Your GMP Partner in Pharma

The pandemic has had the world holding its breath. Normal life has been suspended as we waited – and hoped – for pharmaceutical and biopharmaceutical companies to develop and mass-produce life-saving vaccines. The speed at which this has happened is remarkable and everyone involved deserves great credit – as do other drug developers working hard to ensure the patients they serve do not miss out as a result of COVID-19. The urgency of the task and the constraints placed upon companies during the pandemic has underscored the importance of efficiency. How can we do things faster without sacrificing safety?

This is especially true for GMP, which refers to guidelines that govern quality assurance of the processes and environment in the production of pharmaceuticals and active ingredients, as well as cosmetics, food, and feed. In pharmaceutical production, quality assurance plays a central role, as quality deviations can have a direct impact on the health of the consumer. Quality is something that cannot be rushed – here, lives are at stake.

We work with pharmaceutical companies to provide GMP-Ready HPLC equipment (instruments, parts, and systems) and to help them with GMP, where we offer consultation, engineering, instrument and software qualification, training, maintenance contracts, and technical documentation – the “great mountains of paper.” Over the years, we’ve learned the importance of flexibility and responsiveness, as well as the recipe for good GMP-compliant products.

From the initial contact to a system installation and qualification, a “GMP project” can take months of intense teamwork. During that time, our partners are allocated a technical engineer to accompany and coordinate the project. We have found that consistency in support is key to the smooth handling of any project.

Typically, a GMP project starts with our partners sharing a list of requirements (the User Requirement Specification). These documents are usually lengthy and detailed, including the functional, technical, and regulatory specifications that must be met, as well as the services and procedures required. The KNAUER team then meticulously works through those requirements and puts together a proposal for a technical solution. Once the customer is happy with the proposal, the project moves forward and we manufacture the instruments, produce the necessary documentation, and – together with the customer – qualify the system.

This generally takes place in two stages: the first qualification happens at the KNAUER site (a factory acceptance test, FAT) and the second occurs at the customer site after installation (a site acceptance test, SAT). Next, those individuals responsible for operating the equipment must be trained. Only at that point is the system ready for integration into its true production environment, which is handled by our partners.

Another significant service we provide is material documentation. When supplying equipment to a regulated environment, every component within a system that comes into contact with a pharmaceutical product during production (wetted parts), needs to have the necessary quality while also complying with the necessary regulations. KNAUER provides a range of documentation including material statements, TSE/BSE certificates, USP Class VI certificates, FDA statements of compliance… The list is long and ever growing.

Of course, it’s crucial that our own staff are fully versed and trained in GMP guidelines. And we have established “GMP Champions” who regularly review regulatory affairs and can be called into play when needed. They also regularly train our staff through our own internal training system, which ensures colleagues working on GMP projects are well aware of the expectations required of them. But our greatest teachers are our customers. We learn continuously from their needs and challenges.

We are now expanding our GMP compliant product portfolio from LC systems to other areas, such as Impingement Jets Mixing Skids for high-flow production of nanoparticles (LNPs, microemulsions, and so on) and other dosing applications. It’s an exciting development, but we’re sure the foundational quality principles we’ve established in LC can be applied anywhere – and we’re very excited. Overall, we’re passionate about carrying the GMP burden for our customers so they have more time – especially given the past 18 months – to do what they do best: manufacture safe and effective drugs.

www.knauer.net