating suppliers to ensure a high quality delivery, from the start of the refurbishment to its final inspection. In addition, the project manager played a key role in leading the qualification process for the lab and the compressed air system.
To ensure the smooth operation of the new lab, the project manager wrote the SOP (Standard Operating Procedure) and WI (Work Instructions). Other relevant documents were also updated for the affected activities, such as the VMP (Validation Master Plan), SMF (Site Master File) and access control WI, contributing to a comprehensive and well-functioning working environment for the new NMR lab. Through these actions, the project manager demonstrated an impressive ability to navigate the complexity of the project and deliver successful results.
Result
These accumulated efforts resulted in the laboratory being completed in time for the delivery of the instruments and NMR is now used as a support for Quality Control (QC) in the release of the customer's products. During this period, our customer was able to focus on other ongoing projects and more important line activities which resulted in the customer saving both resources and time in the end.
You are welcome to contact us if you are facing similar challenges.
