High quality product to market
Fermion’s quality control and quality assurance specialists ensure the GMP compliance of an API at each stage of development.
This five part series details the phases of an API contract manufacturing project at Fermion. In the fifth part we look at quality management, and how it’s present throughout each development phase. Read Part 1, Part 2, Part 3, Part 4.
In the previous parts of this article series, we’ve looked at the different stages of a new API contract manufacturing project: from preparing the proposal to the automated and contained manufacturing of the final product. This last part focuses on a key element that’s built into the project throughout all these phases: quality.
Fermion’s Laboratory Manager, Kaisa Koli, from Analytical Development and Quality Control,and Quality Assurance Manager Jaakko Nousiainen share insights into how consistent quality is ensured for contract manufacturing clients.
1) The Quality Management is a key player throughout the lifecycle management of APIs
In Fermion’s API projects, the quality organization is a key participant from the very start, working in harmony with R&D in the development stages and later with the API production staff.
“Our chemists develop all the required API and intermediate analytical methods for each phase of a new API project starting from process development, and throughout the different clinical phases, up to commercial production,” Koli says. “The methods are developed based on detailed impurity profiles from the process development phase; they are proven to be reliable and specific for the intended purpose. We also make sure all our method validations meet the relevant ICH and FDA guidance.”
The goal is to eliminate any potential quality risks for the client, and ultimately, to ensure patient safety.
“In the end, patient safety is really at the core of everything we do”, Nousiainen says. “Our job is to ensure that no product batches manufactured at Fermion contains any risks for the client or the final user.”
2) Added value with compliant quality requirements
The quality requirements and analytical methods of an API must be both reliable and cost-effective. Carefully planned, efficient testing and evaluation combined with a Quality by Design approach ensure the right quality level at each stage of the project and support the development of effective manufacturing processes.
“We must do the right things at the right time, and avoid producing over-quality to the detriment of yield or cost,” Koli says.
Fermion has received very positive feedback from CMO clients for its high-quality analytical method development for API used in clinical trials.