Expert Profile
Muniza Chaudhry obtained her MSc at Copenhagen University in Chemistry, specializing in Quantum Chemistry. During her career she has gained experience from bigger pharma companies as well as mid-sized companies in both Denmark and the Netherlands within Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) in Quality Assurance. She is passionate about making a difference to the lives of patients and contributing to compliant drug development is a big part of bringing good quality products to those in need.
Insights
Quality Assurance (QA) is pivotal in the drug development process as there are regulations governing best practices at each stage of development. This is in place to ensure patients get the most efficacious and safe product possible. Although very early R&D is not a regulated area in terms of GxPs, adhering to quality standards from the beginning enhances the prospects of success in later stages. In this blog, Muniza Chaudhry describes the role of QA at Ncardia and how it impacts the drug development programs of our clients.
“It is important to embed quality in R&D from the very beginning. If the early development is conducted with poor quality it is more time-consuming to get it up to speed if needed for filing purposes later on. Regulatory agencies may ask for more information supporting the decisions made in earlier stages. Implementing QA ensures traceability in terms of scientific conduct and decision making. This traceability is key to be able to go back and understand what happened and why we chose to do as we did in the past, if questions are raised at a later time point.”
As explained by Muniza, the importance of having a QA department in place is recognized at Ncardia, even as a CRO providing early discovery services. The aim of QA is to ensure processes are in place to deliver a service that meets client’s expectations and facilitates future stages of their journey. As part of their functions, the QA team defines and continuously optimizes processes, ensures proper data documentation and storage as well as the adequate training of new employees.
“Although Ncardia does not develop therapeutic products, it provides services to clients who do. Regardless of the stage of drug development our clients are at, we aim to ensure traceability and consistency in our deliverables. Our philosophy is to foster a sense of shared responsibility for upholding quality standards among every single person. All team members are not only accountable for maintaining these standards, but also empowered to ensure their adherence.”
Ensuring high reproducibility when using human models in drug discovery and development can pose challenges, particularly for those clients who lack experience with stem cells. However, Muniza and the other members of QA work closely with the expert and skilled scientific Ncardia team to optimize consistency and reproducibility.
“One of the things I deeply appreciate about working at Ncardia is the collective to constant improvement. This commitment allows us to successfully integrate QA functions into our processes, thereby enhancing the value we provide to clients.”
Are you wondering how iPSC technology could advance your therapeutic development programs? Contact our experts