By Novo Nordisk…
Novo Nordisk Pharmatech showcases cGMP Quats manufacturing facilities
Koege, Denmark: – World-leading insulin and quaternary ammonium compounds (Quats) specialist Novo Nordisk Pharmatech A/S emphasizes the benefits of keeping all processes in house at its expanded cGMP manufacturing and headquarters site at Køge, south of Copenhagen.
Being able to manufacture pharmaceutical grade quaternary ammonium compounds (Quats) to full Good Manufacturing Practice (GMP) standards reinforces Novo Nordisk Pharmatech’s place as the leading supplier of Quats for a wide range of pharma, medical and other applications.
Controlling for quality, purity and consistency
The company has produced an article explaining how it ensures the highest quality, purity and batch-to-batch consistency standards at the Køge site (see Resources).
To ensure full cGMP compliance and certification, Novo Nordisk Pharmatech ensures that every aspect of the Quats manufacturing process is under its own control, from the scrutiny of suppliers to the finished product.
The quality process begins with sourcing the finest raw ingredients, which are sampled to check they are in specification. Throughout manufacturing, critical parameters for each process, such as temperature or PH level, are constantly monitored to make sure they are under full control.
As each batch is finished, inspectors perform a specific analysis based on the intended customer’s requirements to deliver a Certificate of Analysis.
“Good manufacturing practices are embedded in everything we do, as we strive to keep all our operations completely uniform,” says International Sales Manager Phil Stafford.
Quality as a team effort
Tightly controlled processes require not only the combined efforts of the 70-strong manufacturing team but determined centralisation.
All activities and teams are gathered on the Køge site, including Research & Development, Quality Assurance (QA), Quality Control (QC) and Sales and Marketing.
“This brings us significant advantages in terms of agility. For example, if we need to take a sample of something in our production facilities, it’s just a 50m walk to our QC lab. While others might send off their samples and wait days for the results, we can have ours within the hour, stating whether we need to stop and change something or whether we can continue production,” Stafford explains.
Building on knowledge and experience
Novo Nordisk Pharmatech (formerly Ferrosan Fine Chemicals) has been manufacturing Quats for more than 70 years with many of the essential processes proven and perfected in long practice.
“As a result, our manufacturing teams bring a high level of knowledge and experience to secure the quality of our products. Many know their process so well that they will almost immediately have a hypothesis if they come across an irregularity,” observes Mr. Stafford.
“Having R&D onsite is also a benefit here. Since they built the process, they know what critical parameters to monitor to help control our processes,” he adds.
About Novo Nordisk Pharmatech A/S
Novo Nordisk Pharmatech A/S is a global and leading manufacturer of pharmaceutical aids for the pharmaceutical and biopharmaceutical industries. The company specializes in producing quaternary ammonium compounds (Quats) used as active pharmaceutical ingredients (APIs) and excipients as well as delivering Recombinant Insulin for use in cell culture media to enhance cell growth and viability, and productivity.
Novo Nordisk Pharmatech A/S helps the world´s largest pharmaceutical and biopharmaceutical industries reduce their risk for raw materials by using pharma-grade products with a high level of consistency, purity, quality, and reliability.
Novo Nordisk Pharmatech A/S was established in 1949 as Ferrosan Fine Chemicals and acquired by Novo Nordisk in 1986. The company is operating as a division of Novo Nordisk A/S from Køge, south of Copenhagen.
You can learn more about Novo Nordisk Pharmatech at novonordiskpharmatech.com.
Click on Take a look inside our cGMP Quats manufacturing facilities to download full article.